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VACCINE STRATEGY 

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'HUMAN CHALLENGE' 

TRIALS BEGIN IN UK

editor’s note 

November 2020 / Vol. 7 / Issue 7 

Founder & Managing Editor 

CH Unnikrishnan 

Executive September Editor 2020 / Vol. 7 / Issue 5 

S Harachand 

Founder & Managing Editor 

Science CH August Unnikrishnan 

Editor 2020 / Vol. 7 / Issue 4 

Dr 

Executive 

Rajanikant 

Founder 

AUGUST 

& 

Editor 

Vangala 

2018 

Managing / Vol: 

Editor 

Consulting S 5 / Issue: 4 

CH 

Harachand Editors 

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Dear Doctor, 


Dear The Doctor, unlocking process is almost complete now, though the pandemic 

continues Dear Doctor, 

rage. New positive cases reported among those with 

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concept Indeed, of the natural latest herd WHO immunity survey has comes a list of the 165 billion-dollar SAR-CoV-2 vaccine question: candidates How 

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resistance urgently. South Asian That, and population—uncovering however, prophylactic doesn’t therapy answer the trials the story question for behind COVID-19. of whether first-ever such Genome-wide 

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population. delve 

the best 

Dr 

Wishing 

deep V Ramprasad, of into views an insightful 

the and high-wire CEO analyses reading, 

of MedGenome, acrobatics from the that masters which is COVID-19 initiated each vaccine the field. CAD We development. 

PRS present study, you also this talks 

about Also specialised the in this greater edition knowledge impact is a special that vehicle it feature can that make plugs on the in India, you latest into scientific Straight the emerging advancements Talk of world this edition. of 

a most care promising seamlessly. cardiovascular Come, let’s treatment join hands involving this information one-time gene journey. editing. Our 

Wishing you an insightful reading, 

guest on Straight Talk this month is Sameer Sheriff of iPC Health who explains why 

we need CH Unnikrishnan 

to get a grip on India’s high levels of medical error deaths urgently. 

Wishing editor@futuremedicineindia.com 

you an insightful reading, 

C H Unnikrishnan 

editor@futuremedicineindia.com 





www.futuremedicineindia.com futuremedicineindia FutureMedIndia 

AUGUST 2018/ FUTURE MEDICINE / 3

RESEARCH POLICY SPECIAL FEATURE FM COVID-19 UPDATES 

Vol 7 Issue 7 

November 2020 

₹ 250.00 


PAGES 100 

NOVEmbEr 2020 

FUTUrEmEDICINEINDIA.COM 

of 

KERALA 

SPECIAL 

FEATUrE 

T-CELL DRIVEN 

VACCINE STRATEGY 

HErD ImmUNITY A DISTANT DrEAm FOr INDIA, 

SUGGEST SErO-SUrVEYS 

IMMUNE 

NDHM: IMA 

UP IN ARMS 

@ 

COVID-19: 

MOUNTING 

HUMAN COST 

'HUMAN CHALLENGE' 

TRIALS BEGIN IN UK 

REGULAR FEATURES 

06 Letters 

08 News updates 

38 Drug approvals 

50 Research snippets 

55 Hospital news 

60 Devices&gadgets 

64 Gynecology & 

paediatrics 

66 Research 

74 Technology 

77 Clinical trials 

90 Guidelines 

96 Calendar 

98 Holy grail 

Columns 

25 TRIALOMICS 

Dr Arun Bhatt 

54 THE CELLVIEW 

Dr Rajani Kanth Vangala 

56 

SPECIAL FEATURE 

MOUNTING 

HUMAN COST 

FM examines the mounting human 

cost of the COVID-19 pandemic at a 

time when the toll from SARS-CoV-2 

crosses the 1 million mark 

12 

POLICY 

DIGITAL HEALTH 

MISSION IN THE 

CROSSHAIRS 

Not enough safeguards 

for medical records 

in the policy blueprint, says IMA 

46 

STRAIGHT TALK 

“PATIENT PRIVACY 

AND DATA 

PROTECTION ARE 

OF PARAMOUNT 

IMPORTANCE” 

Seema Arora 

National Marketing Head 

ResMed India

16 

FM COVID-19 UPDATES 

FIRST ‘HUMAN 

CHALLENGE’ 

TRIAL ON 

COVID-19 

TO BEGIN IN UK 

80 


KERALA TO TAP 

MEDICAL 

VALUE TOURISM 

LEVERAGING 

SKILLSETS 

IN MODERN, 

TRADITIONAL 

MEDICINE 

It is important 

that the results 

of serosurveys 

to be interpreted 

carefully, factoring 

in their context 

and limitations. 

Dr Chandrakant 

Lahariya 

A leading public 

policy and health 

systems expert 

26 

COVER STORY 

WHITHER 

HERD 

IMMUNITY? 

India’s seroprevalence findings 

suggest that the country is 

nowhere close to achieving 

herd immunity

IN FOCUS SPECIAL FEATURE GENOMICS FM COVID-19 UPDATES 

letters to the editor 

₹ 250.00 


PAGES 100 

OCTOBER 2020 


ALLOWING THE PANDEMIC TO RUN ITS COURSE 

UNTIL MUCH OF THE POPULATION GETS EXPOSED COULD PROVE DISASTROUS 

FALLING 

FRONTLINE 

COSTLY 

STRATEGY? 

COVID-19 

REINFECTION 

VACCINE FOR 

GALLBLADDER 

CANCER? 

BLOOD THINNERS ON 

COVID19 PATIENTS 

Epidemic curve: Stay 

cautious! 

Hi 

Since its outbreak in late 2019 

in China COVID-19 had spread 

around the globe taking many 

lives and creating a state of 

delirium that everyone had 

almost shared equally. In 

case of India which now has 

the second most number of 

the COVID-19 cases around 

the world after the U.S, the 

situation has been a lot worse. 

With the government scaling 

up its testing capacity, the 

positivity rate of the infection 

appears to have started 

falling since October. 

However, now the cases have 

begun to show an increasing 

trend in Kerala which had 

its infection under control 

a few months ago until the 

restrictions were lowered 

during the festive season. This 

implies that the assumption 

that the country has reached 

the peak of the epidemic 

curve could be based on a 

flawed estimation. Let us for 

now not have an unrealistic 

consolation based on any 

partially-known epidemiology. 

We still have a densely 

populated group of 

people across the country 

where the virus might not 

have reached yet. We may 

not be able to predict when 

the epidemic will reach the 

curve and and explode. Hence 

it is better to stay cautious 

and maintain necessary 

measures. 

Mahesh Sawant 

Pune 

Ensure safety of 

doctors 

Dear Editor 

India has always been keeping 

up the fight against the virus 

helping contain the infections 

and cure the affected with 

the continuous help from our 

dedicated medical staff and 

authorities. However, many 

doctors among other people 

did lose their lives fighting 

the pandemic. As FM has 

mentioned in one of your 

recent articles- “India loses 

more doctors to COVID-19” it 

is revealed that the doctors 

suffer four times the mortality 

of ordinary citizens in this 

country. With a population 

so vast and the given 

situation of the poor work 

environment, high numbers 

of casualties and lack of 

standardisation of PPE kits 

makes our doctors more 

prone to the infections. 

Every single doctor is of 

utmost value as his/her 

service could save several 

lives. Meanwhile, during this 

time there have also been 

various cases of medical 

negligences reported across 

the country which resulted 

in the death of COVID-19 

patients. 

Dr Gaurav Sharma 

Lucknow 

& 

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news updates 

NOBEL PRIZES 2020 

HCV discoverers 

honoured 

The 2020 Nobel Prize in 

Physiology or Medicine is 

awarded to Harvey J Alter, 

Michael Houghton and Charles 

M Rice for the discovery of the 

hepatitis C virus. 

Alter studied the 

transmission of hepatitis as a 

result of blood transfusions 

and showed the existence 

of a third, blood-borne viral 

pathogen —other than HAV 

and HBV. 

Houghton and his 

colleagues identified the 

new kind of RNA virus that 

belonged to the Flavivirus 

family on the basis of genetic 

material from infected 

chimpanzees and named it 

the hepatitis C virus. 

A team led by Rice 

characterised a portion of 

the hepatitis C genome 

responsible for viral replication 

using genetic-engineering 

techniques demonstrating 

its role in causing liver 

disease. 

This pioneering work 

has paved the way for the 

development of screening 

methods that have 

dramatically reduced the risk 

of acquiring hepatitis from 

contaminated blood and has 

led to the development of 

effective antiviral drugs. The 

harsh and poorly effective 

treatments of yesteryears 

for the infection have been 

replaced by drugs that directly 

block the virus. 

HCV induced hepatitis is 

now almost a curable disease 

and the lesions associated 

with infection are often 

reversible. Clinical studies 

have shown that shortterm 

anti-viral treatment 

cures more than 95% of the 

patients, including advanced 

cases who failed to respond 

to previous therapeutic 

modalities. 

71 million people 

worldwide are chronically 

infected with hepatitis C, 

which causes nearly 400,000 

deaths per year, mostly from 

cirrhosis and liver cancer, 

according to WHO. 

In 2016, spurred by the 

development of effective 

treatments for hepatitis C and 

expanding access to hepatitis 

B vaccination, the 194 

member states of the WHO 

committed to eliminating viral 

hepatitis as a public health 

threat by 2030. 

I am overwhelmed at the 

moment, but so pleased that 

this originally obscure virus has 

proven to have such a large 

global impact. 

Harvey J. Alter, M.D 

Senior Scholar 

NIH Clinical Center’s Department of 

Transfusion Medicine, USA 

You cannot stop an epidemic 

as large as [Hepatitis C] or 

Covid[-19] just with good 

therapy — you absolutely have 

to have a vaccine to really curb 

the transmission across the 

world. 

Michael Houghton 

Professor, Department of Medical 

Microbiology & Immunology 

University of Alberta, Canada 

It shows you what can be done 

if people really mobilise and 

work together. 

Charles M Rice 

Rockefeller University, New York City 

8 / FUTURE MEDICINE / November 2020

CRISPR-Cas9 back in spotlight 

Emmanuelle Charpentier and Jennifer 

Doudna shared the Nobel Prize for 

Chemistry for developing the precise 

genome-editing technology. 

Charpentier, now at the Max Planck 

Unit for the Science of Pathogens in Berlin, 

and Doudna, at the University of California, 

Berkeley, have developed CRISPR–Cas9 

gene-editing tools, a technology that allows 

to make precise edits to the genome and 

has swept through laboratories worldwide 

since its inception in the 2010s. 

Using these, researchers can change the 

DNA of animals, plants and microorganisms 

with extremely high precision. This 

technology, which has had a revolutionary 

impact on the life sciences, is contributing 

to new cancer therapies and may make the 

dream of curing inherited diseases come 

true. 

Using the CRISPR/Cas9 genetic scissors, 

it is now possible to modify genes in cells 

and change the code of life over the course 

of a few weeks. 

“There is enormous power in this genetic 

tool, which affects us all. It has not only 

revolutionised basic science, but also 

resulted in innovative crops and will lead to 

ground-breaking new medical treatments,” 

said Claes Gustafsson, chair of the Nobel 

Committee for Chemistry, announcing the 

prize. 

Clustered regularly interspaced short 

palindromic repeats (CRISPR) is a microbial 

‘immune system’ that prokaryotes use to 

prevent infection by viruses called phages. 

The CRISPR system gives these microbes 

the ability to recognize precise genetic 

sequences that match a phage or other 

invaders and target these sequences for 

destruction using specialized enzymes. 

These enzymes, known as CRISPRassociated 

proteins (Cas), including one 

called Cas9, have been identified previously. 

But Charpentier identified another key 

component of the CRISPR system, an RNA 

molecule that is involved in recognizing 

phage sequences, in the bacterium 

Streptococcus pyogenes, which can cause 

disease in humans. 

In a collaboration, the duo isolated the 

components of the CRISPR–Cas9 system 

and showed that the system could be 

programmed to cut specific sites in isolated 

DNA. Their programmable gene-editing 

system continues to tweak and improve 

CRISPR and to identify other gene-editing 

tools. 

This tool has contributed to many 

important discoveries in basic research, and 

plant researchers have been able to develop 

crops that withstand mold, pests and 

drought. In medicine, clinical trials of new 

cancer therapies are underway. 

Emmanuelle Charpentier 

Jennifer A Doudna 

Emergency 

department 

must in medical 

colleges: NMC 

The National Medical 

Commission (NMC) 

has made it clear that all 

medical colleges offering 

MBBS courses must have a 

Department of Emergency 

Medicine. 

Releasing the latest 

“minimum requirements 

for MBBS admission 

regulations 2020” for public 

comments, the apex 

regulator mandated that 

the emergency department 

should have at least 

30 beds. 

The regulations will be 

applicable to medical 

colleges being established 

from the 2021-22 academic 

session. 

The draft guidance 

stipulates the infrastructural 

facilities requirements for 

medical colleges offering 100, 

250 and 500 admissions 

annually. All the institutions 

offering undergraduate 

education are required to 

have a college building, 

laboratories, tutorial rooms, 

library, hostels and bed 

distributions. 

For medical colleges 

November 2020 / FUTURE MEDICINE / 9

Dr J A Jayalal 

Dr J A Jayalal elected as 

president of IMA 

Dr J A Jayalal, a government medical 

practitioner from Tamil Nadu, 

has been elected as the national 

president of the Indian Medical 

Association (IMA). 

Currently, associate professor of 

surgery at Tirunelveli Medical College, Dr 

Jayalal will take charge as the president 

of the professional body of doctors 

having nearly four lakh doctors as 

members, on December 27, an official 

statement said. 

Dr Jayalal has also served as Hon. 

General Secretary for IMA in Tamil Nadu 

state, and the National Coordinator for 

the academic wings of IMA. 

which are being established 

from academic session 2021- 

22, the body establishing it 

should own and manage a 

fully functional hospital with 

a minimum of 300 beds. It 

should have the necessary 

infrastructure and facilities 

and will be capable of being 

developed into a teaching 

institution. 

The regulations propose 

that admissions shall not 

be made at any stage unless 

the requirements laid down in 

relevant Minimum 

Standard Requirement 

Regulations for annual MBBS 

admissions and phase-wise 

requirements for the grant of 

permission under section 10A 

are fulfilled. 

The National Medical 

Commission (NMC) came into 

force from 25 September 

2020 as the regulatory body 

of medical education and 

practice in India after the 

formal abolition of Medical 

Council of India (MCI). 

Dr Suresh Chandra 

Sharma, the former head 

of Delhi All India Institute 

of Medical Sciences ENT 

department, has been 

appointed President of 

NMC for a period of three 

years with effect from 

September 25 while Rakesh 

Kumar Vats, the Secretary- 

General in the Board of 

Governors of the MCI, would 

be the secretary of the 

commission. 

Dr Jajini 

Varghese named 

Outstanding 

Young Person 

2020 

Dr Jajini Varghese, a 

consultant in Oncoplastic 

Breast Surgery at Royal 

Free Hospital and University 

College London, has been 

nominated for ‘’Outstanding 

Young Person of the World 

2020’’ by a non-profit NGO 

for her scientific contributions 

to diagnosing and treating 

breast cancer. 

The 39-year-old surgeon 

is one of 10 nominations from 

the UK for the international 

award, which honours 

outstanding 

young people under the age 

of 40 every year from across 

110 countries for extraordinary 

accomplishments in 

Dr Jajini 

various fields. 

The Indian-origin doctor 

has been recognised in the 

“Medical Innovation” category 

for making it her personal 

mission to attempt to restore 

the lives of millions of women 

affected by breast cancer. 

The awards will be presented 

to her at a ceremony at 

the 2020 Junior Chamber 

International (JCI) World 

Congress in Yokohama, Japan, 

in early November, reports 

said. 

Currently, Dr Jajini is a 

Fellow of the Royal College of 

Surgeons in Plastic Surgery 

(FRCS) and a Member of the 

Royal College of Surgeons 

(MRCS). She is also on the 

Board of Examiners for the 

MSc in Plastic Surgery at 

University College London 

(UCL). 

After graduating with 

a first class in medicine 

from India, Varghese was 

awarded the Cambridge 

Commonwealth Full 

Scholarship to the University 

of Cambridge to complete 

her M Phil and PhD on the 

“Genetics of Breast Cancer”. 

Her research led to the 

discovery of the ZNF 365 

gene, associated with breast 

cancer, in collaboration with 

Harvard University and the 

Mayo Clinic. 

The mutant ZNF gene, 

which raises the genetic risk, 

is now used in microarrays 

worldwide to identify women 

with a genetic predisposition 

for early detection, prevention 

and prophylactic treatment of 

breast cancer. 

JCI praised Dr Jajini for 

adopting strategies to prevent 

breast cancer by offering 

early screening for women in 

developing countries. 

Dr Ritesh Agarwal 

Dr Ritesh 

Agarwal of 

PGI awarded 

Bhatnagar prize 

Dr Ritesh Agarwal, Professor 

in the Department of 

Pulmonary Medicine of 

Postgraduate Institute of 

Medical Education and 

Research (PGIMER), has been 

awarded the prestigious 

Shanti Swarup Bhatnagar 

Prize for Science and 

Technology for the year 

2020 for his significant 

contributions in the field of 


allergic bronchopulmonary 

aspergillosis (ABPA). 

The award, which is 

named after the founder 

Director of the Council of 

Scientific and Industrial 

Research (CSIR) India, the late 

Dr Shanti Swarup Bhatnagar, 

is given each year for 

outstanding contributions in 

science and technology. 

Prof Agarwal has been 

exploring this ABPA over 

the last 10 years and has 

more than 90 publications 

describing the epidemiology, 

diagnosis and management. 

Over the years, he has 

validated several existing 

diagnostic and classification 

criteria and has proposed 

new ones, which are used 

to diagnose ABPA the world 

over. 

Before his research, 

there was no dosing protocol 

for oral glucocorticoids. His 

studies have shown that lower 

doses of oral steroids are 

sufficient in the treatment of 

ABPA. 

Two of his studies have 

demonstrated the efficacy of 

anti-fungal drugs in ABPA. 

Dr Agarwal completed his 

MBBS in 1998 from Stanley 

Medical College and joined 

the residency programme in 

Internal Medicine at PGIMER 

in 1998. He completed his 

fellowship in pulmonary and 

critical care medicine from the 

same Institute in 2004. 

DoctorC sees 

home service 

grow 5-fold in 

South India 

The healthcare diagnostics 

service provider DoctorC 

witnessed a five times 

growth in their home services 

provided across Hyderabad, 

Chennai and Bangalore in the 

past 5 months serving over 

50,000 families, the company 

said. 

DoctorC provided home 

services during the COVID-19 

pandemic by working with 

NABL accredited labs. 

“COVID-19 has made 

consumers more aware of 

Drug maker AstraZeneca 

Pharma India has 

launched its acalabrutinib 

100 mg capsules 

(Calquence), which is 

used for the treatment 

of various types of blood 

cancers, in India. 

The capsules are 

indicated for the 

treatment of patients 

with mantle cell 

lymphoma (MCL) who 

have received at least 

one prior therapy and 

for treatment of patients 

with chronic lymphocytic 

leukaemia (CLL) and small 

lymphocytic lymphoma 

their health than ever before,” 

said Neehar Cherabuddi, 

CEO & Co-founder, DoctorC, 

in a statement. “With the 

increased adoption of 

telehealth and at-home 

testing, customers are able to 

access high-quality healthcare 

more easily than ever before.” 

DoctorC is currently 

present in 10 cities 

providing services in medical 

diagnostics, teleconsultations 

and lab software. 

AstraZeneca launches 

acalabrutinib in India 

(SLL), AstraZeneca Pharma 

India said in a filing to the 

BSE. 

Acalabrutinib is a 

Bruton tyrosine kinase 

inhibitor, or BTKi. BTK 

inhibition has been shown 

to help treat MCL. 

The effect of the drug 

was measured in a clinical 

study of patients taking 

acalabrutinib which found 

that 80% responded to the 

drug. In this clinical study, 

124 people with MCL who 

had already had at least 

one prior therapy received 

100 mg of acalabrutinib 

twice daily. 

Long-term 

outlook 

stable for the 

healthcare 

sector: ICRA 

The long-term outlook of 

the healthcare sector will 

remain stable despite its 

performance being recently 

affected due to COVID-19, 

says ICRA Ratings, a credit 

rating agency. 

The agency stated that 

the occupancy of companies 

in the sector is expected to 

bounce back substantially, 

to 60% in FY2022, from the 

projected occupancy of 52% 

in FY2021; and the revenue 

growth is estimated to rise to 

~20% in FY2022, against an 

expected contraction of ~19% 

in FY2021, aided by a lower 

base. 

The significant Capex 

in the last five years has 

started contributing to the 

profitability and the Capex 

as well as start-up costs 

of new hospitals are likely 

to be much lower going 

forward, which will also 

aid profitability and debt 

protection indicators over the 

medium term. 

The credit risk profile 

of entities in the sector 

had been on an improving 

trajectory over the last two 

years and notwithstanding 

the near-term disruption, as 

well as given the essential 

nature of the services, the 

sector will report a speedy 

recovery. 

Nevertheless, the 

performance has been weak 

in the last three quarters, 

although worst is behind 

for the sector; Occupancy 

plunged across all the 

players in the sector due to 

lockdown, restrictions on 

the movement of people, 

suspension of international 

flights, a cautious approach 

adapted by patients as well 

as hospitals due to fear of 

infection, sharp drop in OPD 

footfalls etc. 


policy 

DIGITAL HEALTH MISSION 

IN THE CROSSHAIRS 

Not enough safeguards for medical records in the policy blueprint, says IMA 

Even as National Digital Health 

Mission (NDHM) envisions a unique 

personal health ID for every Indian 

citizen, digitized health records and a 

national registry of doctors and health 

facilities, Indian Medical Association 

(IMA) has expressed strong reservations 

over National Digital Health Blueprint 

(NDHB) published recently. The blueprint 

charts out an ambitious plan to bring 

about a digital ecosystem comprising 

digital health networks under NDHM. 

IMA, the largest body of allopathic 

practitioners in the country, has made it 

clear that it does not favour the content 

DIVERSION OF FUNDS FROM 

NATIONAL HEALTH MISSION 

TO NDHM WILL FURTHER 

JEOPARDIZE PUBLIC-FUNDED 

HEALTHCARE, SAYS IMA. 

of the blueprint, its rollout plan and the 

administrative mechanism. 

A major contention of IMA is that the 

country still lacks adequate healthcare 

infrastructure and manpower. “There 

is no standardization of the many 

streams of treatment adopted in the 

country. The government is adopting 

various strategies to allow untrained and 

partially trained individuals to practice 

medicine to address the shortage 

of manpower. The infrastructure 

deficiencies have not been addressed. 

Strategic purchasing through Ayushman 

Bharat has not made any impact due 

to the lack of adequate fund allocation 

and non-empanelment of tertiary care 

hospitals due to unrealistic package 

rates. Primary care has lost its focus and 

NDHM: DIGITIZING HEALTHCARE 

The National Digital Health Mission (NDHM) aims to develop 

the backbone necessary to support integrated digital health 

infrastructure for the country through the creation of personal 

digital health IDs, unique identifiers for doctors and health 

facilities and personal health records. It was announced by 

India’s Prime Minister Narendra Modi in his Independence Day 

speech on 15th August 2020. 

NDHM targets a seamless online platform “through the 

provision of a wide range of data, information and 

infrastructure services, duly leveraging open, interoperable, 

standards-based digital systems.” It has the following 

components as its pillars: 

HEALTH ID 

A unique health ID (UHID) will 

be used for the purposes of 

uniquely identifying persons, 

authenticating them, and 

threading their health records 

across multiple systems and 

stakeholders. 

HEALTH FACILITY 

REGISTRY (HFR) 

HFR is a single directory of 

all the health facilities in the 

country. The registry should 

be centrally maintained, store 

and facilitate the exchange 

of standardized data of both 

public and private health 

facilities in the country. 

The registry must allow 

health facilities to access their 

profile and update it 

periodically with specialties 

and services they offer. 

Facilities should be able to 

e-sign documents such as 

patient records, apply for 

empanelment, have easier 

claims processing, as well as 

improve access to all healthcare 

ecosystem elements. 

DIGI DOCTOR 

It is a single, updated repository 

of all doctors enrolled in the 

nation with all the relevant 

details of the doctors such as 

name, qualifications, name of 

the institutions of qualifications, 

specializations, registration 

number with State medical 

councils, years of experience, 

etc. It would be an essential 

building block of the digital 

health infrastructure of the 

country. The directory must 

be designed to be kept up to 

date as doctors gain skills via 

fellowships and map them to 

the facilities they are associated 

with. 

PERSONAL HEALTH 

RECORDS (PHR) 

A PHR is an electronic record 

of health-related information 

on an individual that conforms 

to nationally recognized 

interoperability standards 

and that can be drawn from 


the proclaimed wellness centres have 

not yet made an impact,” stated IMA. 

IMA alleged that funding for such an 

ambitious project is not appropriately 

described in the blueprint. 

“Any diversion of funds from 

National Health Mission will further 

jeopardize public-funded healthcare, 

especially primary care. There is a 

definite possibility of the plan becoming 

a non-starter if the investment in 

the health sector is not significantly 

increased,” said Dr R V Asokan, 

Secretary-General, IMA. He warned that 

in such a situation, people may have to 

shell out more from their pocket. 

NHM, which envisages the 

achievement of universal access to 

equitable, affordable and quality 

healthcare services in the country, is 

already suffering from a serious shortage 

of funds. 

Privacy under threat 

IMA termed privacy an utmost concern. 

Dr Asokan said that privacy protection 

laws in India are weak and practically 

nonexistent. In NDHB, privacy is assured 

through the consent manager. “Consent 

on a digital platform in a country where 

literacy is low is a cause of concern. The 

consent mechanism described in the 

document is inadequate,” he added. 

IMA has pointed out that accessibility 

of health documents to treating doctors 

is ill-defined in the blueprint. The body 

added that medical records are a 

document equally owned by the treating 

doctor, the patient and the institution 

and the right of accessibility should 

remain with all the three. It termed 

the concepts of data ownership and 

erasure etc described in the documents 

as a violation of this principle and 

objectionable. 

Expressing its concerns over 

data protection, IMA stated that the 

management of analytical data by the 

agency is poorly defined in the blueprint. 

It alleged that the management of 

analytical data will be governed by datamultiple 

sources while being 

managed, shared, and controlled 

by the individual. The most salient 

feature of the PHR, and the one 

that distinguishes it from the EMR 

and EHR, is that the information 

it contains is under the control of 

the individual. 

ELECTRONIC MEDICAL 

RECORDS (EMR) 

Electronic medical record (EMR) 

contains the patient’s medical 

and treatment history from a 

single health facility. EMRs allows 

clinicians to: Track data over time, 

check how their patients are 

doing on certain parameters— 

such as blood pressure 

readings or vaccinations, 

and monitor and 

improve the overall 

quality of care within 

the practice. 

Source: ndhm.gov.in 


protection laws that are practically nonexistent 

at present. 

The umbrella body of India’s 

allopathic practitioners has also 

expressed its reservations over whether 

the union government is vested with 

the requisite legislative powers to 

formulate a pan-India policy to establish 

the mechanism outlined by the NDHM. 

It observed that the legislative powers 

of a state government stemming from 

Entry 6, List II under the 7th Schedule of 

the Constitution cannot be superseded 

by a policy fronted by the union 

government. “Prima facie, it appears 

that the proposed policy would not find 

shelter under the residual powers of the 

Parliament in light of the aforesaid entry. 

It would also raise serious questions 

as to whether a legislation having farreaching 

implications on public health 

can be proposed as a policy,” said 

Asokan. 

Even if it is assumed that the union 

government is competent to bring 

forth the NDHM policy into force, it 

would appear to face hurdles in its 

implementation, observed IMA. The 

practice prevalent in the healthcare 

community vis-a-vis the confidentiality 

of a patient’s medical records is 

entrenched in the fundamental principle 

of the doctor-patient confidentiality 

relationship. This principle finds 

legislative backing in the Indian 

Medical Council (Etiquette and Ethics) 

Regulations 2002. According to IMA, 

a medical practitioner is obliged to 

maintain the utmost secrecy of a 

patient’s medical records in the course of 

his or her practice. “The policy does not 

appear to account for these regulations, 

although it attempts to salvage itself 

with the boilerplate clause of offering 

itself to be read along with, and not 

in contradiction to, laws presently 

applicable in India,” stated IMA. 

Although the policy sets out ‘Privacy 

by Design’ as its guiding principle, IMA 

said, it does not explicitly recognize 

a data principal’s (a person to whom 

the data is related) fundamental right 

to privacy, in as much as according 

legislative recognition of the said right 

The consent mechanism 

described in the NDHB 

document is inadequate. 

Dr R V Asokan 

Secretary-General, IMA 

of the data principal. “Merely because 

the participation of the data principal 

is made voluntary under the policy, the 

information including sensitive personal 

data does not cease to lose its ability to 

violate the data principal’s fundamental 

right to privacy. A patient requiring 

critical and time-sensitive healthcare 

may not be in the right frame of mind 

to review the potential effect of granting 

express consent to the sharing of his or 

her health and medical information for 

the purpose of the policy,” stated IMA. 

It added that subsequent attempts to 

review the consent initially provided 

could be an exercise in futility. 

Chances of misuse high: Experts 

Supporting the views of IMA, advocate 

Shiju P Veetil, Senior Partner, India 

Law LLP, said: “India still doesn’t have 

a data protection law. Rushing to a 

digital health record [database] without 

a statutory data protection framework 

is callous and can have dangerous 

consequences.” 

Existing policies provide for the 

collection of relevant medical data for 

the broader purpose of medical research 

and analysis. In such circumstances, it 

appears that the NDHM policy poses a 

higher risk to sensitive data, in return for 

a repetitive policy exercise. According 

to IMA, the NDHM policy does not 

satisfy the rigours of protecting the 

fundamental right to privacy under 

Article 21 of the constitution of India. 

IMA claimed that the policy strikes a 

discordant note with the existing rules 

and regulations pertaining to medical 

practice in India. 

A data science expert, who does 

not like to be quoted, said: “Medical 

information is of a very sensitive kind. 

Unless and until you have a proper data 

protection law, there are high chances 

for the misuse of the data. Without data 

protection law, it won’t be possible to 

take legal action if the highly sensitive 

data is misused. The government 

says that it is voluntary. But in fact, no 

government scheme is voluntary and it’s 

just for namesake.” 

IMA observed that the 

implementation of the National 

Electronic Health Record (EHR) is a 

complex task, and it requires serious, 

well-thought-out planning backed with 

strong global healthcare informatics 

expertise. It warned that a badly 

designed national EHR system will not 

only be a pain for clinicians but could 

also endanger patients as seen in other 

countries where a subsequent redesign 

involved significant cost. 

Meanwhile, Rahul Matthan, Partner, 

Trilegal, said that having a digital health 

record has several benefits. “It allows 

a doctor to have access to the history 

of the patient and the medicines he or 

she has taken in the past. It also allows 

for getting bigger population-level 

insights. If we had digital records before 

the COVID-19 outbreak, we would have 

been able to get a sense of where the 

disease was coming from as everyone 

is having his health records in electronic 

format. It will also benefit researchers 

and doctors.” However, he said that 

the country may need to build digital 

infrastructure in the rural areas for 

implementing the project. 

While talking about the privacy 

concerns, Matthan said, “The moment 

you go digital, there are privacy concerns 

because right now we are protected by 

the fact that there is no record. Though 

there are privacy risks, we should 

minimize privacy risks and maximize 

benefits.” 


COVID-19 

UPDATES

covid-19 updates 

FIRST ‘HUMAN CHALLENGE’ TRIAL 

ON COVID-19 TO BEGIN IN UK 

Open Orphan plc, a Dublin-based 

commercial clinical-research 

organization, has recently 

announced the signing of a contract 

by its subsidiary hVIVO with the UK 

government to develop a COVID-19 

(SARS-CoV-2) human challenge study 

model. 

In human challenge studies, a 

vaccine candidate that has proven to 

be safe in initial trials is given to a small 

number of carefully selected healthy 

adult volunteers who are then exposed 

to the virus in a safe and controlled 

environment. Medics and scientists then 

closely monitor the effect on volunteers 

24 hours per day to see exactly how the 

vaccine works and to identify any side 

effects. 

The model of development involves 

the manufacture of the challenge virus 

and the first-in-human characterisation 

study for this virus. The characterisation 

study, which is expected to complete 

in May 2021 and will require regulatory 

and ethical approval, enables 

identification of the most appropriate 

dose of the challenge virus for use in 

future human challenge studies, which 

THE RESEARCHERS WILL 

FOCUS ON IDENTIFYING 

THE SMALLEST AMOUNT 

OF THE CORONAVIRUS 

THAT IS NEEDED TO CAUSE 

COVID-19 IN UP TO 90 PAID 

VOLUNTEERS 

play a vital role in helping to develop 

vaccines and antivirals for infectious 

diseases. 

The researchers will focus on 

identifying the smallest amount of the 

coronavirus that is needed to cause 

COVID-19 in up to 90 paid volunteers 

aged 18 to 30. The study will take place 

at a specialist Royal Free Hospital unit in 

London. 

Data from the study are expected 

in May. The use of the challenge model 

to study how vaccines work in humans 

can only begin once data from the 

initial characterisation stage are 

available. 

“First, for the many vaccines still in 

the mid-stages of development, human 

challenge studies may help pick out the 

most promising ones to take forward 

into larger phase 3 trials. Second, for 

vaccines which are in the late stages 

of development and already proven to 

be safe and effective through phase 

3 studies, human challenge studies 

could help us further understand if the 

vaccines prevent transmission as well as 

preventing illness,” Jonathan Van-Tam, 

the UK’s deputy chief medical officer, 

said in a statement. 

The study will take place in worldclass 

clinical facilities at the Royal Free 

specifically designed to contain the virus. 

Highly trained medics and scientists 

will be on hand to carefully examine 

how the virus behaves in the body and 

to ensure volunteer safety. Volunteers 

will be monitored for up to a year after 

participating in the study to ensure their 

long-term well-being. 

Once this first phase is completed, 

researchers will deploy this human 

challenge model which will provide an 

unrivalled opportunity to study closely 

how vaccines work in the body to stop 

COVID-19. 


Russia 

approves 

2nd COVID-19 

vaccine 

Russia has approved 

the new coronavirus 

vaccine developed by 

Siberian biotech company 

Novosibirsk’s Vektor [State 

Virology and Biotechnology 

Center], President Vladimir 

Putin has announced. 

The peptide-based 

vaccine named EpiVacCorona 

has been tested among 100 

volunteers in the placebocontrolled 

human trials 

which lasted for more than 

two months. Volunteers 

aged between 18 and 60 

years were included in the 

study. 

Unlike the first Russian 

vaccine “Sputnik V”, which 

is a vector vaccine, the new 

vaccine was created on the 

basis of synthetic platforms. 

EpiVacCorona is a peptide 

vaccine, that consists of 

artificially synthesized short 

fragments of viral peptides 

as antigens, which the 

immune system learns and 

subsequently recognizes and 

neutralizes the virus. 

The scientists have yet 

to publish the results of the 

study. 

SYNTHETIC 

EPIVAC 

Russia's new COVID-19 

vaccine has been created 

on the basis of synthetic 

platforms, unlike the first. 

2months-long placebocontrolled 

trials on the 

experimental vaccine 

100 

volunteers participated 

in the human trials 

Bharat Bio and 

Washington Univ 

to develop an 

intranasal vaccine 

Bharat Biotech has inked a licensing 

agreement with Washington University 

School of Medicine in St. Louis for a novel 

chimp-adenovirus, single-dose intranasal 

vaccine for COVID-19. 

The company owns the rights to distribute 

the vaccine in all markets except the USA, 

Japan and Europe. 

The phase I trials will take place in Saint 

Louis University’s Vaccine & Treatment 

Evaluation Unit. Bharat Biotech will pursue 

further stages of clinical trials in India and 

undertake large scale manufacture of the 

vaccine at its GMP facility located in Genome 

Valley, Hyderabad, upon obtaining the required 

regulatory approval. 

“An intranasal vaccine will not only be 

simple to administer but reduce the use of 

medical consumables such as needles, syringes, 

etc., significantly impacting the overall cost 

of a vaccination drive,” said Dr Krishna Ella, 

chairman and managing director of Bharat 

Biotech, in a statement. 

This intranasal vaccine candidate has 

shown unprecedented levels of protection in 

mice studies; the technology and data having 

been recently published in Cell and in an 

editorial in Nature. 

This vaccine expands Bharat Bio’s 

portfolio of vaccines that are currently being 

developed and are in various stages of clinical 

development including Covaxin which is 

currently in phase II human clinical trials in 

India. 

Sanofi and 

Translate report 

preclinical data 

Sanofi Pasteur and Translate Bio 

announced the preclinical results 

for MRT5500, an mRNA-based vaccine 

candidate that demonstrated a 

favourable immune response profile 

against SARS-CoV-2. 

A phase 1/2 clinical trial is 

anticipated to begin in the fourth 

quarter of 2020. 

In mice, four dose levels were 

assessed at 0.2, 1, 5 and 10 µg per 

dose using a two-dose vaccination 

schedule, administered three weeks 

apart. MRT5500 induced dosedependent 

levels of binding antibodies 

and neutralising antibodies specific to 

the SARS-CoV-2 spike protein. 100% 

seroconversion was observed at all dose 

levels after one administration, and a 

further increase in titers was observed 

following a second administration. 

Neutralizing antibody titers were 

observed across all dose levels after 

receiving the two-dose-administration 

regimen. In the higher dose groups (5 

µg, 10 µg), titers were detected after 

one administration of MRT5500 and 

were more pronounced after the second 

administration. 

In non-human primates (NHPs), 

three dose levels were assessed at 15, 

45 and 135 µg per dose using a twoadministration 

vaccination schedule, 

three weeks apart. The potency of 

MRT5500 was assessed by two types 

of neutralization assays: pseudovirus 

neutralization and micro-neutralization. 


THE HUNT FOR A VACCINE 

Researchers around the world are working at a breakneck 

pace to test different types of vaccines to stop COVID-19. 

PHASE 1 

35 

vaccines 

vaccines 

testing safety 

and dosage 

PHASE 2 

14 

in 

vaccines 

expanded 

safety trials 

PHASE 3 

11 

in 

vaccines 

large-scale 

efficacy 

tests 

LIMITED 

6 

Vaccines 

approved for 

early or 

ltd use 

APPROVED 

0 

approved 

for use 

J&J halts 

vaccine study 

Johnson & Johnson has halted the study 

of its experimental COVID-19 vaccine 

candidate due to an unexplained illness in 

a study participant. 

A document sent to outside 

researchers running the 60,000-patient 

clinical trial states that a “pausing rule” 

has been met, that the online system used 

to enroll patients in the study has been 

closed. 

J&J’s vaccine is a single-dose COVID-19 

vaccine in phase 3 trials. 

In a statement on the decision to 

pause the trials J&J said: “It’s important 

to have all the facts before we share 

additional information.” It added that it 

was not always immediately apparent 

whether a participant received the vaccine 

or a placebo. 

The participant’s adverse reaction 

was being reviewed by an independent 

data safety monitoring board and the 

company’s doctors, the New Jersey-based 

drugmaker said. It added that serious 

adverse events were not uncommon in 

clinical trials, and that their frequency 

was expected to increase as trial sizes 

expanded. J&J said that while it normally 

communicates clinical holds to the public, 

it does not usually inform the public of 

study pauses. 

J&J is at present studying its vaccine 

candidate in one- and two-dose regimens. 

It is unclear which trial the participant was 

enlisted in. 

J&J is the second company to have 

halted COVID-19 vaccine trials in recent 

months. AstraZeneca stopped its trial in 

September when at least one participant 

developed unexplained neurological 

symptoms. 

EMA panel begins first rolling 

review of AstraZeneca’s 

COVID-19 vaccine 

EMA’s human medicines 

committee (CHMP) has started 

the first ‘rolling review’ by evaluating 

the first batch of nonclinical data of 

the COVID-19 vaccine developed by 

AstraZeneca in collaboration with 

the University of Oxford. 

The vaccine is made up of an 

adenovirus that has been modified 

to contain the gene for making the 

SARS-CoV-2 spike protein. 

A rolling review is one of the 

regulatory tools that the agency 

uses to speed up the assessment 

of a promising medicine or vaccine 

during a public health emergency. 

Normally, all data on a medicine’s 

effectiveness, safety and quality 

and all required documents must 

be submitted at the start of the 

evaluation in a formal application for 

marketing authorization. In the case 

of a rolling review, the CHMP reviews 

data as they become available from 

ongoing studies, before deciding 

that sufficient data are available and 

that a formal application should be 

submitted by the company. 

The CHMP’s decision to start 

the rolling review of the vaccine is 

based on preliminary results from 

non-clinical and early clinical studies 

suggesting that the vaccine triggers 

the production of antibodies and T 

cells that target the virus. 

Results from large-scale clinical 

trials will be assessed in later rolling 

review cycles. All the available 

data on the safety of the vaccine 

emerging from these studies, as well 

as data on its quality, will also be 

reviewed. 

The rolling review will continue 

until enough evidence is available 

to support a formal marketing 

authorization application. 

The rolling review process 

has been used previously in the 

assessment of COVID-19 medicine, 

remdesivir. 


GRIFOLS BEGINS CLINICAL TRIAL 

OF HYPERIMMUNE GLOBULIN 

Grifols has started a 

randomized controlled 

clinical trial on anti-SARS- 

CoV-2 hyperimmune globulin 

to test its safety, efficacy and 

tolerability. 

This medicine provides a high 

and consistent concentration of 

purified neutralizing antibodies 

and could be used for both 

prevention and treatment of the 

disease. The study is sponsored 

and funded by the National 

Institute of Allergy and Infectious 

Diseases (NIAID), part of the 

US National Institutes of 

Health (NIH). 

The study is to determine 

if giving the anti-coronavirus 

hyperimmune globulin when 

COVID-19 symptoms first appear, 

before a person’s immune system 

makes a protective immune 

response on its own, could 

augment the natural antibody 

response to SARS-CoV-2, thereby 

reducing the risk of more serious 

illness and death. 

This is the first international 

multicentre clinical trial of an 

anti-SARS-CoV-2 hyperimmune 

globulin, which is randomized 

double-blind, placebo-controlled 

and adaptive. Patients will 

receive either the anti-SARS- 

CoV-2 hyperimmune globulin 

and remdesivir, or remdesivir plus 

placebo. 

The phase 3 trial, called 

Inpatient Treatment with Anti- 

Coronavirus Immunoglobulin 

(ITAC), will include 500 

hospitalised adults with COVID-19 

in up to 58 hospitals covering 18 

countries including the US and 

Spain. For the trial Grifols has 

collected convalescent plasma 

from healthy recovered COVID-19 

donors, in the US using its plasmacentre 

network and in Spain 

through a collaboration with blood 

banks. 

The anti-SARS-CoV-2 

hyperimmune globulin is one of 

the treatments for patients whose 

respiratory symptoms require 

hospitalisation but not intensive 

care. 

Grifols is also leading studies 

with alpha-1 antitrypsin and 

immunoglobulins for hospitalized 

patients with different disease 

progression, or requiring intensive 

care, in the US and Spain. 

Iontas, FairJourney discover antibodies 

Iontas and FairJourney Biologics have 

announced the discovery of potent 

SARS-CoV2 neutralizing antibodies as 

potential therapeutics for COVID-19. 

The newly-identified panel of 

antibodies has been shown to block 

infection at doses as low as 20pM 

in pseudoviral assays and 100pM in 

live coronavirus assays, surpassing or 

matching the best antibodies reported. 

This viral neutralization efficiency was 

independently verified by the National 

Institute for Biological Standards and 

Control (NIBSC). 

In two months, hundreds of virusneutralizing 

antibodies were isolated 

and characterized from the blood of 

donors who were recovering from 

COVID-19. A final panel of 15 potent 

SARS-CoV-2 neutralizing antibodies 

was then selected, which have 

biophysical properties well suited for 

downstream drug development, such 

as low polyreactivity and resistance 

to aggregation. This reduces the risk 

of future clinical development and 

manufacturing. 


US FDA 

nod to start 

phase 2 

study of 

FSD201 

The US FDA has authorised the initiation of a phase 

2 study for the use of FSD201 (ultramicronized 

palmitoylethanolamide, or ultramicronized PEA) to treat 

COVID-19, FSD Pharma said. 

The FSD201 COVID-19 trial is a randomised, controlled, 

double-blind, multicentre study, conducted on 352 patients 

to assess the efficacy and safety of FSD201 dosed at 600mg 

or 1200mg twice-daily, together with the standard of care 

(SOC) compared to SOC alone in hospitalized patients with 

documented COVID-19 disease. Eligible patients will present 

symptoms consistent with influenza/coronavirus signs (fever, 

dry cough, malaise, difficulty breathing) and newly documented 

positive COVID-19 disease. 

The primary objective of the FSD201 COVID-19 Trial is to 

determine whether FSD201 plus SOC provides a significant 

improvement in the clinical status of patients (e.g., shorter time 

to symptom relief). 

Secondary objectives of the FSD201 COVID-19 Trial include 

determining whether FSD201 plus SOC demonstrates additional 

benefit in terms of safety, objective assessments such as 

length of time to normalization of fever, length of time to the 

improvement of oxygen saturation and length of time to clinical 

progression, including the time to mechanical ventilation or 

hospitalization, and length of hospital stay. The exploratory 

endpoint is cytokine clearance as measured by Enzyme- 

Linked Immunosorbent Assay (ELISA). 

The treatment period for patients in the FSD201 

COVID-19 trial is 14 days and the primary 

endpoint is determined at 28 days. 

Regeneron’s REGN-COV2 antibody cocktail cuts viral levels 

Regeneron Pharmaceuticals Inc 

announced the first data from a 

descriptive analysis of a seamless phase 

1/2/3 trial of its investigational antibody 

cocktail REGN-COV2 showing it reduced 

viral load and the time to alleviate 

symptoms in non-hospitalised patients 

with COVID-19. REGN-COV2 also showed 

positive trends in reducing medical 

visits. 

The ongoing, randomized, doubleblind 

trial measures the effect of adding 

REGN-COV2 to usual standard-ofcare, 

compared to adding placebo to 

standard-of-care. 

The descriptive analysis included the 

first 275 patients enrolled in the trial 

and was designed to evaluate anti-viral 

activity with REGN-COV2 and identify 

patients most likely to benefit from 

treatment; the next cohort, which could 

be used to rapidly and prospectively 

confirm these results, has already been 

enrolled. 

Patients in the trial were 

randomized 1:1:1 to receive a one-time 

infusion of 8 grams of REGN-COV2 (high 

dose), 2.4 grams of REGN-COV2 

(low dose) or placebo. All patients 

entering the trial had laboratoryconfirmed 

COVID-19 that was 

being treated in the outpatient 

setting. Patients were prospectively 

characterized prior to treatment by 

serology tests to see if they had 

already generated antiviral antibodies 

on their own and were classified 

as seronegative or seropositive. 

Approximately 45% of patients were 

seropositive, 41% were seronegative 

and 14% were categorized as “other” 

due to unclear or unknown serology 

status. 

THE ANTIBODY 

The anti-viral activity with 

REGN-COV2 was analysed in 

275 patients enrolled in the trial 

INFUSION 

45% 41% 14% 

among them were 

found seropositive 

were 

seronegative 

were categorised 

as "other" 


AstraZeneca commences 

phase 3 studies on longacting 

antibody combo 

AstraZeneca’s long-acting antibody 

(LAAB) combination, AZD7442, will 

advance into two phase III clinical trials 

in more than 6,000 participants at sites 

in and outside the US. The LAABs have 

been engineered with AstraZeneca’s 

proprietary half-life extension 

technology to increase the durability 

of the therapy for six to 12 months 

following a single administration. The 

combination of two LAABs is also 

designed to reduce the risk of resistance 

developed by the SARS-CoV-2 virus. 

The company has received the 

support of around $486 million from 

the US government for the development 

and supply of AZD7442 under an 

agreement with the Biomedical 

Advanced Research and Development 

Authority (BARDA), part of the Office of 

the Assistant Secretary for Preparedness 

and Response at the US Department 

of Health and Human Services, and the 

Department of Defense Joint Program 

Executive Office for Chemical, Biological, 

Radiological and Nuclear Defense. 

One trial will evaluate the safety and 

efficacy of AZD7442 to prevent infection 

for up to 12 months, in approximately 

5,000 participants. The second trial will 

evaluate post-exposure prophylaxis and 

pre-emptive treatment in approximately 

1,100 participants. 

AstraZeneca is planning additional 

trials to evaluate AZD7442 in 

approximately 4,000 patients for the 

treatment of COVID-19. 

AZD7442 is a combination of two 

LAABs derived from convalescent 

patients after SARS-CoV-2 infection. 

Discovered by Vanderbilt University 

Medical Center and licensed to 

AstraZeneca in June 2020, the LAABs 

were optimised by AstraZeneca with 

half-life extension and reduced Fc 

receptor binding. The half-life extended 

LAABs should afford six to 12 months 

of protection from COVID-19. The 

reduced Fc receptor binding aims 

to minimise the risk of antibodydependent 

enhancement of disease - a 

phenomenon in which virus-specific 

antibodies promote, rather than inhibit, 

infection and/or disease. 

Eli Lilly puts 

antibody 

therapy on hold 

over safety 

concerns 

The late-stage clinical trials of the 

monoclonal antibody therapy 

(mAb) bamlanivimab (LYCoV555) 

for COVID-19 conducted by the US 

pharmaceutical company Eli Lilly 

has been recently halted by the 

health regulators over potential 

safety concerns. 

LY-CoV555 developed by Eli 

Lilly and AbCellera is a potent, 

neutralizing IgG1 monoclonal 

antibody (mAb) directed against the 

spike protein of SARS-CoV-2. It is 

designed to block viral attachment 

and entry into human cells, thus 

neutralizing the virus, potentially 

preventing and treating COVID-19. 

The ACTIV-3 trial had enrolled 

326 mild to moderate COVID-19 

patients who were administered 

with an intravenous infusion of the 

neutralizing IgG1 mAb LY-CoV555 

or placebo along with antiviral drug 

remdesivir in both the arms. The 

independent Data Safety Monitoring 

Board (DSMB) found that after 

five days of treatment, the group 

of patients who had received the 

antibodies showed a different 

“clinical status” than the group 

who had received a saline placebo 

— a difference that crossed a 

predetermined threshold for safety. 


LabCor launches 

IgG test to assess 

effectiveness of 

COVID-19 vaccines 

LabCorp announced the launch of 

a test that provides a quantitative 

measurement of an individual’s SARS- 

CoV-2 IgG antibodies. 

Cov2Quant IgG test, which is 

available only for use in clinical trials and 

research, was developed to specifically 

detect and quantify antibodies to SARS- 

CoV-2, the virus that causes COVID-19. 

Other COVID-19 antibody tests available 

in the market are qualitative and detect 

the presence of antibodies, but do not 

provide information on the individual’s 

antibody levels, LabCorp said. 

The test is also currently being 

utilized by the Centers for Disease 

Control and Prevention (CDC) for 

SARS-CoV-2 seroprevalence studies 

to understand the level of antibodies 

produced through natural exposure and 

infection with the virus. 

Eurofins’ home 

COVID-19 nasal PCR 

test receives EUA 

An Emergency Use Authorization 

(EUA) from the US FDA has been 

granted to their at-home COVID-19 nasal 

PCR test, Eurofins US Clinical Diagnostics 

said. 

The EUA authorized self-collection 

kit gives consumers a minimally invasive, 

convenient and quick option to test from 

the comfort of their home. 

Results are provided 

via email within 24 

hours of sample 

receipt. 

Eurofins’ 

infectious 

disease centre 

for excellence, 

Viracor, 

developed the test 

based on its highly 

sensitive, FDA EUAauthorized 

SARS- 

CoV-2 RT-PCR 

assay. 

ROCHE INTRODUCES 

LABORATORY SARS-COV-2 

ANTIGEN TEST 

Roche will launch a high-volume 

SARS-CoV-2 antigen test as an 

aid in the diagnosis of SARS- 

CoV-2 infection. The test is planned 

to be made available at the end of 

2020 for markets accepting the CE 

mark. The Swiss drug major also 

intends to file for Emergency Use 

Authorisation (EUA) from the US FDA. 

The Elecsys SARS-CoV-2 Antigen 

test is a laboratory immunoassay for 

the in vitro qualitative detection of 

the nucleocapsid antigen of SARS- 

CoV-2. The test is performed by 

healthcare professionals and uses 

nasopharyngeal or oropharyngeal 

swab samples from patients with 

signs and symptoms suggestive 

of COVID-19 or people with either 

known or suspected exposure to 

SARS-CoV-2. 

The Elecsys SARS-CoV-2 Antigen 

immunoassay runs on all cobas e 

immunochemistry analyzers. These 

fully automated systems can provide 

test results in 18 minutes for a single 

test, with a throughput of up to 300 

tests per hour from a single analyzer. 

A laboratory-based automated 

antigen assay allows for cost and 

error reduction due to the removal 

of manual handling as well as fast 

turn-around times and high-test 

throughput. 

300 

anitgen tests can be 

done per hour in 

a single analyser 

22 / FUTURE 

MEDICINE / November 2020

US FDA grants EUA 

for Abbott’s IgM 

lab-based serology 

test 

Abbott said that the US FDA issued 

Emergency Use Authorization 

(EUA) for the company’s AdviseDx 

SARS-CoV-2 IgM lab-based serology 

test for use on the Architect and 

Alinity platforms. 

Abbott first developed an IgG 

blood test, which often is the antibody 

that is longer lasting in the body after 

infection. 

The IgM antibody, in comparison, 

is most useful for determining a 

recent infection as these antibodies 

become undetectable weeks to 

months following infection. 

Abbott’s data demonstrated 

99.56% specificity and 95.00% 

sensitivity for patients tested 15 days 

after symptom onset. 

US FDA grants EUA 

to ZEUS’s IgG test 

system 

ZEUS Scientific announced that 

it has received Emergency Use 

Authorization (EUA) from the US FDA 

for its in vitro ELISA diagnostic test 

for the qualitative detection of IgG 

antibodies to the SARS-CoV-2 virus in 

human serum and plasma. 

Using EUA approved RT-PCR 

assays as the reference method, the 

ZEUS ELISA SARS-CoV-2 IgG Test 

System demonstrated 100% positive 

agreement and 99.1% negative 

agreement. The average days 

between the PCR test result and the 

specimen draw was 15.97 days, the 

earliest being 3 days. 

LabCorp’s COVID-19 

molecular test 

wins EUA 

LabCorp announced that its 

commercial laboratory will receive 

an Emergency Use Authorization 

(EUA) from the US FDA for a new, 

high-throughput method that uses 

heat and technology to extract RNA 

from samples collected for COVID-19 

molecular testing. 

The innovative heat extraction 

process, which has comparable 

sensitivity to current extraction 

methods, traps viral particles, 

eliminating the need for RNA 

extraction reagents to capture 

and concentrate viral nucleic acid. 

This substantially improves testing 

efficiency and decreases LabCorp’s 

reliance on testing supplies - 

streamlining resources and further 

reducing the time needed to complete 

and report results for molecular tests. 

Thermo Fisher launches 2 new antibody tests 

Thermo Fisher Scientific Inc 

introduced two new SARS-CoV-2 

antibody tests: the Thermo Scientific 

OmniPATH COVID-19 Total Antibody 

ELISA test, and the Thermo Scientific 

EliA SARS-CoV-2-Sp1 IgG test. 

The OmniPATH COVID-19 Total 

Antibody ELISA test, developed in 

conjunction with the Mayo Clinic 

and WuXi Diagnostics as previously 

announced, has been granted 

Emergency Use Authorization (EUA) 

from the US FDA for the qualitative 

detection of total antibodies to 

SARS-CoV-2, including IgM, IgA and 

IgG. 

The EliA SARS-CoV-2-Sp1 IgG 

test is commercially available in 

accordance with the FDA’s 

“Policy for Coronavirus Disease-2019 

Tests During the Public Health 

Emergency (Revised)”. The EUA is 

currently under review by the 

FDA. The test is designed for 

automated processing of up to 

60 results per hour on the 

Thermo Scientific Phadia 250 

instrument. 

Both of these new antibody 

tests are designed to meet the need 

for open ELISA and automated 

workflows, Thermo Fisher said. 


AUGUST 2018/ FUTURE MEDICINE / 85

column 

trialomics 

Prophylactic therapy 

trials for COVID-19 

Designing prophylactic RCTs for COVID-19 requires 

in-depth consideration of many issues 

DR ARUN BHATT 

Writer is a consultant 

on clinical research & 

development from 

Mumbai. 

arun_dbhatt@hotmail.com 

The COVID-19 pandemic is a new and 

serious malady in search of effective 

therapies. Randomised clinical trials 

(RCTs) have been conducted to gauge the 

efficacy of dexamethasone and remdesivir. 

But SARS-CoV-2’s infectivity underscores the 

need for prophylactic treatments which can 

reduce the chances of transmission of the 

virus and/or prevent the development of the 

disease. In the absence of vaccines, many 

potential prophylactic therapies are being 

used in trials. However, prophylactic RCTs for 

a pandemic require in-depth consideration of 

many design issues in the planning stage. 

Prophylactic RCT could be 1) Pre-exposure 

trials in persons at high risk for SARS-CoV-2 

exposure with no symptoms, e.g. health 

care workers (HCW), or 2) Post-exposure 

trials in HCW or household contacts with no 

symptoms and with a documented exposure 

to a definite or clinically presumed case. 

Participants are enrolled only if they do not 

have a previously confirmed diagnosis of 

COVID-19. 

It would not be particularly useful to 

select participants from the community 

population who are at a low risk of exposure 

to the pandemic or of developing COVID-19 

and in whom the specificity of reported 

symptoms are low and the time of exposure 

to the virus is uncertain. 

The selection of therapy is based 

on potential mechanisms: e.g. antiviral 

activity and immunomodulation. In Oxford 

COPCOV study in HCW, chloroquine (CQ) 

/ hydroxychloroquine (HCQ) was used 

because of its significant antiviral activity 

against SARS-CoV-2 in cell culture, and the 

wide human experience of its use in malaria 

and rheumatoid arthritis. HCQ is given at a 

loading dose of 10mg base /kg on the first 

day, followed by 5mg base /kg for 90 days. 

In this study, the primary endpoint — the 

occurrence of RT-PCR-confirmed SARS- 

CoV-2 infection (with or without symptoms) 

would be compared between CQ/HCQ and 

placebo control. Serology antibody estimation 

at study enrollment would be useful in the 

ascertainment of the efficacy endpoint, based 

on a combination of observed symptoms of 

COVID-19 and RT-PCR tests. 

Several herbal prophylactic studies 

use immunomodulators such as Tinospora 

cordifolia. Most trials conducted in low-risk 

healthy community populations are open 

comparative studies between those taking 

the drugs and those not taking the drugs. 

The efficacy endpoint — incidence of clinical 

symptoms without confirmation by RT-PCR 

— puts a question mark on the validity of the 

results. 

The sample size in prophylactic trials 

should be large enough to provide reasonable 

evidence of the efficacy and safety of the 

intervention. The Oxford trial plans to recruit 

20,000 participants – 10,000 each on CQ 

and HCQ and 20,000 on marching placebo, 

based on the assumption of 3% incidence 

of symptomatic COVID-19 during the trial 

period and the likelihood of the reduction of 

incidence by 23% in the CQ/HCQ group. 

Prophylactic trials in a large number of 

participants need robust oversight and efficient 

project management of multiple clinical trial 

sites over several months. Critical processes 

– such as the ethics committee approval, 

informed consent, training, randomisation, 

blinding, supervised drug administration, 

compliance check by tablet count and 

drug levels, mobile app-based reporting 

of symptoms and adverse events, monthly 

follow-up to assess critical data on efficacy 

and safety, nose and throat swab for RT-PCR 

and antibody estimation - require meticulous 

planning and team effort to ensure the quality 

and validity of prophylactic trials. 


cover story 

WHITHER 

HERD 

IMMUNITY? 

India’s seroprevalence findings suggest that 

the country is nowhere close to achieving herd immunity 


S HARACHAND 

They were supposed to be further proof 

that India is inching closer towards herd 

immunity against COVID-19, but the 

results of India’s latest serosurveys have turned 

out to be anything but. 

Serosurveillance, considered the gold 

standard for measuring population immunity 

arising out of past infection or vaccination, can 

provide crucial insights into progression of a 

pandemic, its current prevalence level and its 

likely trajectory for the future. 

Many were, therefore, hoping that the large 

number of serosurveys conducted in various 

parts of India in the August-September period 

would reveal how close the country is towards 

achieving herd immunity. 

A distant dream? 

Data from the most recent nationwide survey 

carried out by the Indian Council of Medical 

Research (ICMR) show that only a fraction of 

the general population is seropositive for the 

SARS-CoV-2 infection. At 7%, the figure fell 

way below the threshold needed for reaching 

herd immunity. According to most experts, viral 

transmission does not slow down until at least 


In mid-May, when India’s centrally 

imposed lockdown restrictions began 

to ease up, the Indian Council of Medical 

Research (ICMR) launched a nationwide 

cross-sectional serosurvey in over 26,000 

individuals in 70 districts. The survey 

included only the containment zones of the 

10 cities reporting the highest number of 

cases as of April 25. 

The long-awaited results of the initial 

study — published in the Indian Journal of 

Medical Research on September 10, 2020 

— arrived at the conclusion that the national 

seroprevalence rate was only 0.73% among 

the general population, excluding the 

hotspots of 10 cities. 

The second national serosurvey, whose 

findings were published at the end of 

September, revealed that seropositivity 

levels had reached 7%. Despite the 10- 

fold jump in the rates, it highlighted 

the continued vulnerability of a massive 

seronegative population base. 

The objective of the second study, 

which was carried out among the 29,082 

people across 70 districts in 21 states 

between August 17 and September 22, was 

to estimate the prevalence of SARS-CoV-2 

infection among individuals aged 10 years 

and above, ICMR said. 

Around 6.6% of individuals aged 10 

and above and 7.1 percent of the adult 

population aged 18 and above showed 

HIGH INFECTION NUMBERS, 

BUT LOW IN PREVALENCE 

evidence of past exposure to the virus. 

At 8.2%, the infection prevalence was 

found nearly double in urban non-slums 

compared to rural areas (4.4 percent). 

The infection rate was the highest at 15.6 

percent in urban slums. 

The country-wide prevalence of the 

THE SURVEYS FOUND THE 

INFECTION PREVALENCE IS 

NEARLY DOUBLE IN URBAN 

NON-SLUMS COMPARED TO 

RURAL AREAS. THE RATE OF 

INFECTION IS THE HIGHEST IN 

URBAN SLUMS 

virus was similar to that seen in the United 

States at the time, which was around 9.3%. 

Brazil and Spain had a prevalence of 2.8% 

and 4.6%, the ICMR said. 

City surveys 

In May, the country’s apex body governing 

biomedical research advised states to 

conduct periodic serosurveys to measure 

coronavirus exposure in the population 

using the IgG ELISA test. 

Municipal corporations of major cities 

in India, including Delhi, Mumbai and 

Ahmedabad, released the results of the 

COVID-19 seroprevalence surveys that they 

had conducted in association with research 

institutes. 

The data from these surveys provide us 

some insight into the infection prevalence in 

urban Indian populations. 

National Centre for Disease Control 

(NCDC), under the health ministry, in 

collaboration with the Delhi government 

carried out a community-based crosssectional 

serosurvey in all the 11 districts of 

Delhi between June 27 and July 10. 

After analysing 21,387 sera samples, 

the study found that average infection 

prevalence across Delhi from mid-June to 

the third week of the month was 22.86 

percent. This indicated that about 4.6 

million individuals out of over 20 million 

population in Delhi were infected, even 

though the official tally ranged from 43,000 

to 82,000 during that period. 

Though smaller in size, the Mumbai 

serosurvey was undertaken by a joint 

venture between Tata Institute of 

Fundamental Research (TIFR), Mumbai; 

Translational Health Science and Technology 

Institute (THSTI), Faridabad, Haryana; 

University of Chicago, United States; Duke 

SURVEY JIGSAW 

While the average national 

seropositivity is very low, 

urban centres report very 

high prevalence of 

SARS-CoV-2 infection 

India 

7% 

Mumbai 

50% 

New Delhi 

29% 

60 percent of the population is infected. 

The “revelation” that the great majority 

of the 1.3 billion-strong Indian population 

is still susceptible to the infection came as 

nothing less than a shock to those waiting 

for redemption from the pandemic by way 

of ‘herd immunity’. 

They found the data at odds with the 

steady surge of daily case counts seen through early October 

which saw the country emerge as the world hotspot for 

COVID-19. 

“The entire country is looking forward to achieving herd 

immunity,” said Dr Behram Pardiwala, Director, Internal 

Medicine and Academics, Wockhardt Hospitals, South 

Mumbai, echoing a widely held sentiment. “Once, herd 

immunity is reached, the pandemic will surely end.” 


University, North Carolina, US; ATE Chandra 

Foundation, a Mumbai-based philanthropic 

organisation; Kasturba Hospital, Mumbai; 

and IDFC Institute, a Mumbai-based public 

policy think tank. 

The study has estimated an average 

prevalence of 56.5 percent in slums and 

15.5 percent in non-slums in the three 

wards selected. Assuming that 42 percent 

of Mumbai’s population lives in slums, this 

works out to an overall seroprevalence 

rate of about 33 percent for the entire city, 

which is significantly higher than the value 

of about 23 percent found for Delhi. 

On the basis of these results, the study 

inferred that asymptomatic infections are 

likely to constitute a high fraction of the 

total infections, like in the case of Delhi. 

The Ahmedabad Municipal Corporation 

(AMC) claimed that the serosurvey 

conducted in the city was the world’s 

largest, but it released only as much 

information about the results as the Delhi 

survey. According to the AMC press release, 

the survey was conducted from June 16 

to July 11, with 30,054 samples collected 

among the seven zones of the city. It found 

that about 16.7% of the samples returned 

positive for antibodies. The city has a 

population of around 6.3 million. 

In these surveys, average prevalence 

numbers ranged from 50% in Mumbai to 

29% in New Delhi, 32% in Chennai and 

7.8% in Indore. Surveys in other cities are 

underway. 

These numbers roughly suggest 

that about one out of every four or five 

individuals in the major cities have been 

infected. Yet, this is still far off from what is 

required for herd immunity to set in. 

Chennai 

32% 

Indore 

7.8% 

Repeated surveys in the cities of 

Mumbai and Delhi came out with results 

that seem at odds with early findings. Data 

from the second survey in Mumbai, for 

example, showed a 12% fall in the level of 

exposure to the virus in slum areas. The 

Brihanmumbai Municipal Corporation’s 


second round of survey in August, which 

covered 5,384 people in three wards, found 

that 45% of the people residing in the city’s 

slums were exposed to the coronavirus, 

compared to the nearly 57% recorded in 

the first survey in July. But for non-slum 

areas, seroprevalence rose to 18% from the 

16% earlier. 

The surveys also showed that levels of 

seroprevalence varies substantially from one 

locality to another within the city. 

Similar trends were also seen in the 

third survey carried out in Delhi, which 

found seroprevalence down by almost 4%. 

Flaws in methodology; 

erroneous sampling 

Critics have pointed to several flaws in the 

sampling design and methodology of these 

surveys, while researchers explain that the 

discrepancies may be technical in nature as 

an entirely different set of people may have 

been surveyed the second time. 

Another, more worrying possibility 

is that of a rapid drop in SARS-CoV-2 

antibodies soon after recovery. “As time 

passes, antibodies to SARS-CoV-2 are 

known to decline rapidly,” says Dr Lancelot 

Pinto, Consultant Respirologist, P D Hinduja 

National Hospital and Medical Research 

Centre, Mumbai. 

He pointed to a recent study that 

reported that concentrations of antibodies 

in a recovered individual are halved roughly 

every 36 days. This would imply that unless 

MUMBAI: 

FALL IN NUMBERS 

Subsequent surveys 

revealed a significant 

drop in seroprevalence in 

Mumbai slums 

57% 45% 

July 

August 

“Any definitive 

conclusion 

on SARS-CoV-2 

immunity needs 

more evidence” 

Dr Chandrakant Lahariya is a medical 

doctor and a leading public policy and 

health systems expert. He has received 

advanced training in epidemiology, vaccinology, 

immunology and public health. In the last 

15 years, he has worked closely with India’s 

topmost health-policy makers to develop 

and implement several health policies and 

programmes at both the union and state 

levels. He is the youngest fellow ever elected to 

the Indian Public Health Association (IPHA). 

In an interaction with FM, Dr Lahariya 

points out that while serosurveys remain the 

best tool to fathom the level of population 

immunity due to past infection, it is important 

that the results of these studies be interpreted 

carefully, factoring in their context and 

limitations. 

Edited excerpts: 

Data from metros like Mumbai and Delhi 

show that seroprevalence is declining in 

consecutive surveys across population 

groups. Is the disparity a result of different 

methodological approaches or is it indicative 

of a deeper problem specific to SARS-CoV-2, 

such as quickly vanishing antibodies? 

We really cannot say that the trend 

is declining till we see such a pattern in 

comparable surveys and we have the 

confidence intervals (CI) along with the point 

prevalence, which are being reported. The 

findings of the third serosurvey in Delhi are 

not comparable with the previous two, and 

definitely, the methods are much more robust. 

As for serosurveys in Mumbai, we don’t really 

know the CI. However, at least the difference 

from 16% to 18% is unlikely to be statistically 

significant. 

It is too early to become concerned about 

the level of antibodies. There is evidence that 

even when there are no detectable antibodies, 

the person could be protected. In addition, 

the antibody response after vaccination is 


far superior to antibody response after 

natural infection. Therefore, any definitive 

conclusion needs more evidence, which is 

emerging with every passing day. 

Critics argue that the serosurvey 

reports conducted in India may not be 

representative because they are not 

conducted under a uniform guideline 

nor are the sampling methods/sizes 

statistically significant. What is your 

comment? 

For a country of the size of India, no 

matter what sample size and approach is 

used, it will always have some limitations. 

That is true for serosurvey at the national, 

state and district levels. An ideal, not 

necessarily the best, approach would be 

to test the entire population, which is 

neither feasible and nor required. Clearly, 

serosurveys are the best alternative. The 

role of the scientific community is to 

minimise those limitations. It is important 

that the limitations are acknowledged, and 

we keep improving the methods adopted. 

Most important is that interpretations are 

An ideal, not necessarily 

the best, approach 

would be to test the 

entire population, which 

is neither feasible and 

nor required. Clearly, 

serosurveys are the best 

alternative. The role of 

the scientific community 

is to minimise those 

limitations. It is important 

that the limitations are 

acknowledged, and 

we keep improving the 

methods adopted. 

Dr Chandrakant Lahariya 

done carefully, factoring in the context and 

limitations. 

The case-to-infection ratio has also 

fallen significantly; according to most 

recent serosurveys. What does this 

suggest? Is the community spread of the 

virus slower than predicted? 

The falling case-to-infection ratio is a 

reflection of the improved implementation 

of the test, trace and isolate strategy. 

COVID-19 testing services have increased 

across the country. Tracing efforts have 

improved and people are also more 

aware, and volunteer for testing. For the 

spread of the virus, there is no expected 

speed or rate, and the only direction we 

want is downward. 

Virologists question the sensitivity 

and specificity of most of the widely 

deployed antibody tests. How does 

a high percentage of false positives 

or negatives impact the results of a 

survey? 

The antibody kits which have been 

used for serosurvey have fairly high 

sensitivity and specificity. Specific 

approaches have been followed to further 

enhance these parameters within the 

serosurvey. In any case, these reflect past 

infections, and therefore, while sensitivity 

and specificity are important, these 

are not everything. While it results in 

limitations in stand-alone surveys; repeat 

surveys provide very useful guidance on 

trends. 

Can we make serological testing the 

only way to assess the immunity level of 

an individual, particularly at this point of 

time when the herd immunity threshold 

for SARS-CoV-2 is still being debated? 

Everything in COVID-19 provides a part 

of the answer and no single approach 

is enough for a complete answer. There 

are many unknowns, such as what is the 

protective level of antibodies, how long 

the immunity lasts and what proportion 

of infected individuals develop detectable 

levels of antibodies. Our knowledge and 

understanding are getting better with 

every passing day. In this backdrop, we 

should use all the approaches at hand 

- serosurveys, antibody levels, immunity 

research and epidemiological data - to 

measure immunity levels. One of the 

impacts of the pandemic has been that 

we have learnt to use various tools across 

specialties — including clinical research, 

epidemiological tools and scientific data — 

in coherence. 


new infections continue to occur in a 

constant or increasing trend, the population 

prevalence of antibodies is likely to decline 

with time after large spikes of infections. 

Such “antibody decay” is likely the cause for 

the declining prevalence of antibodies in the 

population, according to Dr Pinto. 

Others, however, beg to disagree. Some 

of them refuse to accept that a drop in 

antibody levels can be behind the survey 

results. Antibodies against the virus may 

drop to extremely low levels over a period 

of time, but it is highly improbable for them 

to vanish so quickly, they argue. 

“The falling levels of seroprevalence is 

a technical error and not due to waning 

immunity,” says Dr V Anil Kumar, Clinical 

Professor & Head, Microbiology, Amrita 

Institute of Medical Sciences, Kochi, Kerala. 

The microbiologist is convinced that the 

immune response to SARS-CoV-2 is similar 

to what was seen with its close cousin, 

SARS-CoV. In case of the SARS epidemic, 

antibodies remained in the system at 

detectable levels for at least 12 to 24 

months. 

Antibody levels in mild or asymptomatic 

cases can be low or even undetectable. 

Antibody titres are higher in critical patients 

when compared to non-critical patients 

due to different rates of maximal antibody 

response. Patients with severe disease 

become antibody positive earlier than those 

with mild disease. Longitudinal studies 

on 98 SARS-CoV patients have shown 

detectable levels of IgG for two years; 

however, the titres may have declined over 

this period. A similar study on 176 SARS CoV 

infected people found that antibody titres 

reduced by 33% within one year and 46% 

by two years. Antibodies to SARS CoV have 

been detected even 12 years after infection. 

On the discrepancy in the numbers 

of different surveys, Prof Anil Kumar 

said it is impossible to accurately gauge 

true prevalence by targeting selected 

populations in a country like India which is 

so heterogeneous with respect to culture, 

lifestyle, beliefs, socioeconomic status, 

the density of population and family size. 

Further, various state governments follow 

different approaches. 

Besides, seroprevalence is bound to be 

low when children and young. college-going 

As time passes, 

antibodies to SARS-CoV-2 

are known to decline 

rapidly. 

Dr Lancelot Pinto 

Consultant Respirologist 

P D Hinduja National Hospital 

and Medical Research Centre 

Mumbai. 

adults — the most active members of the 

society — are confined to their homes. The 

virus may have reached every nook and 

corner of the country, he adds, but it will 

still take long to hit every household. 

Epidemiologists say that the sampling 

methods adopted for these surveys 

could also influence their outcome. To 

ensure reliable results, surveys should 

make sure the cohort to be tested is 

representative of the larger population. 

This means the individuals to be surveyed 

are representative of the society at large 

by age, social and economic status, 

educational levels, areas of residence and 

other parameters. Likewise, the size of the 

sample should also be sufficiently large 

enough to proportionately represent all 

subgroups. Otherwise, such limitations 

will skew the intended distribution of the 

subjects. 

The harmonisation of sampling rules 


and analytical methods is another major step. It is highly 

unlikely that ICMR and the various states followed the same 

set of guidelines for their studies. A comparison of results 

becomes impractical if different surveys adopt different 

sampling methods, point out experts. Having such a common 

set of guidelines will also allow multiple surveys to pool their 

findings. 

They are calling upon organizations to publish their 

serosurvey protocols to bring about a fair understanding of 

the data and numbers being put out. 

The WHO has made available serological survey guidelines 

for numerous vaccine-preventable diseases like measles, 

rubella, etc. As far as COVID-19 is concerned, a protocol for 

serosurveillance was published by ICMR in Indian Journal of 

Medical Research in June 2020. The article had WHO regional 

office personnel as collaborators. So, a framework exists on 

which serosurveys can be modelled in India. 

Researchers, nevertheless, may face several challenges 

on this front. The selection of the population, points out Dr 

Anil Kumar, is a big challenge as the diversity of the Indian 

population is too high to achieve uniformity or a complete 

correspondence. This, for example, can be seen in the fact 

that serosurveillance of health care workers 

(HCW) in private hospitals may not show 

high prevalence when compared to those 

in government hospitals. Another reason 

is that, with each state’s epidemic curve 

behaving differently, it is very difficult to 

have consistent or uniform seroprevalence 

data for the country as a whole. 

Moreover, says Dr Anil Kumar, it is also 

too early to attempt to bring in uniformity 

in serological surveys as the assays are 

continuously being modified to overcome 

shortcomings. 

Implications of discordant results 

Seroprevalence studies the world over show 

that they are liable to have considerable 

variations in the results. Data from initial 

serosurveys conducted in the worst-hit 

Spain, for instance, found only a small 

fraction of the population of this European 

nation seropositive. 


Experience suggests that the 

underestimation of the true prevalence of 

the disease can have major implications 

for the epidemiological modelling of the 

infection as well as herd immunity. 

Epidemiologists say that several 

factors can influence the accuracy of 

seroprevalence study findings, particularly, 

the type of diagnostic kits used for 

testing and the sensitivity of the assays 

deployed in detecting the antibodies. 

Chemiluminescence-based ELISA has 

the best sensitivity but is prone to false 

positives in low prevalence settings. The 

target used in the antibody assay also will 

affect the sensitivity. 

Critics maintain that any kit with less 

than 99% specificity would be “pretty 

useless” in most seroprevalence studies. 

“Initial serosurveys [in India] were done 

using a rapid card test which was found to 

be unreliable due to high false negatives 

and false positives. Subsequent serosurveys 

were conducted using manual ELISA, which 

suffer from technical bias,” quips Dr Anil 

Kumar. 

The chemiluminescence based assays 

are very expensive and sensitive, but 

compromise on specificity to a small extent. 

The targets of the assays also vary, with 

each manufacturer making superior claims. 

The more commonly used nucleoproteinbased 

assays perform differently when 

compared to spike protein-based assays, he 

points out. 

The trimeric spike glycoprotein has a 

higher ability to detect antibodies to the 

virus than the nucleocapsid in people with 

a low level of antibodies. Anti-spike, but not 

nucleocapsid, IgG, IgA and IgM antibody 

responses were readily detectable in 

symptomatic and asymptomatic individuals, 

studies show. However, several diagnostic 

tests which are currently authorised for 

emergency use still consider only the 

nucleocapsid. 

Since the antibody response is directly 

proportional to the severity of the disease, 

the assays that target only nucleocapsids 

are likely to miss several mild and 

convalescent cases. Hence, the selection 

of the antigens that these tests target is 

critical. 

Seroprevalence studies carried out in 

Evidently, the tools that 

we have to assess the 

serological status of a 

population are far from 

perfect. 

Dr Sadia Khan 

Consultant Microbiologist 

Core Diagnostics, Gurgaon 

India provide a good template to show how 

surveys could go awry if the quality of the 

testing kits is not assured. 

In the first serosurveillance study done 

by ICMR in May-June 2020, two IgG ELISA 

kits by two different manufacturers were 

used to confirm seropositivity. 290 samples 

were positive by the first kit. On retesting 

with the second kit, only 157 of these were 

found positive. In this case, the study design 

addressed the possibility of eliminating false 

positives by labelling a sample seropositive 

only if it was positive by both kits, experts 

point out. 

“Evidently, the tools that we have to 

assess the serological status of a population 

are far from perfect,” comments Dr Sadia 

Khan, Consultant Microbiologist at Core 

Diagnostics, Gurgaon. 

Most antibody detection kits, be it rapid 

or ELISA/CLIA based kits, claim to have 

sensitivity and specificity of over 90%. 


Hence accuracy, which is derived from the 

sensitivity and specificity of these antibody 

detection kits, is claimed to be high, as per 

the manufacturer kit inserts. 

In a similar way, false negatives will skew 

our understanding of the spread of the 

disease, adds Dr Sadia. 

The authors of the ICMR study clarified 

in their report that the sequential use of 

COVID Kavach and Euroimmun ELISA helped 

them potentially reduce false positives 

to as low as 0.01% by obtaining a serial 

specificity of 99.99%. 

However, Dr Chandrakant Lahariya, a 

noted expert in epidemiology, public policy 

and health systems, has a slightly different 

FALSE NEGATIVES WILL SKEW 

OUR UNDERSTANDING OF THE 

SPREAD OF THE DISEASE. 

A DELAY IN TESTING CAN ALSO 

GIVE OUT FALSE NEGATIVES 

take on this. While sensitivity and specificity 

are important, he says, these are not 

everything. In any case, he adds, antibody 

kits reflect past infections. 

These factors limit the utility of 

standalone surveys. However, repeat surveys 

provide very useful guidance on trends. 

The timing of the survey is another 

crucial determinant. Recent studies show 

that SARS-CoV-2-specific IgG levels drop 

rapidly following recovery. Hence, a delay 

in testing can give out false negatives. 

Demographic factors, including age and sex, 

can also affect the calibration of the results. 

Guidance to public health policy; 

vaccine roll-out 

A serological survey uses blood samples to 

test for antibodies as markers of pathogen 

exposure to estimate the proportion of the 

population that has been infected. 

It is an important component of 

surveillance for infectious diseases. 

High-quality, representative serosurveys 

could provide an accurate assessment of 

immunity levels in the general population 

SEROPOSITIVITY 

HIGHER AMONG 

WOMEN 

Most of the surveys conducted in India seem to indicate 

that seropositivity appears to be higher in women than 

in men. The August sero-survey in Delhi found that the 

seropositivity rate (SPR) among females was higher at 24.2 

percent compared to 21.63 percent among males. 

It has also been found to be marginally higher in Mumbai 

as well. However the age-wise prevalence was found to be 

comparable in both males and females in Mumbai. Since the 

data has not been corrected for the lower sensitivity of 93 

percent of the CLIA kits, these figures represent a conservative 

lower estimate, notes the report. 

Levels of activation of immune cells are also higher among 

women than in men, studies suggest. Women generally 

produce higher levels of antibodies that remain in the 

circulation longer. The immune regulatory genes encoded by 

the X chromosome in female gender cause lower viral load 

levels and less inflammation than in men. 

The lower susceptibility to viral infections among women 

is attributed to a higher innate immunity, steroid hormones 

and certain factors related to sex chromosomes. Toll-like 

receptor 7 (TLR7) is higher among women than in men and 

its biallelic expression leads to higher immune responses and 

increases the resistance to viral infections. TLR7 is expressed in 

innate immune cells which recognize single-strand RNA virus 

by promoting the production of antibodies against the virus 

and the generation of pro-inflammatory cytokines, including 

IL-6 and IL-1 family members. 

THE GENDER BIAS 

Women in India seem to 

be better protected than 

men against SARS-CoV-2 

infection, reveal surveys 

21.63% 

SPR among males 

24.2% 

seropositivity rate (SPR) 

among females 


and are very useful to evaluate the 

susceptibility of a population to the 

disease. Using the susceptible, infectious 

and recovered (SIR model), they help 

to calculate the peak of a current or 

subsequent outbreak. No other tools are 

currently available to monitor an ongoing 

epidemic with the precision afforded by 

seroprevalence studies. 

Governments can use vital data 

generated by such surveys to frame 

effective public health policies during 

times of pandemics. Without them, the 

authorities would never be able to make 

crucial decisions such as how and when 

to reopen schools, cinemas etc, especially 

given that not all cases are being recorded 

in official registers. In other words, the more 

serosurveys they do, the better equipped 

they become. 

Health authorities can, by testing 

the same localities over time, follow the 

footprints of the virus moving through a 

community. A serological examination can 

also provide clues on ‘protective’ antibodies 

and their levels. 

These serosurveys are even more 

useful in case of SARS-CoV-2 as a good 

Besides providing useful 

data to make suitable 

interventions, serosurveys 

can also guide the 

optimal rollout of any 

vaccine. 

Dr V Anil Kumar 

Clinical Professor & Head 

Microbiology 

Amrita Institute of Medical 

Sciences Kochi, Kerala. 

proportion of people with COVID-19 show 

no outward symptoms. Despite the absence 

of symptoms, these studies can determine 

if a person has already been infected and 

recovered. 

Dr Sadia clarifies that the field 

experience with serological tests is often 

used for decision-making in communicable 

diseases. In a pandemic, this could translate 

to the lifting of movement restrictions or 

determination of containment zones. 

Most importantly, serosurveys can 

provide useful insights on herd immunity 

thresholds in different populations. 

Besides providing useful data to make 

suitable interventions, these surveys 

can also guide the optimal rollout of 

any vaccine, points out Dr Anil Kumar. 

Individuals with detectable antibodies 

need not be vaccinated in the first phase 

and a natural immunity of 60% or above 

should be good enough to block further 

transmission. Finally, pre-existing immunity 

will diminish the potency of any live 

attenuated SARS-CoV-2 vaccine. 

—With inputs from Prapti Shah 

from Mumbai 


drug approvals 

Orphan drug 

designation to 

sugemalimab 

to treat T-cell 

lymphoma 

CStone Pharmaceuticals 

announced that the US 

FDA has granted Orphan Drug 

Designation (ODD) to its anti- 

PD-L1 antibody sugemalimab 

(CS1001) for the treatment of 

T-cell lymphoma. 

T-cell lymphoma 

encompasses different 

subtypes, and extranodal 

natural killer cell/T-cell 

lymphoma (ENKTL) is a 

subtype with a particularly 

poor prognosis, the company 

said. 

In China, the current 

approved targeted 

monotherapy for these 

patients has a complete 

response (CR) rate of 

approximately 6%. An oral 

presentation of data from the 

CS1001-201 study, in which 

sugemalimab monotherapy 

was evaluated in patients with 

R/R ENKTL, was presented at 

the 2020 annual meeting of 

the Chinese Society of Clinical 

Oncology (CSCO). 

As of July 1st,2020, the 

objective response rate (ORR) 

of 38 evaluable patients was 

44.7%, with a CR rate of 

31.6%; the median duration 

of response (mDoR) was 16.8 

months and 1-year DoR rate 

is 67.8%. The median overall 

Pitolisant for treating 

cataplexy in US 

Pitolisant (Wakix) has been granted 

approval by the US FDA for the 

treatment of cataplexy in adult patients with 

narcolepsy. 

The drug is the first and only treatment 

approved by the FDA for people with 

excessive daytime sleepiness or cataplexy 

associated with narcolepsy that is not 

scheduled as a controlled substance by the 

US Drug Enforcement Administration, 

Pitolisant received FDA approval for the 

survival (mOS) of the 43 

patients who received 

study treatment was 19.7 

months, and the 1-year 

overall survival (OS) rate was 

55.5%. 

CS1001-201 is a singlearm, 

multicentre, phase II 

pivotal study designed to 

evaluate the efficacy and 

safety of sugemalimab 

as monotherapy for the 

treatment of R/R ENKTL. The 

primary endpoint of this study 

is ORR as assessed by the 

Independent Radiology Review 

Committee (IRRC). 

EMA panel 

recommends 

Trixeo 

aerosphere for 

COPD 

A 

straZeneca’s Trixeo 

Aerosphere (formoterol 

fumarate/glycopyrronium 

bromide/budesonide) has 

been recommended for 

marketing authorisation in 

the European Union (EU) for 

maintenance treatment in 

treatment of excessive daytime sleepiness 

in adult patients with narcolepsy in August 

2019, Harmony Biosciences said. 

Pitolisant is a selective histamine 3 

(H3) receptor antagonist/inverse agonist 

that works through a novel mechanism 

of action to increase the synthesis 

and release of histamine, a wakepromoting 

neurotransmitter in the brain. 

It is administered orally, once daily in the 

morning upon awakening. 

adult patients with moderate 

to severe chronic obstructive 

pulmonary disease (COPD) 

who are not adequately 


treated by a combination of 

an inhaled corticosteroid (ICS) 

and long-acting beta2-agonist 

(LABA), or a combination of 

a LABA and a long-acting 

muscarinic antagonist. 

The recommendation for 

approval was also supported 

by data from the KRONOS 

phase III trial. In both trials, the 

safety and tolerability of the 

aerosphere were consistent 

with the profiles of the dual 

comparators. 

The ETHOS and KRONOS 

phase III trials are part of 

AstraZeneca’s ATHENA phase 

III clinical trial programme 

for Trixeo Aerosphere, which 

included more than 15,500 

patients globally across 11 

trials. 

ETHOS is a randomised, 

double-blinded, multi-centre, 

parallel-group, 52-week 

phase III trial to assess the 

efficacy and safety of Trixeo 

Aerosphere in symptomatic 

patients with moderate to very 

severe COPD and a history of 

exacerbation(s) in the previous 

year. The primary endpoint 

was the rate of moderate or 

severe exacerbations. 

KRONOS is a randomised, 

double-blinded, parallel-group, 

24-week, chronic-dosing, 

multi-centre phase III trial 

to assess the efficacy and 

safety of Trixeo Aerosphere 

in patients with moderate to 

very severe COPD regardless 

of whether or not they had an 

exacerbation in the previous 

year. 

Antibody 

cocktail to treat 

Ebola 

Regeneron Pharmaceuticals 

Inc announced that the 

US FDA approved Inmazeb 

(atoltivimab, maftivimab and 

odesivimab-ebgn) for the 

treatment of infection caused 

by Zaire ebolavirus 

in adult and paediatric 

patients, including newborns 

of mothers who have 

tested positive for the 

infection. 

Inmazeb, previously called 

REGN-EB3, was created using 

Regeneron’s VelocImmune 

platform and associated 

VelociSuite technologies. The 

treatment consists of three 

monoclonal antibodies of 

similar structure, atoltivimab, 

maftivimab and odesivimab, 

that bind to different, nonoverlapping 

epitopes on 

Zaire ebolavirus glycoprotein. 

The three antibodies help 

neutralize the Ebola virus by 

blocking its ability to invade 

patients’ and/or enlisting 

other immune cells to target 

infected cells and remove 

them from the body 

The drug is administered 

as a single, weight-based 

intravenous infusion (50 mg 

atoltivimab, 50 mg maftivimab 

and 50 mg odesivimab 

per kg). 

EMA committee 

recommends 

cabotegravir 

for HIV-1 

V 

iiV Healthcare announced 

that the Committee for 

Medicinal Products for Human 

Use (CHMP) of the European 

Medicines Agency (EMA) has 

issued a positive opinion 

recommending marketing 

authorisation for cabotegravir 

injection and tablets (Vocabria) 

in combination with rilpivirine 

Inclisiran for high cholesterol 

treatment in EU 

The Committee for Medicinal Products 

for Human Use (CHMP) of the European 

Medicines Agency (EMA) has adopted 

a positive opinion and recommended 

granting marketing authorisation of 

inclisiran (Leqvio) for the treatment of 

adults with hypercholesterolemia or mixed 

dyslipidemia, Novartis said 

Inclisiran is a potential first-in-class 

small interfering RNA (siRNA) with 

a new mechanism of action which 

delivers effective and sustained lowdensity 

lipoprotein cholesterol (LDL-C) 

reduction for patients with atherosclerotic 

cardiovascular disease (ASCVD), ASCVD 

risk equivalent and heterozygous familial 

hypercholesterolemia (HeFH) a major 

driver of heart attacks, strokes and deaths. 

This CHMP opinion is based on 

results from the ORION clinical research 

programme including phase III 

trials, which involved more than 

3,600 patients on a maximally 

tolerated statin dose and assessed 

the safety, efficacy and tolerability of 

inclisiran. 

The drug demonstrated effective and 

sustained LDL-C reduction of up to 52% 

(P

Rare paediatric disease status 

to Tay-Sachs gene therapy 

Axovant Gene Therapies has received 

Rare Pediatric Disease Designation 

from the US FDA for AXO-AAV-GM2, a 

one-time gene therapy delivered directly 

to the central nervous system that is in 

development for GM2 gangliosidosis, also 

known as Tay-Sachs and Sandhoff disease. 

In addition to the Rare Pediatric 

Disease designation, AXO-AAV-GM2 has 

Orphan Drug Designation (ODD) and 

is the first gene therapy that has been 

administered to children with Tay-Sachs 

disease. 

The company plans to evaluate AXO- 

AAV-GM2 in a clinical trial which consists of 

a Stage 1 dose-ranging study and a Stage 

2 efficacy study. Previously, it reported 

the first evidence for potential disease 

modification in Tay-Sachs disease from 

an expanded access study administering 

investigational AXO-AAV-GM2 gene therapy 

in two patients with infantile (Type I) Tay- 

Sachs disease. 

GM2 gangliosidosis, also known as 

Tay-Sachs and Sandhoff disease, is a rare 

and fatal paediatric neurodegenerative 

lysosomal storage disorder (LSD) resulting 

from deficiencies in beta-hexosaminidase, 

a key enzyme in the lysosome. These 

genetic defects lead to the toxic 

accumulation of gangliosides, resulting in 

neurodegeneration and life expectancy 

shortened to just two to four years of age. 

AXO-AAV-GM2 is an investigational 

gene therapy for Tay-Sachs and Sandhoff 

disease, which rare and fatal pediatric 

neurodegenerative genetic disorders 

within the GM2 gangliosidosis family, 

caused by defects in the HEXA (leading 

to Tay-Sachs disease) or HEXB (leading 

to Sandhoff disease) genes that encode 

the two subunits of the ß-hexosaminidase 

A (HexA) enzyme. Both forms of GM2 

gangliosidosis are caused by overwhelming 

storage of GM2 ganglioside within 

neurons throughout the central nervous 

system), which is normally degraded in the 

lysosome by the isozyme HexA. 

AXO-AAV-GM2 aims to restore HexA 

levels by introducing a functional copy of 

the HEXA and HEXB genes via the delivery 

of two co-administered AAVrh8 vectors. 

injection and rilpivirine tablets, 

for the treatment of HIV-1 

infection in adults. 

If approved, cabotegravir 

injection used in combination 

with rilpivirine injection will be 

the first complete long-acting 

regimen, dosed once-monthly 

or once every 2-months, 

for virologically suppressed 

people living with HIV-1 across 

Europe. This treatment will 

offer people living with HIV 

an option with significantly 

less frequent dosing and 

comparable efficacy to daily 

oral regimens. Cabotegravir 

and rilpivirine injections 

are administered as two 

intramuscular (IM) injections 

in the buttocks during the 

same visit at a specialist clinic 

by a healthcare professional. 

Prior to the initiation of the 

injections, cabotegravir and 

rilpivirine oral tablets are 

taken for approximately one 

month (at least 28 days) 

to assess tolerability to the 

medicines. 

The Marketing 

Authorisation Application 

(MAA) for cabotegravir 

injection and tablets is 

based on the pivotal phase III 

ATLAS (Antiretroviral 

Therapy as Long-Acting 

Suppression), FLAIR (First 

Long-Acting Injectable 

Regimen) and ATLAS-2M 

studies. 

The ATLAS and FLAIR 

studies included more 

than 1,100 participants 

from 16 countries. The 

studies demonstrated that 

cabotegravir and rilpivirine 

when injected intramuscularly 

in the buttocks, oncemonthly, 

were as effective as 

continuing their daily, oral, 

antiretroviral regimens in 

maintaining viral suppression 

throughout the 48-week 

study period. The long-acting 

regimen was preferred by 

approximately 9 out of 10 

patients who switched to 

cabotegravir and rilpivirine 

long-acting in the ATLAS 

and FLAIR studies over their 

previous daily oral therapy. 


The Patient-Reported 

Outcomes data from the 

ATLAS-2M study showed 

high levels of treatment 

satisfaction and acceptance, 

with 98% (n=300/306) 

of participants who were 

randomised to receive an oral 

lead-in followed by once every 

2-months dosing preferring 

treatment once every 

2-months compared to daily 

oral treatment (oral lead-in). 

Results indicate 

that administration frequency 

and convenience were the 

most common reasons for 

preferring treatment every 

2-months. 

RHB-204 is 

orphan drug 

to treat NT 

mycobacteria 

disease 

RedHill Biopharma 


FDA has granted Orphan 

Drug Designation to RHB- 

204 for the treatment of 

nontuberculous mycobacteria 

(NTM) disease. 

A phase 3 study to 

evaluate the safety and 

efficacy of RHB-204 in 

patients with pulmonary 

NTM infections caused by 

Orphan drug status to 

sacituzumab for glioblastoma 

Immunomedics said the US FDA has 

granted sacituzumab govitecan-hziy 

(Trodelvy) orphan status for the treatment 

of adult and paediatric patients with 

glioblastoma. 

Sacituzumab is an antibody-drug 

conjugate (ADC) directed against Trop-2, 

a cell-surface protein expressed in many 

solid cancers. It binds to Trop-2 and 

delivers the anti-cancer drug, SN-38, to kill 

cancer cells. 

Immunomedics has multiple ongoing 

studies in triple-negative breast cancer, 

metastatic urothelial cancer, hormone 

receptor-positive/human epidermal growth 

factor receptor 2-negative metastatic 

breast cancer, and metastatic non-small 

cell lung cancer, either as a monotherapy 

or in combination with other agents. 

Mycobacterium avium Complex 

(MAC) is planned to be 

initiated soon in the US. 

The multi-centre, 

randomised, double-blind, 

placebo-controlled, parallelgroup 

phase 3 study is 

planned to be conducted at up 

to 40 sites across the US and 

aims to enroll 125 patients, 

randomised at a 3:2 ratio to 

receive either RHB-204 or 

placebo. 

Currently, there is no FDAapproved 

first-line standardof-care 

therapy for NTM. 

RHB-204 is a fixed-dose 

oral capsule containing a 

combination of clarithromycin, 

rifabutin, and clofazimine. 

Immunotherapy 

for treating MM 

gets Orphan 

drug status 

Glycostem Therapeutics has 

received the FDA’s Orphan 

Drug Designation (ODD) for 

the treatment of multiple 

myeloma (MM) patients with 

its investigational product 

oNKord. 

oNKord is a first-generation 

off-the-shelf natural killer 

(NK) cellular immunotherapy 

product. Over the coming 

months, AML patients will 

receive this form of treatment 

as part of a phase I-IIa 

(pivotal) trial in AML. A phase 

II trial for MM patients is 

expected to start in 2021. 

“Since 2012 we have 

been pioneers in the field of 

developing and manufacturing 

off-the-shelf natural killer cell 

therapy products for cancer 

treatment. In 2020 we’re 

entering a new and exciting 

phase,” says Troels Jordansen, 

CEO of Glycostem, in a 

statement. 

MM is the second most 

common blood cancer, 

accounting for 15% of blood 

cancers, and 2% of all cancers. 

MM occurs in infection-fighting 

plasma cells found in the bone 

marrow 

Orphan drug 

status to APG- 

115 & APG-1252 

to treat AML and 

SCLC 

Ascentage Pharma 


FDA has granted two Orphan 

Drug Designations (ODDs) 

to two of the company’s 

apoptosis-targeting assets: the 

MDM2-p53 inhibitor, APG-115, 

for the treatment of acute 

myeloid leukaemia (AML); 

and the Bcl-2/Bcl-xL inhibitor, 

APG-1252, for the treatment of 

small-cell lung cancer (SCLC). 

APG-115 is an orally 

administered, selective, small- 


Ivacaftor for treatment 

of CF in infants 

US FDA has given approval 

to ivacaftor for treatment of 

cystic fibrosis in infants aged four 

months to less than six months 

who have at least one mutation in 

their cystic fibrosis transmembrane 

conductance regulator (CFTR) gene. 

Ivacaftor is already approved 

by the FDA for treating cystic 

fibrosis in patients aged 6 months 

and older. 

This FDA approval is based on 

the results from a 24-week phase 3 

open-label safety cohort (ARRIVAL) 

trial consisting of 6 children with 

CF ages four months to less than 

six months who have one of 10 

mutations in the CFTR gene (G551D, 

G178R, S549N, S549R, G551S, 

G1244E, S1251N, S1255P, G1349D 

or R117H). 

This cohort demonstrated 

a safety profile similar to that 

observed in older children and 

adults. 

CF is caused by a defective 

protein that results from mutations 

in the CFTR gene. While there 

are approximately 2,000 known 

mutations of the CFTR gene, the 

most common is the F508del 

mutation. 

molecule inhibitor of MDM2. 

It has a strong binding affinity 

to MDM2 and is designed 

to activate the tumoursuppressing 

activity of p53 

by blocking the MDM2-p53 

protein-to-protein interaction 

(PPI). APG-115 is the first 

MDM2-p53 inhibitor entering 

clinical development in China, 

with multiple ongoing clinical 

studies in solid tumours and 

hematologic malignancies in 

China and the US. 

Prime 

designation to 

iptacopan in C3 

glomerulopathy 

Novartis said the European 

Medicines Agency (EMA) 

has granted Prime designation 

for iptacopan (LNP023) in C3 

glomerulopathy (C3G). 

C3G is an ultrarare 

and severe form of 

primary glomerulonephritis, 

characterised by complement 

dysregulation. It has a 

worldwide annual incidence 

of 1–2 per million and an 

approximate prevalence of 

10,000 in the US, ~10,500 in 

Europe, 3,200 in Japan and 

32,000 in China. 

Iptacopan is a first-inclass 

oral, small-molecule, 

reversible inhibitor of factor 

B, a key serine protease of 

the alternative pathway of the 

complement cascade. 

In addition to C3G, 

iptacopan is in parallel 

development for a number 

of other renal conditions 

with complement system 

involvement where significant 

unmet needs exist, including 

IgA nephropathy (IgAN), 

atypical hemolytic uremic 

syndrome and membranous 

nephropathy. 

Novartis is also 

investigating iptacopan 

in paroxysmal nocturnal 

hemoglobinuria (PNH). 

Following positive phase II 

data. A randomised, activecomparator 

controlled openlabel 

phase III trial to evaluate 

the efficacy and safety of 

iptacopan in PNH patients 

with residual anaemia despite 

treatment with anti-C5 

antibody therapy is planned to 

start in Dec 2020. 

Obiltoxaximab 

to treat 

inhalation 

anthrax 

Elusys Therapeutics Inc 

said that the Committee 

for Medicinal Products for 

Human Use (CHMP) of the 

European Medicines Agency 

has adopted a positive 

opinion recommending 

marketing authorisation under 

exceptional circumstances for 

obiltoxaximab, the company’s 

monoclonal antibody (mAb) 

anthrax antitoxin for the 

treatment of inhalation 

anthrax. 

The treatment is 

indicated in all age groups in 

combination with appropriate 

antibacterial drugs for the 

treatment of inhalational 

anthrax due to Bacillus 

anthracis; and for postexposure 

prophylaxis of 

inhalational anthrax when 

alternative therapies are not 

available or not appropriate. 

Obiltoxaximab is approved 

under the brand name Anthim 

in the US and Canada. 

Breakthrough 

therapy status 

to IMGN632 

for treating r/r 

BPDCN 

ImmunoGen said the US FDA 

has granted Breakthrough 


Therapy designation for 

IMGN632 for the treatment 

of patients with relapsed or 

refractory blastic plasmacytoid 

dendritic cell neoplasm 

(BPDCN). 

IMGN632 is a CD123- 

targeting ADC in clinical 

development for hematological 

malignancies, including 

BPDCN, acute myeloid 

leukaemia (AML), and acute 

lymphocytic leukaemia (ALL). 

The drug is currently being 

evaluated in multiple cohorts, 

including monotherapy for 

patients with BPDCN and 

minimal residual disease 

positive (MRD+) AML following 

frontline induction therapy 

and in combinations with 

azacitidine and venetoclax 

for patients with relapsed/ 

refractory AML. 

IMGN632 uses one of 

ImmunoGen’s novel indolinobenzodiazepine 

(IGN) 

payloads, which alkylate 

DNA without crosslinking. 

IGNs have been designed to 

have high potency against 

AML blasts while 

demonstrating less toxicity to 

normal marrow progenitors 

than other DNA-targeting 

payloads. 

BPDCN is a rare form of 

blood cancer that has features 

of both leukaemia and 

lymphoma, with characteristic 

skin lesions, lymph node 

involvement, and frequent 

spread to the bone marrow. 

ODD to CAR-T 

cells therapy for 

gastric cancers 

CARsgen Therapeutics 

Co Ltd said that the US 

FDA has granted orphan 

drug designation to one of 

CARsgen’s first-in-class drug 

candidates, CT041, for the 

treatment of gastric and 

gastroesophageal junction 

adenocarcinoma. 

CT041 is a humanised 

anti-claudin18.2 autologous 

chimeric antigen receptor 

(CAR) T-cell product and is 

targeted to treat patients with 

claudin18.2-positive tumours. 

CT041 is the first 

claudin18.2-targeted CAR 

T-cell therapy that has 

received Investigational New 

Drug (IND) clearance by 

the US FDA and the first to 

receive IND clearance by the 

National Medical Products 

Administration (NMPA) in 

China. 

The initiation of an openlabel, 

multicentre, phase 1b 

clinical trial (NCT04404595) 

to evaluate the safety and 

efficacy of autologous 

Dapagliflozin receives 

breakthrough therapy 

designation for CKD 

AstraZeneca’s 

dapagliflozin (Farxiga) 

has been granted 

Breakthrough Therapy 

Designation (BTD) in 

the US for patients with 

chronic kidney disease 

(CKD), with and without 

type-2 diabetes (T2D). 

The FDA granted 

BTD based on clinical 

evidence from the DAPA- 

CKD trial. The detailed 

results presented in 

August demonstrated 

that dapagliflozin on 

top of standard of care 

reduced the composite 

measure of worsening of 

renal function or risk of 

cardiovascular (CV) or renal 

death by 39% compared 

to placebo (absolute risk 

reduction [ARR] = 5.3%, 

p

arm study investigating the 

effects of burosumab on 

osteomalacia in adults with 

XLH. 

These two studies found 

that burosumab increased 

and maintained serum 

phosphate levels in the 

normal range, helped to heal 

pseudofractures and fractures 

related to osteomalacia, and 

improved osteomalacia. 

X-linked 

hypophosphataemia (XLH) 

is a rare, genetic disease 

that causes abnormalities 

in the bones, muscles, and 

joints. People with XLH 

have a genetic defect on 

the X-chromosome, which 

causes an excessive loss of 

phosphate through the urine 

and poor absorption from the 

gut, resulting in chronically 

low levels of phosphate in the 

blood. 

Golimumab to treat 

polyarticular juvenile 

idiopathic arthritis and PA 

Janssen said that the 

US FDA has approved 

golimumab (Simponi Aria) 

for patients 2 years of age 

and older for the treatment 

of active polyarticular 

juvenile idiopathic arthritis 

(pJIA) and has extended 

the active psoriatic arthritis 

(iPsA) indication for this 

same patient population. 

JIA is a group of 

disorders characterised 

by arthritis persisting for 

at least six weeks before 

the age of 16 years. 

The polyarticular form 

of JIA is most common 

and is characterized by 

inflammation in more than 

four joints and resembles 

adult rheumatoid arthritis 

(RA). 

The approval was 

based on results from the 

GO-VIVA phase 3 clinical 

trial, an open-label study 

in children with JIA with 

active polyarthritis ages 

2 to 17 years who had 

active arthritis in five 

or more joints, despite 

receiving treatment with 

methotrexate for at 

least two months. Trial 

results demonstrated that 

pharmacokinetic (PK) 

exposure of golimumab 

was consistent with that of 

two pivotal phase 3 clinical 

trials of golimumab in adult 

patients with moderately 

to severely active RA and 

active PsA. 

Efficacy was assessed 

as supportive endpoints 

through Week 52. The 

efficacy was generally 

consistent with responses 

in adult patients with RA. 

EMA accepts 

MAA for gene 

therapy to treat 

CALD 

The European Medicines 

Agency (EMA) accepted 

the marketing authorisation 

application (MAA) for 

investigational elivaldogene 

autotemcel (eli-cel, Lenti-D) 

gene therapy for the treatment 

of patients with cerebral 

adrenoleukodystrophy (CALD), 

bluebird bio announced. 

CALD is a fatal 

neurodegenerative disease 

primarily affecting young boys. 

Data from the phase 2/3 

Starbeam study (ALD-102) 

formed the basis of the MAA, 

which is also supported with 

data from the ongoing phase 

3 ALD-104 study and the 

long-term follow-up study 

(LTF-304). 

Eli-cel is a one-time 

investigational gene therapy 

designed to add functional 

copies of the ABCD1 gene into 

a patient’s own hematopoietic 

stem cells (HSCs) that have 

been transduced ex vivo with 

the Lenti-D lentiviral vector 

(LVV). 

The addition of a 

functional gene allows 

patients to produce the 

adrenoleukodystrophy protein 

(ALDP), which is thought to 

allow for the breakdown of 

very-long-chain fatty acids 

(VLCFAs) that accumulate to 

toxic levels in the brain. There 

is no need for donor HSCs 

from another person. 

The US FDA granted eli- 

cel Orphan Drug status, Rare 

Pediatric Disease designation, 

and Breakthrough Therapy 

designation for the treatment 

of CALD. 

Tofacitinib to 

treat active JIA 

Tofacitinib (Xeljanz) has 

been approved for the 

treatment of children and 

adolescents 2 years and older 

with active polyarticular course 

juvenile idiopathic arthritis 

(pcJIA), Pfizer announced. 

Two formulations were 

approved, a tablet and an oral 

solution, and are dosed based 

upon weight. This approval 

makes tofacitinib the first 

and only Janus kinase (JAK) 

inhibitor approved in the US 

for the treatment of pcJIA. 

This approval was based 

on data from a phase 3 

study including two phases: 

an 18-week open-label, 

run-in phase (including 225 

patients), followed by a 26- 

week double-blind, placebocontrolled, 

randomised, 

withdrawal phase (including 


Orphan drug status to elezanumab 

for treating spinal cord injury 

AbbVie announced that the 

US FDA has granted Orphan 

Drug and Fast Track designations 

for elezanumab (ABT-555), an 

investigational treatment for 

patients following spinal cord injury. 

Elezanumab is a monoclonal 

antibody of the human 

immunoglobulin (Ig) G1 

isotype that binds selectively 

to repulsive guidance 

molecule A (RGMa). RGMa is 

an inhibitor of axonal outgrowth 

and recognized as an important 

factor in inhibiting neuronal 

regeneration and functional 

recovery following central nervous 

system (CNS) damage. 

Elezanumab is being 

investigated to treat spinal cord 

injuries, multiple sclerosis and acute 

ischemic stroke. It is currently in a 

phase 2 study for the treatment of 

spinal cord injury. 

Currently AbbVie is partnering 

with the Shirley Ryan AbilityLab and 

MC10 in a pilot study involving 20 

spinal cord injury patients. 

The pilot study will inform 

the ongoing phase 2 study of 

elezanumab by testing optimal 

biosensor placement to capture 

surface electromyography (sEMG), 

among other assessments. 

173 patients) for a total 

duration of 44 weeks. 

The study evaluated 

the efficacy and safety of 

tofacitinib taken as either a 

5 mg tablet or as a 1 mg/mL 

oral solution twice daily based 

on the subject’s body weight 

(

straight talk 

“PATIENT PRIVACY AND 

DATA PROTECTION ARE OF 

PARAMOUNT IMPORTANCE” 

ResMed, a global leader in digital health 

with many cloud-connected devices 

such as ventilators and bilevel respiratory 

devices, recently stated that there could 

not be a clearer case for the use of digital 

health tools than in the ongoing COVID-19 

crisis. However, the company has always 

maintained that patient privacy is critically 

important while using these technologies. 

With reference to the recent IMA protest 

against the proposed National Digital Health 

Mission in India, SEEMA ARORA ResMed 

India’s National Marketing Head said that 

there should be strict data protection laws 

in place and only that will ensure that 

patient data is secured and protected when 

implementing digital health policies at 

the national level. Edited excerpts of 

Straight Talk with DIVYA CHOYIKUTTY 

ResMed is an established player in the respiratory care 

segment, and caregivers would naturally expect more 

innovative solutions from your company to fight the 

COVID-19 pandemic. Do you think you has been able to 

rise up to such expectations? 

ResMed has always been futuristic and proactive in 

adopting new technologies and solutions. Yes, there is 

a paradigm shift that has been observed globally in the 

immediate past, but we see multiple challenges in the 

adoption of these technologies in India, mainly due to low 

awareness. Our cloud care connective solutions for 

devices have been a step forward in this direction by 

enabling remote monitoring of patients and online 

consultations. In the recent past, the production of these 

cloud-care connected devices has gone up drastically, 

resulting in a surge in demand across the globe. 

Apart from products, we have used technology extensively 

to leverage our expertise and information for handling 

these crises by giving online advice and by giving ventilator 

training to our health care professionals through these 

virtual tools. 

Cloud-connected platforms are key enablers of 

digitisation in healthcare. But resource separation failure, 

privilege abuse and other privacy issues remain a big 

challenge. As a platform provider, how do you perceive 

and address these issues? 

Our strict protection policy ensures that patient data 

is always secured and protected with us. So, as soon as a 

patient buys a device, he has to sign a written consent for 

submitting data to ResMed. During therapy also, 

if he wishes not to send any data, he can do that by 

simply putting the machine on airplane mode. Data at our 

server location is always stored in an encrypted format 

and for that reason, all those who are working on this 

data never get to know the real identity of the patient. So, 

I think we have a strict data policy that’s being accepted 

worldwide. 

What are the different services that you provide apart 

from the cloud-connected respiratory devices? 


Seema Arora 

We have connected devices both 

for respiratory care as well as sleep 

care. Sleep care is basically [treating] 

obstructive sleep apnea and respiratory 

care is mainly handling COPD patients. 

Apart from this, we do a lot of initiatives 

for driving awareness among doctors as 

well as patients. A recent initiative, ‘wake 

up to good sleep’, is mainly to educate 

our doctors as well as our patients to 

understand the importance of the quality 

of sleep and the issues they are facing and 

manage those issues well. So, these are 

various initiatives that we are working on 

in India on the importance of sleep as well 

as respiratory medicine. 

In India, a doctors’ body has strongly 

opposed the National Digital Health 

Commission proposal released last 

One of the biggest 

concerns about 

digital healthcare 

in India is data 

security and patient 

privacy. 

Seema Arora 

Chief Marketing Officer 

ResMed 

year. Do you think that is going to have 

any impact on the prospects of digital 

healthcare in the country? 

One of the biggest concerns about 

digital healthcare in India is data security 

and patient privacy. I think, as far as health 

care is concerned, each and every piece 

of patient data has to be confidential 

and secure. New initiatives like NDHM 

give rise to a lot of logistical challenges 

and associated patient privacy issues if 

not implemented carefully. In this, the 

government will certainly collaborate 

with various hospitals—public as well as 

private, insurance companies, perhaps 

pharmacies and laboratories too. 

So, there is a greater chance of exposing 

the patient data at large to the risk of 

hacking or maybe commercial misuse 

even. 

Currently, NDHM is a voluntary exercise, 

like Aadhar was at the beginning. But it 

could become mandatory for availing of 

government health benefits, etc. So, I think 

patient privacy and data protection is of 

paramount importance. Before we make it 

a pan-India affair, I think the technical and 

implementation-based deficiencies need 

to be sorted out and the government 

needs to gain the confidence of all 

stakeholders, including civil rights bodies. 

There are also many questions that one 

has to answer, like who will manage and 

maintain the repository of such huge 

health data, and on whether the source 

or the individuals have rights to eradicate 

or erase some of the old health records, 

etc. I think those need to be addressed. 

But with strict data protection policy, we 

are positive [about this] and we believe 

that we can act as a catalyst to generate 

records for the government with individual 

consent. 

Though home care is picking up 

globally, India as a market hasn’t seen 

much momentum in this area. What is 

ResMed’s experience as a home care 

solutions maker? Why has the shift been 

slow in India? 

Globally, we have seen that a digitallyenabled 

healthcare pathway takes the 

centre stage when it comes to handling 

a crisis situation like COVID-19, which also 


accelerates the adoption of digital health technologies 

that ResMed is offering. It ensures out-of-hospital care 

for patients, optimising services and better patient 

outcomes. But we have a long way to go in this regard in 

India, mainly due to low awareness and less interest from 

doctors considering the cost as well as apprehensions from 

patients. We try to create awareness among doctors and 

patients through our communication initiatives about the 

positive aspects of homecare, like fewer readmissions and a 

better quality of life, etc. 

I also see only a handful of insurance companies 

providing reimbursement or support to home 

care or even for medical devices used by patients. 

I think more awareness needs to be created to 

improve patients’ acceptance, which can also increase 

affordability. 

Karexpert is a recently launched digital health care 

platform with built-in electronic health records, promising 

to take hospitals paperless in the future. Does ResMed 

have services similar to this? 

No, we don’t have such associations or the model 

available in India. We are basically focusing on the devices 

sector, involving respiratory devices and home care. 

How has been the market response to the home sleep 

test introduced by ResMed? 

There has been mixed review and acceptance of the 

home sleep test. But during the pandemic, people have 

started realising the importance of this, as it is accessible 

anywhere. ResMed’s home sleep test ApneaLink Air has 

been an effective tool for diagnosing obstructive sleep 

apnea in the comfort of your home. You need not have 

to visit any sleep lab or sleep clinic. With a potential sleep 

apnea population of four million, there are I think a handful 

of sleep labs here that will not be able to take the disease 

burden. So, the home sleep test has become critically 

important. 

We are also soon launching India’s first disposable 

home sleep test in the market called One Sleep Test. It is 

simple, safe and can accurately diagnose obstructive sleep 

apnea from the comfort of your home. It is a one-time use 

device. After you open the device you need to download 

the app and the device has to sync with that app. When 

you use the device, the information from the app goes 

to a cloud-connected software that can be accessed by 

a sleep specialist. The specialist can then go through the 

report and send the information and the test report to the 

patient’s email directly. 

What are the new areas that you are exploring in 

technology-led healthcare? 

We are optimising a lot of our cloud-connected 

devices technology. 

Many are yet to come in the market. I 

will not be able to comment much on it. 

Sleep apnea is something that may 

still not be familiar to many people, 

especially in India. People don’t think 

much about how they’re sleeping or why 

they might be snoring? But nowadays 

it’s getting highlighted via awareness 

programmes. So, what all technologies do 

ResMed as an expert in this area provide, 

to help people realise and tackle this 

condition? 

A lot of people who have potential 

symptoms of snoring and daytime 

sleepiness are not aware that 

this could be an indication of a medical 

condition called obstructive sleep 

apnea. The first and foremost thing 

is to make them understand. 

So, we have a lot of screening tools 

which are all digitally enabled and 

through which people can feed in 

their answers and make out whether 

they are suffering from such a medical 

condition. 

Once they understand the condition 

and want to go for a sleep test, then 

we have devices like the one sleep 

test. We also have a ResMed ApneaLink 

test that is also cloud-connected so 

they can diagnose their sleep and 

understand that this condition is actually 

obstructive sleep apnea. After that, we give 

them a trial of the devices that are again 

cloud-connected to our air-view platform 

where we manage your speech therapy 

and tell them how their quality is of sleep 

every day. 

Based on the interaction through 

our coaches, patients understand the 

importance of CPAP therapy in their life 

and then they can finally go and purchase 

the products. So, right from the screening 

to the diagnosis to the trial, we have sleep 

coaches who help them to understand this 

issue better and get them into therapy. 

From a respiratory care perspective, 

we have our bilevels that are available 

for home-care use and to some extent 

available for hospital use as well. Soon, 

we will be launching an updated platform 

for these connected devices in the bilevel 

segment. 


esearch snippets 

Nucleus accumbens 

linked to obesity 

in children 

Electronic blood 

vessels to replace 

diseased vasculature 

Shiyu Cheng et al developed 

electrically conductive artificial 

blood vessels that may serve as 

implants to replace diseased native 

vessels. The flexible and biodegradable 

constructs consist of a metal-polymer 

conductive membrane composed of 

poly (L-lactide-co-ε-caprolactone) 

that encapsulated three layers of its 

cell-based tissue-engineered blood 

vessel (TEBV). The researchers could 

stimulate the implanted blood vessels 

by passing an electric current through 

it which activated the endothelialization 

process and enabled controlled drug 

or gene delivery into specific parts 

of the vessel via electroporation. The 

endothelialization process encouraged 

the proliferation and migration of 

endothelial cells at the implanted 

site which allowed the integration 

of the implanted vessel within the 

surrounding tissue promoting healing. 

The researchers could deliver a green 

fluorescent protein (GFP) DNA plasmid 

in situ into three kinds of blood-vessel 

cells via electroporation. The functioning 

of the blood vessels has been tested 

in rabbits where they functioned as a 

successful replacement for the carotid 

artery. The implanted constructs allowed 

sufficient blood flow and did not produce 

an inflammatory response or narrowing 

over a period of three months. The 

findings pave the way towards new 

treatments via gene therapies, electrical 

Kristina M Rapuano et al revealed 

a significant association between 

differences in the microstructure of 

the nucleus accumbens (NAcc) region 

of the brain and obesity in children. 

Utilising restriction spectrum imaging 

(RSI)- a novel diffusion-weighted 

MRI technique, the team showed 

that microstructural differences in 

cell density of the subcortical NAcc 

region strongly correlated to weight 

gain in the same participants after 

1 year. The cohort included children 

aged 9 and 10 year involved in the 

ongoing Adolescent Brain Cognitive 

Development (ABCD) study. The 

findings suggested that high 

saturated fat diets increased gliosis 

and neuroinflammation in rewardrelated 

brain region NAcc, which 

in turn lead to further unhealthy 

eating and obesity. The findings 

were further confirmed in rodents. 

As an ongoing longitudinal study, 

ABCD would be further investigating 

causal relationships between brain 

microstructure and weight gain during 

childhood and adolescence. 

Source: PNAS October 12, 2020; https://doi. 

org/10.1073/pnas.2007918117 


stimulation, and electronically controlled 

drug release. 

Source: Matter October 01, 2020 DOI: https://doi. 

org/10.1016/j.matt.2020.08.029 

NfL in eyes 

may indicate 

neurodegeneration 

Manju L Subramanian et al identified 

neurofilament light chain (NfL) 

biomarkers in the vitreous humour of the 

eye which showed significant association 

with neurodegenerative disease-related 

biomarker proteins. For the study, the 

team aspirated undiluted vitreous fluid 

samples from 77 patients who were 

undergoing previously scheduled eye 

surgery. Sixty three percent of the 

subjects were male, and the average 

age was just over 56 years old. All 

the 77 samples contained NfL in their 

vitreous humour, and higher levels of 

the biomarker were parallelly associated 

with higher levels of Alzheimer’s diseaselinked 

proteins including amyloid-B and 

tau proteins. Notably, Nfl was found 

associated with Aβ40, Aβ42, and t-tau, 

and other select cytokines and vascular 

proteins. Additionally, NfL levels were not 

associated with apolipoprotein E (APOE) 

genotypes or systemic diseases such 

as diabetes. The study also confirmed 

that NfL levels were not influenced by 

the patients’ clinical eye conditions. The 

findings encourage future studies to 

evaluate the potential utility of NfL in the 

eye. 

Source: Alzheimer’s Research & Therapy 17 

September 2020 https://alzres.biomedcentral. 

com/articles/10.1186/s13195-020-00677-4#Sec1 

Cytokines IL-22 and 

IL-18 play crucial to 

prevent rotavirus 

infection 

Zhan Zhang et al demonstrated the 

mechanism by which cytokines IL-22 

Cellular motion resists 

metastatic colonisation 

Ángel Enríquez et al 

demonstrated the importance 

of the mechanical role of cells in 

the dormancy and reactivation 

of the disseminated breast 

cancer cells to metastasise. The 

researchers evidenced that the 

growth of breast cancer cells 

was suppressed due to the 

continuous motion of the 

lung cells. For the study, the 

researchers had developed a 

cell culture system that utilised 

magnets to exert a stretching 

force on a 3D fibronectin 

culture of breast cancer cells 

commonly found in early-stage 

lung metastases. The strain was 

applied across the 

cultured cells at 

the amplitude 

and rate 

and IL-18 acted to 

impede rotavirus (RV) 

infection. The team found 

that IL-18 and IL-22 prevented 

RV infection independently by 

distinct mechanisms that involved 

activation of their cognate receptors 

in intestinal epithelial cells (IEC). IL-22 

propelled IEC proliferation and migration 

toward tips of the intestinal villus 

which resulted in increased extrusion 

of highly differentiated IEC that served 

as the site of RV replication. The IL-18 

in contrast, induced cell death of the 

RV-infected IECs thus directly stopping 

the RV replication cycle and ejecting the 

that occurred in the lungs 

during normal respiration. The 

findings showed that healthy 

organs utilised motion to resist 

metastatic colonization. The 

mechanical stimulation increased 

(Yes-associated protein-1) YAP 

downregulation and matrix 

degradation rates in tumorigenic 

cells. The changes in the 

mechanical forces of the tumour 

microenvironment affected cell 

fate. The team expects the new 

microactuator system to yield 

more biological understanding of 

metastasis and serve as a platform 

for evaluating pharmacological 

inhibitors of the most lethal aspect 

of cancer progression. 

Source: Advanced Functional Materials 23 

September 2020 https://doi.org/10.1002/ 

adfm.202005021 

incompetent virus 

into the intestinal 

lumen. The mechanism 

decreased the number of RVinfected 

IECs resulting in rapid and 

complete expulsion of RV, even 

in hosts with severely 

compromised immune systems. 

The results suggested that 

these cytokines may support 

the clearance of other enteric 

viral infections. 

Source: Science Immunology 

02 Oct 2020: Vol. 5, Issue 

52, eabd2876 DOI:10.1126/ 

sciimmunol.abd2876 https:// 

immunology.sciencemag.org/ 

content/5/52/eabd2876 


Neuromodulation of tongue 

relieves tinnitus symptoms 

Brendan Conlon et al devised 

a noninvasive bimodal 

neuromodulation device treatment 

that delivered sound paired with 

electrical somatosensory stimulation 

to the tongue for tinnitus. The therapy 

drove extensive plasticity within the 

brain for tinnitus treatment in animal 

models. In the current study, the 

scientists tested the device among 

326 adults with chronic subjective 

tinnitus for a period of over 12 weeks. 

The device delivered sound to the 

ears and electrical stimulation to the 

tongue of the patients that stimulated 

the trigeminal nerve. The findings 

showed that the results persisted 

for12-months post-therapy with no 

treatment-related serious adverse 

events. The participants achieved a 

statistically significant reduction in 

tinnitus symptom severity at the end 

of therapy based on two commonly 

used outcome measures, Tinnitus 

Handicap Inventory (Cohen’s d effect 

size: −0.87 to −0.92 across arms; 

P < 0.001) and Tinnitus Functional 

Index (−0.77 to −0.87; P < 0.001). 

The findings supported the safety 

and potential utility of bimodal 

neuromodulation for tinnitus. 

Source: Science Translational Medicine 07 

Oct 2020: Vol. 12, Issue 564, eabb2830 DOI: 

10.1126/scitranslmed.abb2830 https://stm. 

sciencemag.org/content/12/564/eabb2830. 

abstract 

Researchers find 

target protein that 

may prevent COVID-19 

infection 

Jia Yu et al demonstrated that blocking 

a complement protein in the immune 

system pathway during the SARS- CoV- 

2 infection prevented immune reaction 

leading to organ damage. The team 

found that upon entry into the 

host the spike proteins on the 

surface of the SARS-CoV-2 virus 

bound to a large, complex sugar 

molecule heparan sulfate found on 

the cell surface and in the 

extracellular matrix. The 

initial binding prevented 

the complement control 

protein factor H from naturally 

binding to the molecule. This 

activated the alternative pathway 

of complement (APC) that 

caused inflammation and 

cell destruction. Facilitated 

by the binding, the virus 

used another cell-surface 

component protein known as 

angiotensin-converting enzyme 2 (ACE2), 

that helped the virus enter and infect 

the cells. The team also discovered that 

by blocking another complement protein, 

known as factor D, the APC wasn’t 

activated by the virus spike proteins and 

thereby stopping the destructive chain 

of events triggered by SARS-CoV-2. The 

findings call for an investigation into the 

drugs that can do the required blocking 

to prevent the infection. 

Source: Blood SEPTEMBER 2, 2020 https://doi. 

org/10.1182/blood.2020008248 

Ultrasound thermal 

shift assay rapidly 

diagnoses sickle cell 

disease 

Y 

onghui Ding et al fabricated a new 

rapid acousto thermal shift assay 

(ATSA) device to detect sickle cell 


disease. The device utilized ultrasound 

waves to heat haemoglobin protein 

samples and concentrate the precipitates 

for the rapid assessment of protein 

thermodynamic changes. Compared 

to conventional TSA methods, the 

ATSA technique enabled ultrafast, 

highly sensitive (7–34 fold higher), and 

label-free monitoring of protein-ligand 

interactions and protein stability. The 

procedures including sample handling, 

protein unfolding, and measurement, 

took place within a microfluidic chip 

in less than two minutes, unlike other 

current thermal shift assays. The ATSA 

could distinguish the sickle cell protein 

from normal protein in a relatively 

inexpensive way which can be used in 

low-resource settings. 

across the colon’s interior surface. The 

researchers observed the movement of 

the microbots in murine models using 

a high-frequency ultrasound imaging 

system. By turning the rotational axis 

of the magnet, the team achieved twodimensional 

directional control where 

the microrobot was steered along various 

trajectories, including a circular path and 

P-shaped path. The team loaded their 

microbots with a fluorescein payload 

which was delivered within the intended 

site. Furthermore, the constituent 

materials of the microbots- SU-8 and 

polydimethylsiloxane (PDMS), remained 

non-toxic to the murine fibroblasts. 

The microrobot system’s capabilities 

may be explored to help obtain tissue 

biopsies and in other in-vivo biomedical 

applications, suggested the investigators. 

Source: Micromachines 2020, 11(9), 861; https:// 

doi.org/10.3390/mi11090861 

Source: Small 06 September 2020 https://doi. 

org/10.1002/smll.202003506 

Microbot system 

enables targeted drug 

delivery to the colon 

Elizabeth E. Niedert et al devised 

microbots that could be delivered into 

the colon and controlled by an external 

magnetic field forming a precision 

drug delivery system. With an external 

rotating magnetic field, the microbots 

obtained energy to rotate and tumble 

Optogenetic therapy using 

opsin restores vision in mice 

Subrata Batabyal et al developed 

a new, highly photosensitive 

multi-characteristic opsin (MCO1) 

that could restore vision in blind 

mice when attached to retina 

bipolar cells using gene therapy. 

The researchers showed that 

the mice models regained 

retinal function and vision after 

treatment. The team found that 

ON-centre bipolar cells which 

remained downstream from the 

photoreceptors could take up the 

function of the latter in case of 

damage. So, when the MCO1 opsin 

gene was added to bipolar cells 

in a retina with nonfunctioning 

photoreceptors, light 

sensitivity was restored. 

The optogenetic therapy 

used adeno-associated virus (AAV- 

2) to deliver the MCO1 opsin into 

the eye. The researchers found 

no concerning safety issues in the 

immunohistochemistry of vMCO1 

transfected retinal tissues. The 

tissues showed bipolar specific 

expression of MCO1 in treated 

mice and were devoid of any 

inflammatory symptoms. Further 

ocular imaging using SD-OCT 

showed no change in the structural 

architecture of vMCO1-injected eyes. 

Using cells spared in degenerated 

retina the treatment may be able 

to help restore vision in humans, 

concluded the study. 

Source: Gene Therapy 22 October 2020 

https://www.nature.com/articles/s41434- 

020-00200-2 


column 

the cellview 

Reinfection and the endemic 

potential of COVID-19 

It is possible that some individuals may never develop 

long-lasting immunity against SARS-CoV-2 

DR RAJANI KANTH 

VANGALA 

The author is a medical 

scientist and former 

director of SGRF, 

Bangalore 

We have seen several reports of 

reinfections in which an individual 

has been subjected to SARS-CoV-2 

infection more than once. The persistence 

and ubiquity of common respiratory viruses 

like influenza, rhinovirus respiratory syncytial 

virus (RSV) etc are due to their ability to 

infect repeatedly. It is therefore important to 

consider the possibility that SARS-CoV-2 may 

turn endemic. 

In most cases, the human immune system 

develops a defense mechanism — including 

immunoglobulins, memory B lymphocytes and 

memory T cells — after an initial infection. This 

adaptive immune system must identify any 

reinfection and be able to prevent a re-entry 

by the virus. However, several viruses may 

evade the immune response, or may generate 

an insufficient response. Serological studies 

suggest that SARS-CoV-2 infections can 

induce antibodies. However, early results from 

experimental vaccination in primates suggest 

that these antibodies may not be sufficient 

for long-term protection or to activate the 

adaptive immune system. It is also known that 

SARS-CoV-2 infection is heterogeneous — with 

a range of reactions from the asymptomatic 

to the very severe. It is possible that some of 

these individuals may never develop immunity 

against the infection. 

There is also the waning immunity, in 

which the initial adaptive immune response is 

robust, but its potency disappears over time, 

leaving the host vulnerable to reinfection. The 

virus’ immune escape process can be due to 

serial passage through the host population, 

accumulating several point mutations. These 

mutations result in antigenic drift leading 

to conformational changes of viral surface 

proteins, disrupting the binding capabilities 

of previously generated antibodies and 

enabling reinfection. Other endemic human 

coronaviruses (HCoVs) like OC43, HKU1m 229E 

and NL63 indicate that reinfection is common 

within a year. In contrast, many pathogens 

which cause severe systemic effects elicit a 

long-lasting adaptive immune response, as 

seen in SARS survivors who have neutralising 

antibodies persisting for 2-5 years. Therefore, 

the severity of reinfection may influence the 

duration of protective immunity and long-term 

effects of SARS-CoV-2. To date, the responses 

among some patients reinfected by SARS- 

CoV-2 have been heterogeneous, including 

rare hospitalisations. Thus, serological and 

prospective studies are needed to determine 

the pathogenic severity and immune capability 

in reinfections. Should repeat infections 

become common, SARS-CoV-2 will likely 

become endemic outside vaccinated areas. 

The typical timelines when an individual 

experiences reinfection and seasonal 

differences in transmissibility will determine 

the pattern of endemicity. Other than in 

tropical areas, respiratory viral infections are 

common during cold weather. We know that 

in case of influenza, infections are the highest 

during the winter season when people are 

together and indoors for longer periods. On 

a large scale, co-occurring and overlapping 

infections of influenza and SARS-COV-2 

will pose a serious public health problem. 

However, if non-pharmaceutical interventions 

are adopted to mitigate SARS-CoV-2, it may 

reduce the magnitude of influenza infections. 

The seasonal occurrence and magnitude 

of infections of not just one pathogen but 

multi-pathogen system may need important 

studies of interaction dynamics at the 

clinical and molecular levels. The overlapping 

phases of infection between two or more 

pathogens may help in enhancing each other’s 

transmission and cross-neutralize, or have 

a devastating effect. All these possibilities 

need to be evaluated and large-scale studies 

are needed as environmental changes are 

imminent and we need to be prepared to face 

oncoming challenges. 


hospital news 

Aster DM wins awards for 

CSR efforts in Middle East 

Aster DM Healthcare has recently been 

honoured with two prestigious awards 

for its corporate social responsibility (CSR) 

and sustainability efforts as well as for its 

contributions towards tackling the COVID – 

19 pandemic in the Middle East and North 

Africa by The Dubai Chamber and the 

Arabia CSR Network. 

The group has been recognized for 

undertaking various sustainable initiatives 

aimed to provide energy-efficient worldclass 

healthcare, by the Arabia CSR 

Network. The group was presented with 

the Winner Award in the healthcare 

category at the 13th Arabia CSR Awards. 

Aster DM Healthcare’s social initiatives 

Medanta-Moolchand opens 

cardiac care centre in South Delhi 

Medanta has joined hands 

with Moolchand to launch 

Medanta-Moolchand Heart 

Centre, a super-specialty cardiac 

care institute at Moolchand 

Medicity, South Delhi. The 

Centre offers comprehensive 

cardiac care including emergency 

cardiac services. 

The Medanta Heart Institute in 

Gurugram houses sub-specialties of cardiac 

surgery, electrophysiology and pacing, 

clinical and preventive cardiology and 

through the CSR arm of the group has 

been conferred with the Dubai Chamber 

CSR Label for H1 Cycle 2020, the highest 

level of recognition for CSR efforts by 

businesses built on international standards 

while ensuring local relevance. 

The Arabia CSR Award is recognized 

by global and regional bodies such as the 

United Nations Global Compact, the United 

Nations Environment Programme and the 

League of Arab States. 

Aster Volunteers were able to touch 

more than 2 million lives through various 

initiatives in a short period, Dr Azad 

Moopen, Founder Chairman and Managing 

Director, Aster DM Healthcare said. 

interventional cardiology, led by 

an integrated team of medical 

experts. These super-specialists 

will now additionally provide 

specialized services to a larger 

number of patients in South 

Delhi. 

The Medanta-Moolchand 

Heart Centre will offer 24X7 

cardiac emergency services, clinical 

and preventive cardiology, non-invasive 

cardiology including preventive health 

check-ups and interventional cardiology. 

Apollo 

Hospitals starts 

Post-COVID-19 

Recovery 

Clinics 

Apollo Hospitals has 

launched the Post-COVID 

Recovery Clinics across its 

hospital network to address 

the rising number of patients 

who have recovered from 

COVID-19 but are suffering 

from the mid and long-term 

persistent effects of the 

infection. 

The Post-COVID Recovery 

Clinics will be manned 

by a team of specialists 

including neurologists and 

immunologists to help 

patients deal with the 

aftermath of COVID-19 and 

restore them to health. In 

Bengaluru, the Post-COVID 

Recovery Clinic will be 

conducted at the Apollo 

Hospitals, Bengaluru: 

Bannerghatta Road, 

Jayanagar & Seshadripuram. 

The clinics will initially 

be launched in Apollo 

hospitals treating COVID-19 in 

Chennai, Madurai, Hyderabad, 

Bengaluru, Mysore, Kolkata, 

Bhubaneswar, Guwahati, 

Delhi, Indore, Lucknow, 

Mumbai and Ahmedabad. 

It will be manned by a 

dedicated team consisting of 

a family physician assisted by 

a nurse. 

Over 50% of COVID-19 

patients suffer from problems 

that include breathlessness, 

chest pain and heart issues, 

joint pains, vision problems, 

and memory loss months 

after contracting COVID-19. 


special feature 

MOUNTING H 

FM makes a journey 

through the killing fields 

of COVID-19 at a time 

when the fatality of 

SARS-CoV-2 crosses the 

1 million mark 

COVID-19 fatalities crossed the 

one-million milestone on 28 

September as per the COVID-19 

case tracker maintained by Johns 

Hopkins University of the US — . 

“an agonizing milestone”, as 

described by UN Secretary-General 

António Guterres. 

What makes the figure “mindnumbing” 

is the fact that it was reached 

in just about 10 months from the time 

the new coronavirus was first detected 

in the city of Wuhan in China. It shows 

how powerful the devastation of the 

pandemic is, experts say. 

The infection may already have 

overtaken tuberculosis and hepatitis as 

the world’s deadliest infectious disease, 

and is still growing fast. 

With no parallel in more than a 

century, COVID-19 continues its rampage, 

infecting millions of people and afflicting 

entire economies. 

Many people believe that the actual 

figures on COVID-19 deaths could be 

far, far higher than reported, as different 

countries record infections and deaths in 

their own way. 

WHO’s top emergencies expert 

Mike Ryan says the reported numbers 

probably underestimate individuals 

who either contracted or died due to 

COVID-19. 

According to some unofficial 

estimates, about 6.4 percent of the 

people infected with the virus have now 

UNBRIDLED 

SPREAD; 

ALARMING TOLL 

The mortality numbers continue 

to rise as the deadly SARS-CoV-2 

contagion tightens its 

grip around the globe 

43,498,512 

people contracted the virus 

worldwide 

1,151,971 

died of COVID-19 

CASES VS DEATHS 

Country-wise case counts 

and mortality reported 

8,704,192 

7,946,429 

5,409,854 

1,520,800 

1,102,301 

1,209,651 

1,098,320 

1,025,052 

897,740 

895,326 

888,715 

716,759 

574,856 

542,789 

503,598 

455,398 

450,258 

400,251 

392,934 

371,630 

USA 

India 

Brazil 

Russia 

France 

Argentina 

Spain 

Colombia 

UK 

Mexico 

Peru 

South Africa 

Iran 

Italy 

Chile 

Iraq 

Germany 

Bangladesh 

Indonesia 

Philippines 

225,706 

119,502 

157,397 

26,092 

35,052 

29,301 

35,031 

30,348 

45,088 

89,171 

34,149 

19,008 

32,953 

37,479 

14,003 

10,671 

10,091 

5,818 

13,411 

7,039 


UMAN COST 

THE PANDEMIC 

PROBLEM 

Americas, Europe 

and parts of Asia are 

currently the worst-hit by 

the novel coronavirus 

US 

216,516 

UK 

45,365 

Spain 

35,031 

France 

35,018 

Italy 

37,479 

Iran 

32,953 

China 

4,735 

Brazil 

157,397 

India 

119,502 

DEATHS PER MILLION 

Case Fatality Rate of the 

SARS-CoV2 varies from country 

to country, region to region 

Peru 

Belgium 

Andorra 

Spain 

Brazil 

Bolivia 

Chile 

Ecuador 

USA 

Mexico 

India 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• • 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• • • • • • • • • • • • • • 

• • • 

1,034 

951 

931 

755 

742 

740 

732 

710 

701 

694 

87 

• ≈ 25 

DAILY AVERAGE DEATHS 

The number of people falling victim to 

COVID-19 has climbed from a few hundred in 

March to several thousand in late October 

445 

March 13 

6.4% 

of the people infected with 

the virus have now died 

worldwide. 

7130 

October 28 

Mar Apr May Jun Jul Aug Sep Oct 

*figures as on 28th October 2020 

Sources: FT and NYTimes 


died worldwide. 

Based on these trends, some 

models even suggest that the number 

of fatalities could exceed 3 million by 

January if the virus is allowed to spread 

unhindered. 

One of the noteworthy characteristics 

of COVID-19 mortalities is that most of 

these deaths occurred in developed 

countries and not in developing ones. 

Many of these deaths could have 

been avoided had people shown 

compliance with national mandates such 

as wearing face masks and maintaining 

social distancing, epidemiologists say. 

The US reported the highest number 

of deaths in the world, accounting for 

nearly 15 percent of the recorded global 

fatalities, followed by Brazil and India. 

Latin America is the current hot spot, 

accounting for more than one in three 

of all new deaths, fuelled by a surge in 

COVID-19 fatalities in Brazil, Mexico and 

several other countries in Central and 

South America. 

Europe’s coronavirus-related death 

rates overtook those in Asia in early 

US: MOST SEVERE 

The USA accounts for the 

highest number of cases and 

deaths from the SARS-CoV-2 

infection in the world 

US' share of 

global deaths 

due to COVID-19 

20% 

THE REPORTED COVID-19 

DEATHS DO NOT REFLECT 

THE TRUE SCALE OF 

CORONAVIRUS-RELATED 

MORTALITY AROUND THE 

WORLD, SAY EXPERTS 

March, with Italy, Spain and the UK 

becoming global hotspots. From mid- 

April, the focus shifted to the US, where 

the number of deaths has remained 

consistently high, although the focus 

of the epidemic has shifted from the 

northeast of the country to southern and 

western states. 

What is the true toll? 

Experts think the reported COVID-19 

deaths do not reflect the true scale of 

coronavirus-related mortality around the 

world. 

Inconsistencies in the number of 

coronavirus cases and deaths among 

nations are the result of various factors, 

including the ways countries test and 

report cases and record deaths. 

Some researchers say that these 

methodological problems can be fixed 

by measuring excess deaths. This 

measure utilizes the number of people 

who die from any cause in a given region 

and period, and then compare it with 

the recent historical average. 

Going by this measure, the number 

of excess deaths across Europe since 

March to September was found to be 

about 170,000, according to data from 

EuroMOMO, a network of epidemiologists 

who collect weekly reports on deaths 

from all causes in 24 European countries. 

The overall rate of excess deaths per 

100,000 people in America has been 

found lower than that of many western 

European countries despite large 

regional disparities. When COVID-19 hit 

cities on the east coast hard in March 

and April, most other states were able 

to stall major outbreaks through quick 

lockdown measures. 

Data about excess deaths are 

seldom available outside western Europe 

and the Americas. Most countries in 

Africa and Asia do not release such 

information. 

Fatality rates based on comparing 

deaths, though easy to calculate, can 

overestimate the true lethality of the 

virus, epidemiologists say. 

How many more 

Studies say that the number of deaths 

can go either way depending on the 

manner governments respond to the 

pandemic. 

The numbers could go up to 2.5 

million in total by next January if the 

current trends continue, estimates 

Institute for Health Metrics and 

Evaluation (IHME) at University of 

Washington. They might still fall 

dramatically if the countries go in for 

measures like universal mask-wearing. 

On the other hand, the toll can further 

worsen to 3.3 million by January 2021 

if governments remove precautions like 


social distancing and restrictions on 

social gatherings etc. 

Further, the number of deaths 

from non-COVID-19 causes, like the 

poor availability of treatment, nonvaccination, 

alcohol consumption and 

drug abuse during the pandemic can 

also inflate total death numbers. As such, 

determining death rates in the midst of 

a pandemic is not easy. 

Besides, the case fatality rate of this 

disease has been one of the biggest 

mysteries surrounding this pandemic 

due to the extreme variations seen 

from country to country. The death rate 

stands at about 13 percent in Italy, but it 

is one-tenth of this figure in neighboring 

Germany. In the US, it is around 4.3 

percent. Again, it varies widely among US 

states. The number is around 7 percent 

in Michigan while it is about 0.7 percent 

in Wyoming. In South Korea, 2 percent of 

people who tested positive for the virus 

have died. The death rate in Wuhan in 

China is estimated to be 1.4%, whereas 

in India it is close to 1.5% according to 

official figures. 

Epidemiologists, however, maintain 

that anything above 1% means very 

many deaths. The fatality rate for the flu 

virus is 0.1%. A small percentage of a big 

number is still a very big number, they 

point out. 

The US already has the highest 

number of cases in the world and the 

most recorded deaths of any country. 

Though its 330 million people only 

represent roughly 4.25 percent of the 

world’s population, the country accounts 

for just over 20 percent of the deaths 

from COVID-19. 

As the daily coronavirus death tolls 

continue to go up in many places in the 

world with the onset of colder weather 

in the northern hemisphere and the 

reopening of more and more workplaces 

and schools, the counts are set to 

increase. 

Eventually, most viruses lose their 

virulence due to lack of hosts, mutations 

that make them less deadly, or new 

treatments or vaccines. The novel 

coronavirus will too, experts say, but it is 

a question of when and at what cost. 

BEHIND INDIA’S LOW 

COVID-19 MORTALITY 

India has reported nearly 8 million 

cases of COVID-19 in the fourth week 

of October 2020, with 118,000 officially 

confirmed deaths. 

According to the health ministry, 

the national recovery rate has been 

continuously increased to 90% and 

the case fatality rate is down to 1.51%. 

Indian Council of Medical Research 

(ICMR) guidelines stipulate that deaths 

of people with suspected or probable 

COVID-19 should be included in 

mortality data, based on WHO ICD-10 

codes for COVID-19-related deaths. The 

guidelines, however, are only advisory 

and not mandatory. Consolidated data 

is not available in the public domain. 

In India, healthcare is the responsibility 

of the states and it is up to individual 

states to follow the reporting guidelines. 

Only 22% of all deaths happening 

in India are medically certified under 

the civil registration system as most 

of the deaths occurring in rural India 

are outside hospitals. More than 

70% of India’s population lives in the 

hinterlands. 

However, public-funded serological 

surveys suggest at least 10 times the 

official number of people may have 

already been infected. This could mean 

that many deaths could have gone 

unreported. 

Despite concerns around underreporting, 

studies point to several 

factors that work in tandem to lower the 

COVID-19 mortality numbers in India. 

First, the bulk of the Indian population 

is young, with a median age of 28.4, 

according to the UN World Population 

Report. Public health experts say that 

older people, who are more likely to 

have comorbidities such as diabetes or 

hypertension, are more likely to die from 

COVID-19. 

The Indian government slapped 

lockdown restrictions at a time the 

pandemic was already raging in Italy 

and other regions of Europe. This time 

lag might have helped Indian doctors 

learn from the experience of other 

countries to manage the pandemic in a 

better way. 

Another theory going round is that 

other endemic viral diseases such as 

dengue fever might have given the 

population some antibody protection 

against the coronavirus. 

Greater toll accuracy is possible 

if there is more testing and better 

recording of deaths, and post-mortem 

examinations are carried out on 

suspected victims. Experts say that even 

though health is a state responsibility, 

the centre can enforce standards. 

Monitoring the number of deaths 

above “normal” levels and deaths at 

home could help, experts said. 

Mumbai, the country’s worst-hit city, 

found 13,000 excess deaths in March- 

July compared with the same period last 

year, reports said. 

Deaths may also have increased as 

the pandemic has made it harder for 

doctors to treat other conditions other 

than COVID-19. 

1.5% 

people with COVID-19 

die in India, according to 

official estimates 


devices&gadgets 

Olympus launches PCF-H190T 

and PCF-HQ190 colonoscopes 

Olympus announced the 510(k) 

clearance and market availability of two 

colonoscopes, the PCF-H190T and the PCF- 

HQ190. 

The new colonoscopes which expand 

capability in minimally invasive procedures, 

including endoscopic submucosal dissection 

(ESD). 

PCF-H190TL/I endoscope is a slim, 

short-bending scope that allows for tighter 

angulation without compromise to the 

passage of treatment accessories. Used with 

the EVIS EXERA III imaging platform, the 

PCF-H190TL/I is an HD device with a 510(k) 

claim for Narrow Band Imaging (NBI), which 

Bracco 

introduces 

infusion system 

for cardiac PET 

imaging 

Bracco Diagnostics Inc 

has received the US 

FDA approval for its new 

CardioGen-82 infusion system 

to enhance automation, 

efficiency and simplicity in 

cardiac position emission 

tomography (PET) myocardial 

perfusion imaging (MPI). 

The new infusion system 

is designed with intuitive and 

ergonomic details that provide 

easy access to all system 

components while minimizing 

radiation exposure for staff 

and patients. 

Other smart features 

enable workflow efficiencies 

that can save nearly an hour at 

indicates NBI as a “high confidence” assist 

to an experienced endoscopist employing a 

validated polyp classification system such as 

the NBI International Colorectal Endoscopic 

(NICE) classification, aiding in distinguishing 

diminutive adenomatous polyps from nonadenomatous 

polyps during a colonoscopy. 

Other features include a better 

retroflexion capability, a technique 

associated with improved adenoma 

detection rate (ADR), appropriate 

channel layout for passage of therapeutic 

accessories, such as for hemostasis or 

polypectomy and improved insertability to 

minimise patient discomfort. 

the beginning of each day of 

patient imaging and eliminate 

manual record keeping. A 

choice of dosing options and 

other protocol parameters 

make changes in scheduling 

and patient needs easy to 

accommodate. 

Cardiogen-82 (Rubidium 

Rb 82 Generator) is a closed 

system used to produce 

rubidium Rb 82 chloride 

injection for intravenous 

administration. Rubidium 

Rb 82 chloride injection is a 

radioactive diagnostic agent 

indicated for PET imaging 

of the myocardium under 

rest or pharmacologic stress 

conditions to evaluate regional 

myocardial perfusion in adult 

patients with suspected 

or existing coronary artery 

disease. 

Tyber’s foot and 

ankle plating 

systems get 

510(k) clearance 

T 

yber Medical LLC received 

a US FDA 510(k) clearance 

for its new line of foot and 

ankle plating systems. 

The FDA clearance covers 

over 42 different indicationspecific 

anatomical plating 

families. 

The company will 

launch its first phase of 

foot and ankle plates in 

the first half of 2021. 

The plating systems 

are indicated to treat a 

comprehensive range of 

deformity, trauma, and 

degenerative conditions 

to the forefoot, midfoot, 


earfoot, and ankle. 

The systems feature a 

30-degree, multi-angle, locking 

mechanism optimized for 

superior stability between 

the plate and screws. An 

intuitive, modular, tray delivery 

system is customizable with 

a colour-coded, clean layout 

that is consistent with the 

surgical flow to meet surgeons’ 

instrumentation needs. 

The systems include low 

profile (1.3mm) plates to 

minimise soft tissue irritation 

while maximising the variable 

locking technology to reduce 

screw head prominence. 

Additionally, the sterile 

and non-sterile plates include 

an engineered combination 

of material and surface 

modification which significantly 

increases fatigue resistance. 

Medtronic 

partners with 

The Foundry to 

develop mitral 

valve tech 

Medtronic announced a 

partnership with The 

Foundry, a medical device 

company incubator, to develop 

an innovative transcatheter 

mitral repair technology 

(TMVr). 

The partnership combines 

Medtronic’s leadership 

in Structural Heart and 

intellectual property with 

The Foundry’s track record 

of innovation in the field of 

transcatheter mitral valve 

repair and replacement. 

The arrangement provides 

for structured investment 

tranches from both Medtronic 

and The Foundry and 

includes an exclusive right 

for Medtronic to acquire 

the resulting company, Half 

Moon Medical, contingent 

upon the achievement of 

certain technical and clinical 

milestones. 

Half Moon recently 

received US FDA approval 

of an early feasibility 

study in patients with 

severe, symptomatic mitral 

regurgitation and expects first 

implants soon. 

EU approves 

ex vivo organ 

perfusion system 

CytoSorbents Corporation 

and Aferetica srl 

announced the EU approval 

of Aferetica’s PerLife ex vivo 

organ perfusion system and 

CytoSorbents’ ECOS-300CY 

sorbent cartridge for the 

removal of inflammatory 

mediators during ex vivo organ 

perfusion. 

The integrated system 

was developed in concert to 

improve the preservation and 

quality of solid organs, like the 

kidneys and liver, following 

harvest and prior to transplant 

into a new recipient. 

PerLife is an integrated, 

therapeutic system for organ 

transplant to provide both 

perfusion and purification 

of the kidney and the liver, 

following organ retrieval and 

before organ implantation. 

The platform consists of an 

all-in-one machine capable 

of covering the broad range 

of temperature preservation 

techniques (hypo-, normo-, 

and sub-normothermic) 

while incorporating the 

CytoSorbents ECOS-300CY 

perfusion cartridge to remove 

inflammatory mediators that 

can compromise the health 

and quality of the organs. 

The main goal of 

combined therapies is to 

increase successful solid 

organ transplants by helping 

to preserve good organs, 

rehabilitate sub-optimally 

functioning ones, and to 

increase the overall pool of 

viable organs to meet the 

growing worldwide demand 

for transplanted organs, the 

companies said. 

Magnolia introduces 

specimen diversion device 

Magnolia Medical Technologies Inc has 

launched its new Steripath Micro Initial 

Specimen Diversion Device. 

Micro is the first US FDA 510(k)-cleared 

device indicated to reduce blood culture 

contamination, the company said. 

The device is lightweight, lower diversion 

volume, easy-to-use with syringe-driven 

diversion and collection. It leverages the 

trusted ISDD technology while diverting less 

than 1.0 mL of blood, engineered for patients 

with low-blood volume and difficult venous 

access. 

The Steripath Microarchitecture uses 

syringe-driven negative pressure to divert 

and sequester the initial 0.6 to 0.9 mL 

of blood. Once diversion is complete the 

user simply presses a button to isolate the 

diverted blood and automatically a second 

independent blood flow pathway opens to 

collect the blood specimen for culture into 

the syringe 

US FDA grants 

510(k) clearance 

to digital surgery 

platform 

I 

mmersiveTouch Inc 

announced that the US FDA 

has provided 510(k) clearance 

for its ImmersiveView Surgical 

Plan (IVSP) digital surgery 

platform. 

IVSP saves surgeons 

time by providing an intuitive 

software suite to plan cases 

independently with help from 

biomedical engineers, cutting 

surgical planning time by as 

much as 75%. IVSP is the only 

service that provides patientspecific 

3D models with 

every case to enhance clinical 

performance, according to the 

company. 

IVSP allows surgeons 

to visualize and plan for 

surgery using immersive 

medical imaging and surgical 

simulation. It gives the 


surgeon, via an Oculus headset 

and hand controllers, the 

ability to study patient-specific 

anatomy, tumour margins, vital 

structures and deformative 

analysis. 

Boston Scientific 

launches spinal 

cord stimulator 

in EU 

Boston Scientific announced 

the European launch of the 

WaveWriter Alpha portfolio of 

Spinal Cord Stimulator (SCS) 

Systems. 

The portfolio, consisting 

of four MRI conditional, 

Bluetooth-enabled implantable 

pulse generators (IPGs), offers 

expanded personalisation 

based on patient needs, 

including rechargeable and 

non-rechargeable options, and 

access to waveforms that can 

cover multiple areas of pain. 

SCS therapies provide pain 

relief by delivering pulses of 

mild electric current to the 

spinal cord to interrupt pain 

signals traveling to the brain. 

The WaveWriter Alpha 

SCS Systems received CE Mark 

and are indicated as an aid in 

the management of chronic 

intractable pain. It is also 

indicated for peripheral nerve 

stimulation of the trunk for 

pain management. 

The systems feature 

combination therapy, the only 

SCS portfolio that has the 

ability to layer paraesthesia 

and paraesthesia-free options 

simultaneously, and support 

up to 32 contacts that target 

specific nerves along the spinal 

cord to meet the personal 

pain relief coverage needs 

of the individual patient. The 

Bluetooth platform enables 

faster programming that can 

be done while maintaining a 

typical physical distance of 10 

feet (3meters) between the 

programmer and the patient. 

ACURATE neo2 

aortic valve 

system launched 

in Europe 

Boston Scientific Corporation 

has started a controlled 

launch of the ACURATE 

neo2 Aortic Valve System in 

BD receives US FDA 

510(k) for FACSLyric 

flow cytometer 

Becton, Dickinson and 

Company has received 

510(k) clearance from 

the US FDA for the BD 

FACSLyric Flow Cytometer 

with the Integrated 

BD FACSDuet Sample 

Preparation System. 

The new integrated 

system enables clinical 

laboratories to fully 

automate the sample 

to answer process and 

improve their efficiency 

by reducing errors and 

limiting the manual user 

interactions required to run 

assays on the BD FACSLyric 

Flow Cytometer. 

The BD FACSDuet 

Sample Preparation System 

builds new capabilities into 

the BD portfolio of clinical 

flow cytometry solutions 

offering a pre-analytical 

system, that combined 

with the BD FACSLyric 

Flow Cytometer is the first 

truly walkaway sample-toanswer 

solution for clinical 

labs. 

Physical integration 

between the BD FACSDuet 

Sample Preparation System 

and the BD FACSLyric 

Flow Cytometer allows 

technicians to load samples 

and reagents onto the 

BD FACSDuet Sample 

Preparation System and 

obtain results once the 

samples are acquired 

and analyzed on the BD 

FACSLyric Flow Cytometer. 

Europe. This next generation 

transcatheter aortic valve 

implantation (TAVI) technology 

is a new platform designed 

with a number of features 

to improve upon the clinical 

performance of the original 

ACURATE neo platform. 

The ACURATE neo2 valve 

system also has an expanded 

indication for patients with 

aortic stenosis who are 

considered appropriate 

candidates for the therapy by 

their heart team, including a 

cardiac surgeon. 

Indicated to restore 

function and normal blood 

flow through a severely 

narrowed aortic valve, the 

ACURATE neo2 Valve System 

features a new annular 

sealing technology designed 

to conform to irregular, 

calcified anatomies and 

further minimize paravalvular 

regurgitation or leaking (PVL). 

In addition, the delivery 

system simplifies access 

to smaller and complex 

vessels at the entry site and 

allows for highly accurate 

valve positioning while 

the top-down deployment 

mechanism further supports 

stable placement and release 

to ensure the best patient 

outcomes. 

Data from the ACURATE 

neo2 CE-Mark Study 

demonstrated PVL rates for 

the ACURATE neo2 Valve 

System to be lower than 

previously reported with the 

current generation ACURATE 

neo valve. At 30 days and 

1 year after implantation, 

respectively, 97% and 97.5% 

of patients experienced = no/ 

trace or mild PVL, 3.0% and 


Photocure receives EU patent 

for cervical device 

Photocure ASA has said the 

European Patent Office (EPO) 

has granted patent EP 2983780 

covering the commercial 

Cevira device in Europe 

until 2034. 

Cevira is a photodynamic 

drug-device combination 

product under development for 

non-surgical treatment of highgrade 

cervical dysplasia. 

In July 2019, Photocure 

announced that it had entered 

into a License Agreement 

providing Asieris Meditech Co., 

Ltd with a world-wide license 

to develop and commercialise 

Cevira for the treatment of HPVinduced 

cervical precancerous 

lesions. In July 2020, Asieris 

received China NMPA’s approval 

to start a global phase III clinical 

trial for APL-1702 (Cevira). 

The EP 2983780 patent 

covering the commercial Cevira 

device in Europe will expire 09 

April 2034. 

Cevira is easily placed on 

the cervix by the gynecologist 

and removed by the patient, 

with no disruption of normal 

daily activities. Only one or two 

treatments are needed. 

High-grade cervical 

squamous intraepithelial lesions 

(HSIL) are a precancerous 

condition caused by a persistent 

HPV infection, a highly prevalent 

sexually transmitted disease 

resulting in approximately 10 

million cases with high-grade 

disease and > 500 000 new 

cases of cervical cancer each 

year. 

2.5% of patients experienced 

moderate PVL and 0% of 

patients experienced severe 

PVL. 

Abbott 

introduces 

next-gen ICD 

and CRT-D 

devices in India 

Abbott has introduced new 

implantable cardioverterdefibrillator 

(ICD) and cardiac 

resynchronization therapy 

defibrillator (CRT-D) devices. 

The devices offer 

remote monitoring through 

smartphone connectivity 

and connected applications. 

Additional benefits include 

improved battery longevity and 

MRI compatibility. 

CRT-Ds are used to prevent 

sudden death similar to 

traditional ICDs, but in addition 

act to restore the heart’s 

natural pattern of beating in 

patients with reduced cardiac 

function and progressive heart 

failure despite optimal medical 

therapy. 

The new system pairs 

with Abbott’s secure remote 

monitoring app which is 

smartphone compatible. 

Through the app, physicians 

can monitor their patients 

remotely, allowing for the 

identification of asymptomatic 

episodes as well as patienttriggered 

transmissions, which 

can lead to earlier intervention. 

In addition to enhanced 

remote monitoring capabilities, 

this CRT-D system includes 

multiple point pacing and 

optimisation features to help 

more patients respond to CRT 

therapy. 

Philips 

launches 

system for blood 

clot removal 

R 

oyal Philips announced 

the launch of the 

innovative QuickClear 

mechanical thrombectomy 

system. 

The compact, single-use 

system provides an all-in-one 

aspiration pump and catheter 

for the removal of blood 

clots from the vessels of the 

peripheral arterial and venous 

systems. 

The system’s innovative 

all-in-one design is simple to 

use while eliminating the need 

for capital equipment or costly 

accessories, with easy setup 

supporting faster procedures 

times. 

QuickClear simplifies 

the entire thrombectomy 

procedure workflow. 


GYNECOLOGY 

PAEDIATRICS 

WOMEN COULD CONCEIVE 

AFTER OVARIAN TUMOURS 

Women receiving fertilitysparing 

surgery (FSS) for 

treatment of borderline 

ovarian tumours (BOT) were able 

to have children, find a study from 

Karolinska Institute in Sweden published 

in Fertility & Sterility. 

In FSS, gynecologic oncologists 

remove the cancerous ovary and 

connected the fallopian tube, which 

carries the egg to the uterus. 

The study showed that natural 

fertility was preserved in most of the 

women and only a small proportion 

required assisted reproductive 

treatment such as in vitro fertilization. 

Survival in the group was also as high 

as in women who had undergone 

radical surgery for the treatment of 

similar tumours. 

The study examined the effects of 

FSS on fertility in women of a fertile age 

treated for early-stage BOT. FSS which 

preserves the uterus and at least 

parts of the ovaries is the most 

common option for women wishing 

to preserve fertility. 

The relapse risk after FSS is larger 

than after radical cancer treatment, in 

which the uterus and both ovaries are 

removed, but the advantages make it 

an accepted course of action for young 

women. 

Of the 213 women who underwent 

FSS between 2008 and 2015 in 

Sweden, 23 percent had given birth to 

62 babies after treatment. A minority — 

20 women or 9 percent of the cohort 

— had undergone IVF. 

New portable 

ultrasound probe 

improves imaging 

The digital health company 

Butterfly Network, has released 

a new generation handheld, 

single-probe, portable wholebody 

ultrasound device named as 

Butterfly iQ+. The device features 

better imaging capabilities, 

improved ergonomics, and 

longer battery life compared to 

its previous model Butterfly iQ. It 

has Needle Viz technology that 

aids with imaging a needle during 

in-plane guided procedures. The 

entire ultrasound is the size of 

a conventional transducer and 

it relies on a smartphone for 

the controls and to display the 

images generated. The company’s 

“Ultrasound-on-Chip” technology 

reduces noise while using only 

a small amount of electricity. To 

improve the image, the Butterfly 

iQ+ uses digital micro-beam 

forming right on the chip to 

improve frame rates by 15% and 

achieve a 60% higher frequency. 

50 

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FOR MEDICAL 


CASE REPORT MEDICAL PRACTICE PULMONOLOGY GENETICS 


Epidural analgesia may up risk 

of autism in offspring: Study 

The use of epidural 

analgesia for vaginal 

delivery in mothers may 

increase their risk of longterm 

neurodevelopmental 

disorders in the children, 

find researchers at the 

Kaiser Permanente 

Baldwin Park Medical 

Center, Baldwin Park, 

California. 

The study revealed 

an association between 

maternal u epidural 

analgesia (LEA) exposure 

and risk of autism 

spectrum disorders (ASDs) 

in offspring using data 

from 147, 895 singleton 

children born through 

vaginal delivery between 

January 1, 2008, and 

December 31, 2015. The 

data was derived based 

on electronic medical 

records from a single 

integrated health care 

system. 

Among the cohort, 

74.2% were exposed to 

maternal LEA and the 

relative risk of developing 

ASD was found 37% 

higher in this group. 

Sepranolone in trials for 

menstrual migraine 

Asarina Pharma AB is set to 

kickstart its phase 2a study of 

sepranolone, as the first therapy to 

focus exclusively on the treatment 

of menstrual migraine (MM). As 

many as 158 women have been 

recruited across seven test centres 

in Sweden and Finland. 

Sepranolone is a powerful 

neurological compound, produced 

naturally in the body, that 

modulates the effects of the 

neurosteroid allopregnanolone 

(ALLO). ALLO is a potent 

neurosteroid implicated in 

stress- and compulsionrelated 

conditions ranging 

from Tourette to OCD, 

PTSD, compulsive gambling, 

addiction, PMDD. 

PGI resumes 

OPD services 

The Post 

Graduate 

Institute of Medical 

Education and 

Research (PGIMER), 

Chandigarh, is 

set to resume 

physical OPDs in 

a limited format 

from November 

2. Departments of 

General Surgery, 

Internal Medicine, 

Paediatric 

Medicine, 

Obstetrics and 

Gynaecology, and 

Ophthalmology 

will conduct daily 

OPDs, it said. 

A fixed number 

of 50 patients will 

be seen in each 

OPD to maintain 

social distancing. 

However, the 

number of 

patients visiting 

OPDs will be 

suitably increased/ 

decreased as the 

COVID-19 situation 

unfolds, it added. 

Hypothyroidism in 

mothers linked to 

ADHD in children 

Low levels of key thyroid 

hormone in mothers 

during the first three months 

of pregnancy may interfere 

with the baby’s brain 

development, find a large 

American study. 

Children whose mothers 

were diagnosed with 

hypothyroidism shortly 

before or during the early 

stages of pregnancy were 

24 percent more likely to 

have ADHD than children 

whose mothers did not have 

the diagnosis. 

Among the study, 

findings were that once a 

pregnancy had reached the 

second trimester, a woman’s 

hypothyroidism had little 

effect on her children. 

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MAY 2019 

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AS AN ADD-ON THERAPY, BIOLOGICS HAVE OPENED UP 

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esearch 

COVID-19 INFECTION 

DYNAMICS AND 

FLATTENING OF CURVE 

Policymakers are relying on data generated from epidemiological models 

which are still evolving 

DR RAJANI KANTH VANGALA 

Information about the spread of 

COVID-19, such as the rate of 

infection, death rates and so on are 

important to all stakeholders, including 

the public and the policymakers. There 

have been several statistical approaches 

which have been used to model the 

spread, and data has been used to 

predict when the peak infection will be 

and when the curve will start flattening 

and so on. 

Several graphs depicting the 

expected number of infections have 

been viral in the media and social 

networks right from the beginning of the 

pandemic. Such mathematical models 

have projected many ominous trends. 

These graphs, however, never received 

much attention, but now they are 

informing important decisions such as 

financial planning, healthcare allocations, 

public policy and even speculations. 

The government, policymakers and 

regulatory authorities have used such 

models to evaluate and plan mammoth 

changes in operations and economies 

affecting the 1.3 billion people in India, 

even before researchers have concrete 

models and understand the dynamics. 

Experimental tools 

There is more than one way of 

modelling any epidemic, including pure 

mathematical abstractions or statistical 

SEIR MODEL 

The compartmental approach 

used here is one of the most 

common way of modelling 

pandemics 

REMOVED 

(Dead) 

SUSCEPTIBLE 

EXPOSED 

INFECTED 

RECOVERED 

models and those based on artificial 

intelligence and network theories. The 

current modellers are mixing several 

elements as they fumble in the darkness 

of this pandemic using different tools, 

creating new ones or adapting existing 

ones as more information becomes 

available. One of the most common 

approaches is called the compartmental 

model, in which a population is 

categorized into several groups with 

specific rules governing how these 

groups behave. 

The first category or group is 

susceptible or S, the second is exposed 

(E), the third is infected (I) and the 

last one is recovered or removed (R). 

In this model, the E group or category 

was added later and the initial models 

were SIR models. When people got reinfected, 

it became a SIRS model. The 

addition of the ‘exposed’ group made it 

a SEIR or SEIRS model. This basic model 

usually has numbers and equations for 

each category and their transitions to 

the next. The graph generated for the 

R (removed) population will usually be 

a sigmoid or elongated S-curve as the 

number of dead or recovered increases 

initially and then plateaus or reduces 

gradually. Forecasting based on this 

approach depends heavily on several 

factors like biology, politics, the economy 

and the weather. 

Institute for Health Metrics and 

Evaluation (IHME) used a different 

approach called the curve-fitting model 


which assumed that the situation in the 

U.S would resemble earlier infection 

curves and it did predict the trends till 

about 50,000 cases. In mid-April, the 

IHME model predicted that the death 

toll would reach 60,000 in mid-May. 

However, the actual number was around 

80,000. Later they moved to a SEIR 

model and are now evolving a better 

predictive system. An independent data 

scientist from MIT developed the YYG 

system, where only daily deaths were 

used with a set of parameters such 

as the reproduction number and the 

infection mortality rate in a grid search. 

The SEIR model soon took centerstage 

as machine learning approaches were 

incorporated along with deep-learning 

and neural networks. In comparison 

to these data-driven methods, agentbased 

models developed by the 

University of Sydney had a three-layer 

system using demographics, mobility 

and disease characteristics. 

Network approach 

Several countries have clearly passed 

the first wave of the epidemic and are 

potentially heading for the next one. 

The linear growth pattern of infection 

continues for several weeks and the 

implementation of non-pharmaceutical 

interventions (NPIs) such as social 

distancing and masks have certainly 

helped in keeping the infection rates 

down. 

Going by basic epidemiological 

concepts, the growth patterns with 

extended linear regions should be rare, 

with mathematically linear growth for 

an extended period usually indicating 

the failure to implement solutions in the 

compartments or categories mentioned 

in the SEIR method. Therefore, there 

is a need to use newer methods such 

as network interactions to explain the 

long-term linear growth of infections. 

For example, the use of the social 

network graph theory gave a reasonable 

explanation. A concept called smallworld 

network — which tries to capture 

the social links (degree), groups (or 

families), how long a person can be 

contagious and potential overlaps along 

THE FIRST 

WAVE 

A fraction of the 

source patients 

disproportionately 

transmit the infection 

to a larger number of 

target patients 

10% 

of 

with distant groups with leisure links 

— can give a better understanding and 

calibrated framework. 

With a population of more than 1.3 

billion and the second-highest number 

of registered COVID-19 cases so far, 

India needs to understand and develop 

containment strategies at national, state 

NEARLY TWO-THIRD OF THE 

PATIENTS HAVE NO IDENTIFIED 

SOURCE OF INFECTION AND 

A SMALL GROUP HAS MORE 

THAN ONE SOURCE 

and local levels. It was clear that around 

10% were the first wave of patients who 

were infected outside India and the 

rest were cases of local transmission. 

A recent article by Karikalan Nagarajan 

(BMC Medical Research Methodology 

20, 233 (2020)) has used a network 

approach leveraging large-scale 

contact tracing data around COVID-19. 

The availability of such relational 

patients 

infected out of 

India and the rest 

were infected 

due to local 

transmission 

data consisting of linked patients and 

contacts enabled such network analytics 

to be performed. In their cohort, the 

majority (88.72%) of the patients did 

not transmit the infection. However, a 

small number of 0.65% of the source 

patients disproportionately transmitted 

the infection to 36.7% of target patients. 

As for the remainder, around 62% 

did not have any identified source of 

infection and 1.72% had more than 

one source of infection. The data also 

showed that there were differences 

among individual patients in terms 

of infecting others and transmitting 

through an intermediary to many others. 

The network hubs suggested that there 

are only a few actors in the network 

playing a very important role in being 

the source and intermediaries for the 

infection transmission (often called 

super-spreaders). This kind of network 

analysis gives precise data on individualpatient-level 

variations in transmission. 

The network model-based prediction 

methods could help in identifying key 

super-spreader patients and develop 

important public health planning 

systems to achieve a reduction in the 

spread of COVID-19 infection. 


esearch 

APPROACHES TO DEVELOPING 

LONG-ACTING COVID VACCINES 

T-cell driven vaccine strategy may hold the key to long-term 

protection against SARS-CoV-2 

The COVID-19 pandemic has 

infected over 31 million individuals 

and claimed over 1.1 million lives 

globally as of late October 2020. SARS- 

CoV-2, the virus causing COVID-19, 

belongs to the coronavirus family and 

shares 79% genome sequence identity 

with SARS-CoV. The spike antigen used 

by the virus to enter host cells became 

the prime target for immediate vaccine 

development efforts because of prior 

work on SARS-CoV, which showed 

that neutralizing antibodies against 

the spike antigen protected mice and 

chimps against new infection. Currently, 

over 166 vaccines are in development 

against SARS-CoV-2. These can be 

divided into two major categories – 

THE SPIKE ANTIGEN 

BECAME THE PRIME 

TARGET FOR VACCINE 

DEVELOPMENT EFFORTS 

BECAUSE OF PRIOR WORK 

ON SARS-COV 

those using nucleic acid (DNA/RNA), 

and those using proteins (antibodies, 

viral proteins, inactivated/attenuated 

viruses and virus-like particles). Five 

vaccine candidates based on different 

approaches – RNA-based delivery of 

spike protein (Moderna), RNA-based 

delivery of receptor-binding domain 

(RBD) of spike protein (Pfizer/BioNTech), 

DNA-based delivery of spike protein 

(Inovio), non-replicating adenovirusbased 

delivery of spike protein (Oxford/ 

AstraZeneca and CanSino Biologics) 

and inactivated virus (Sinovac) are in 

or have completed phase-I/II trials. 


Preliminary data from some of these 

trials show the induction of neutralizing 

antibodies against the spike antigen. 

T-cell immunity is relatively less robust in 

treated individuals. At present, efficacy 

data are lacking to conclude whether 

the induction of neutralizing antibodies 

alone will be sufficient to protect 

individuals from new infections. 

Several features of SARS-CoV-2 

infection are unique and do not follow 

the path of other respiratory viruses. 

For example, infected individuals remain 

asymptomatic despite carrying a high 

viral load, thereby becoming a potent 

source of viral transmission. Further, the 

immune response against SARS-CoV-2 

is skewed towards a TH1/TH2 CD4 

T-cell response, which results in severe 

immune toxicity in 15-20% of infected 

individuals. Based on studies in other 

respiratory viruses, the development 

of protective immunity against SARS- 

CoV-2 in vaccinated individuals may 

face certain challenges. First, the 

mucosal antibody response is shortlived 

against respiratory viruses and 

shows a similar trend in SARS-CoV-2, 

raising concerns about whether an 

FIGURE 1 

B AND T-CELLS IN ADAPTIVE IMMUNITY 

100,000 

Antibody response 

10,000 

1000 

100 

10 

1 

0 

Primary 

infection 

Time to 

disease 

IgM 

IgG 

Secondary 

challenge 

Limited or 

no disease 

Shows that B cells (left) and T cells (right) elicit a very similar activation profile postinfection. 

Both cell types get activated and generate IgM/IgG or effector cells aiding in 

antigen clearance and then maintain low levels of IgG or memory cells for long term 

immunity. 

Image sources: Introductory Immunology, 2nd Edition, Modified from CD8 T Cell Exhaustion 

During Chronic Viral Infection and Cancer, Annual Reviews of Immunology 2019. 

antibody response alone is sufficient 

for long-term protection. Second, some 

vaccinated individuals can experience 

life-threatening immune toxicity when 

exposed to the virus. Our understanding 

of how the immune system interacts 

with the vaccine and how this interaction 

Antigen load 

MPEC 

7 14 21 0 6 14 0 7 14 60 

Duration (Days) 

Duration (Days) 

Naive 

Teff 

Trm 

Tmem 

will translate to a response during 

active infection remains rudimentary 

and therefore a source of concern, 

especially in older individuals who are 

both susceptible to infection and also to 

immune toxicity, but need the vaccine 

most urgently. A good vaccine will 

FIGURE 2 

T-CELL 

ACTIVATING 

EPITOPES 

OncoPept platform developed at MedGenome is an integrated Immuno-informatics 

platform that aids the identification of personalized CD8 immunomodulatory 

epitopes. Post sequencing peptides are analyzed by the patented OPVAC2 

(OncoPeptVAC2.2) algorithm that prioritizes CD8 T-cell-activating epitopes. These 

epitopes are further validated for a robust CD8 T-cell functional response and the 

quality of the T-cell response is assessed by T cell receptor sequencing. 

OncoPept 

platform 

1 2 3 4 5 

Antigen 

identification 

Predicting 

immunogenic 

antigen 

Validating 

antigen for 

T cell activation 

Quality of T cell 

response 

Validated 

antigens 

OncoPeptSEQ 

OncoPeptVAC 

OncoPeptSCRN 

OncoPeptTCR 

Vaccine Candidates 

Sequencing at high 

depth 

Validated bioinformatics 

pipelines 

HLA epitope pair 

identification 

Fewer false positives 

Dendritic cell - T cell 

assay 

PBMC assay 

Single HLAAPC assay 

Bulk TCR seq 

Single cell TCR seq + GEX 

Viral TCR indentification 

pipeline 

Epitope engagers 

(viz. TCR-T) 


engage both T-cell and B-cell immunity 

to provide immediate pathogen 

clearance and induce memory for longterm 

protection. 

Historically, the B-cell memory 

arm responsible for pathogen-specific 

neutralizing antibodies is characterized 

in greater detail in vaccine development 

studies. Figure 1 (left) demonstrates how 

B-cells secreting IgM molecules provide 

short-term clearance of pathogens 

and pathogen-infected cells, while 

concurrently maturing into IgG secreting 

plasma cells that confer long-term 

protection. The kinetics of the T-cell arm 

Figure 1 (right) follows a similar profile 

where antigen-experienced T-cells 

expand in number, differentiates into 

a killer phenotype, and clears infected 

cells. Following clearance of the infection, 

T-cells persist as resident memory cells 

in the tissues and as effector memory 

cells in circulation, becoming sentinels 

to prevent future infections. While the 

B-cell arm of adaptive immunity has 

been widely emphasized in vaccine 

development, T-cell mediated immunity 

has remained underexplored primarily 

due to lack of right technologies. 

However, significant technological 

advancements in the last decade have 

galvanized the study of T-cell mediated 

immunity in human diseases. 

The activation of T-cells is MHCpeptide 

dependent. T-cell receptors 

(TCR) on CD8+ cytotoxic T-cells and 

CD4+ helper T-cells bind 9-15-mer 

peptide fragments in complex with 

MHC (referred to as HLA for humans). 

These peptides are recognized as 

foreign (non-self) and activate T-cells 

to generate protective immunity. A 

large diversity of MHC genes and their 

polymorphic variants bind millions of 

peptide fragments from proteins and 

non-protein antigens and present them 

to a large diversity of T-cells expressing 

~ 106 - 109 unique TCRs. A single 

peptide can mobilize and activate many 

T-cells each expressing a unique TCR. 

Identifying a good TCR-MHC-peptide 

pair that can clear pathogens is the holy 

grail of cellular immunology. Figure 2 is 

a schematic of MedGenome’s OncoPept 

FIGURE 3 

ANTIGENIC REGIONS OF SARS-COV2 

Globally dominant common cold coronavirus strains (1, 2, 3, 4) are listed in the grey box. 

The bottom panel shows conserved antigenic regions of SARS-COV2 with common cold 

viruses that may confer some degree of immune resistance in humans. 

platform that identifies potent MHCpeptide-TCR 

combinations for efficient 

pathogen clearance and protective 

immunity. 

T-CELLS and COVID-19 

In early April, the OncoPept team 

conducted their very first immune 

assays with peptide pools from the 

A PART OF THE GLOBAL 

POPULATION MAY BE 

PROTECTED AGAINST THE 

CURRENT PANDEMIC AS A 

RESULT OF PRE-EXISTING 

IMMUNITY 

spike antigen of SARS-CoV 2 and 

were surprised to observe pre-existing 

T-cell immunity in healthy donors 

who were unexposed to the virus. 

Sequence alignment analysis revealed 

the possibility that a part of the global 

population may be protected against 

the current pandemic as a result of 

pre-existing immunity against other 

‘common cold viruses’’ in the coronavirus 

family. In fact, a recent study in Cell 

reports that many healthy individuals 

have both CD4+ and CD8+-T cells that 

elicit an antigenic response to the new 

coronavirus even though they have never 

been exposed to SARS-CoV or MERS. 

Going back to clues on de novo CD8 

immunity against SARS-CoV-2, earlier 

infection by SARS-CoV can perhaps shed 

some key insights since it is one of the 

closest homologs in the phylogenetic 

tree. Patients who had recovered from 

SARS-CoV back in 2003 had indeed 

presented an antibody response 

that faded within two or three years. 

Interestingly these patients also elicited 

detectable virus-specific robust T cell 

response 10-17 years after the infection 

had disappeared. These startling pieces 

of evidence support the notion that 

perhaps targeting T-cell driven immunity 

may be a key to a robust long-term 

immune protection against the COVID-19 

pandemic in the population. 

The OncoPept platform was used 


to assess CD8 T-cell-targeted immunity 

to the spike protein, demonstrated to 

be highly immunogenic in SARS-CoV 

studies. The algorithm identified CD8 

T-cell epitopes restricted to 23 HLAs. 

Figure 4 shows certain HLAs were 

restricted to a small number of peptides, 

whereas other HLAs presented many 

peptides. If an HLA presents a few 

peptides from a pathogenic organism, 

the immune system may not register 

its presence and will fail to mount a 

protective response. Our prediction 

analysis indicated that individuals 

harboring HLA-A:03 or A:23 will present 

fewer peptides for immune recognition 

and individuals carrying these HLAs 

may be more susceptible to infection. 

Interestingly, a study showed that 

individuals carrying HLA-A*03 and A*23 

were indeed more susceptible to SARS- 

CoV than individuals carrying HLA-C*15 

and HLA-A*33, which bound many more 

peptides (Figure 4). The data is purely 

correlational but supports the idea 

that CD8 T-cell immunity is critical for 

developing a robust protective SARS- 

CoV-2-specific immune response. 

Possible challenges in design 

Published studies from phase-I/II vaccine 

THE USE OF A 

FULL-LENGTH ANTIGEN 

MAY RESULT IN 

IMMUNO-DOMINANT 

T-CELL RESPONSES 

OUTCOMPETING 

SUB-DOMINANT ONES 

clinical trials by different groups have 

indicated a milder CD8 T-cell response 

against the spike antigen. It is possible 

that potent T-cell responses may lie 

in regions outside the spike protein as 

shown by the presence of memory T-cell 

responses against nucleocapsid protein 

and the non-structural proteins NSP7 

and NSP13 gene products from the 

ORF-1 region in convalescent individuals. 

Identification and characterization of 

these epitopes and their inclusion in 

a selected vaccine cocktail may yield 

a more robust and targeted T-cell 

protective effect. 

Another important consideration 

while using full-length spike 

antigen over “selected epitopes” 

with immunogenic potential is the 

phenomenon of epitope dominance. 

The use of a full-length antigen 

may result in immuno-dominant 

T-cell responses outcompeting subdominant 

ones. In many scenarios, 

these immuno-dominant epitopes 

saturate MHC molecules on cells and 

mobilize large families of TCRs with 

reduced cytotoxic potential. This is a 

common mechanism employed by 

viruses as a means of evading the 

immune system. The response can be 

FIGURE 4 

SUSCEPTIBLE ALLELES IN SARS-COV INFECTIONS 

Bar plot depicting HLA-wise prediction of immunogenic SARS-CoV2 CD8 epitopes 

by OPVAC2. HLAs predicted to present fewer epitopes (red arrows) appear to 

be reported as susceptible alleles in the highly homologous SARS-CoV infections 

highlighting the importance of CD8 T cell immunity. 


FIGURE 5 

T-CELL ANTIGEN DISCOVERY: TIMELINES 

Chronology of technological advances that have facilitated and revolutionized 

immunoinformatic methods of CD8 T-cell antigen discovery. Massive parallel genome 

sequencing allowed a truly personalized approach to CD8 epitope identification. Advanced 

mass-spectrometric methods have allowed direct identification of CD8 epitopes presented 

on the cell surface. T-cell receptor sequencing and its functional characterization by singlecell 

transcriptomics allow assessment of CD8 response at a single TCR clone level. 

2012 

2013 

in the past decade shown in Figure 

5 have exponentially increased our 

understanding of antigen recognition 

at a molecular level that allows the 

development of rationally designed 

vaccines. The concept of a selective 

vaccine cocktail constituting B-cell and 

T-cell epitopes that induce a pathogentargeted 

immune response is becoming 

a reality. This, in combination with the 

rapid growth of immuno-informatics 

methods leveraging machine learning 

and artificial intelligence (ML/AI) wherein 

bioinformatics techniques alongside 

the substantial amount of experimental 

evidence, is collated to inform rational 

vaccine design. 

Massively parallel genome sequencing allows 

personalised epitope identification 

2014 

TCR sequencing allow T cell donality 

assessment induced by antigens 

made broader and potent by utilizing a 

rational selection of sub-dominant T-cell 

epitopes or immuno-dominant epitopes 

that mobilize a productive and robust 

cytotoxic response for a well-rounded 

T-cell immunity. 

An important hallmark of SARS- 

CoV-2 infection is viral pneumonia 

accompanied by pulmonary 

inflammation and edema characterized 

by eosinophilic infiltrates. A current 

study highlights the critical role of 

host TH17 inflammatory responses in 

mediating this process. Elevated TH17 

High sensitive mass spectrometric methods 

for detection of T cell activating epotopes 

2017 

High throughput single cell sequencing to 

identify functional state of T-cells 

responses were also observed previously 

in MERS-CoV and SARS-CoV patients. 

Also, studies in experimental animals 

using vectored vaccines have reported 

substantial immune enhancement in 

both the lungs and liver of experimental 

animals characterized by eosinophilic 

infiltrates. Therefore, careful parsing 

of T-cell epitopes is much needed 

to prevent the presentation of TH17- 

inducing epitope elements increasing the 

chances of immune toxicity and disease 

susceptibility. 

The rapid technological advances 

Conclusion 

To conclude, a wide array of respiratory 

viruses induces severe pneumonia, 

bronchitis, and even death following 

infection. Despite this immense clinical 

burden, there is a lack of efficacious 

vaccines with long-term therapeutic 

benefit. Most current vaccination 

strategies employ the generation of 

broadly neutralizing antibodies. However, 

the mucosal antibody response to many 

respiratory viruses is short-lived and 

declines with age. In contrast, several 

studies on respiratory viruses have 

shown the presence of robust virusspecific 

CD8-T cell responses which 

has been shown to last for decades. 

Therefore, vaccine designs for emerging 

respiratory viruses need consideration 

and rational inclusion of CD8 epitopes 

to confer long term resistance. The 

OncoPept platform developed at 

MedGenome combines computational 

and experimental methods to mine 

strong CD8 immunomodulatory 

antigens with therapeutic utility across 

disease areas spanning respiratory and 

other infectious diseases, cancer, and 

autoimmunity. 

Contributed by OncoPept Team: Papia 

Chakraborty, Vasumathi Kode, Coral 

Karunakaran, Kayla Lee, Tahira Khan, Keshav 

Bhojak, Athulya Ramesh, Sudheendra HV, 

Rekha Sathian, Ankita Srivastava, Malini 

Manoharan, Swapnil Mahajan and Amitabha 

Chaudhuri. 


win 

certificate 

of excellence 

in science 

writing 

Med-Science 

Essay Competition 

2019 

TOPIC: POLYGENIC RISK SCORES FOR PREVENTIVE HEALTH 

Entries invited from medical PG students 

Please send your 1000 WORDS essay to: 


Winners’ essays will be published in FUTURE MEDICINE

technology 

EDGE OF CYBERKNIFE 

ON BRAIN METASTASIS 

Advanced treatment methods using cyberknife may enhance the survival rate of 

patients with brain cancer 

DR ADITYA GUPTA 

The spread of cancer to the 

brain is one of the most feared 

complications of cancer therapy 

and also comes with significant 

mortality and morbidity. This 

phenomenon occurs when cancer 

cells travel through the bloodstream 

or the lymph system from the original 

tumour and metastasize to the brain. 

This is known as metastatic cancer. 

For example, breast cancer that has 

spread to the brain would be referred 

to as metastatic cancer and not 

primary cancer. 

According to Globocan 2018 report 

issued by International Association of 

Cancer Registries (IARC) — a World 

Health Organization (WHO) associate 

— over 28,000 new brain tumour 

cases are reported annually in India 

and around 24,000 patients lose 

THE EXACT LOCATION 

OF THE TUMOUR IS OFTEN 

WRONGLY DETERMINED. 

THIS OFTEN LEADS TO 

MISDIAGNOSIS 

their lives battling such deadly and 

cancerous tumours. 

Most people ignore the initial 

symptoms of this disease, such as 

headaches, vomiting, seizures etc. 

As the exact location of the tumour 

is often wrongly determined, this 

condition often leads to misdiagnosis 

that can even result in the death 

of the patient. However, such 

trends are gradually declining thanks 

to the improved treatment of such 

deadly tumours, improving survival 

rates. 

The following symptoms can be 

caused by brain metastasis, but many 

patients may experience additional 

THE TUMOUR 

BURDEN 

Brain and other nervous 

system cancer is the 10th 

leading cause of death 

for men and women worldwide. 

28,000 

new cases of brain tumour are 

reported annually in India every year 

24,000 

patients lose their lives 

battling brain cancer 

SOURCE: GLOBOCAN 2018 


complications caused by the original 

tumour and its related manifestation. 

Increased pressures within the skull: 

In most cases, the symptoms are 

caused by the expansion of lesions 

and increased ICP (intracranial 

pressure). The most common 

symptoms of ICP are headaches, 

vomiting and disturbances in 

consciousness. 

Headache: Headache is the initial 

symptom in more than half of the 

cases of brain tumour and this is faced 

by most of the patients at some point 

in their life. 

Vomiting: This is an occasional 

accompaniment with headaches. It 

is far more common in children. In 

children, this can be dramatic and 

forceful, and may be labelled as 

projectile in nature. 

Seizures: It is an uncontrolled 

electrical disturbance in the brain. 

It causes changes in the mental 

behaviour, movements and level of 

consciousness. These are almost 

associated with 35% cases of brain 

tumours. 

LUNG CANCER IS THE 

MOST COMMON SOURCE 

OF BRAIN METASTASIS IN 

MALES, WHEREAS IT IS 

BREAST CANCER IN FEMALES 

Specific neurological symptoms: 

Whereas headaches that alter mental 

status and seizures may be seen with 

tumours that occur in any part of the 

brain, some symptoms are associated 

with the tumours that occur in a 

specific location. These symptoms 

affect the side of the body opposite 

from the side where the tumour 

resides and may include different 

modalities of sensation such as 

tingling and motor changes. 

Spread of systemic malignancy 

Virtually any systemic malignancy can 

metastasize to the brain, but there are 

some which have greater tendency to 

do so. Melanoma, a type of skin cancer, 

is a case in point. Other cancerous 

tumours of the skin, breast, kidney 

and the colon can also metastasize to 

the brain. Some differences are seen 

in the types of primary malignancies 

responsible for metastasis of the brain 

in both the genders. In males, lung 

cancer is the most common source 

of brain metastasis whereas breast 

cancer is the most common source in 

females. 

Diagnosis 

Brain metastasis can be diagnosed 

with the following tests: 

CT/CAT scan: It can be done with or 

without injecting intravenous contrast 

and includes different views of the 

brain. CT scans are utilized as initial 

diagnostic tests. 

Magnetic resonance imaging 

(MRI): It makes a clear picture of the 

brain using powerful magnets and 

radio waves. With the addition of 

intravenous contrast agents, this has 

become the gold standard in testing 

and provides information about the 

location, size, characteristics and 

pressure effects of the tumour. 


PET Scan: Positron emission 

tomography (PET) scans can detect 

cancer, reveal the stage of cancer, 

show whether the cancer has 

spread, help doctors decide on the 

most appropriate cancer treatment, 

and give doctors an indication 

of the effectiveness of ongoing 

chemotherapy. They are also useful in 

finding out how effective the current 

treatment is. The biggest advantage 

of a PET scan, compared to an MRI 

scan or X-ray, is that it can reveal 

how a part of the patient’s body is 

functioning, rather than just how it 

looks. Medical researchers find this 

aspect of PET scans particularly useful. 

A CT or MRI scan can assess the size 

and shape of body organs and tissue, 

but cannot assess its function like the 

PET scan does. In other words, MRI or 

CT scans tell you what an organ looks 

like, while a PET scan can tell you how 

it is working. 

THE MAIN ADVANTAGE OF 

CYBERKNIFE RADIATION 

THERAPY IS THAT 

IT DIRECTLY ALTERS 

INDIVIDUAL DEPOSITS 

INSIDE THE BRAIN WITHOUT 

AFFECTING THE TISSUE 

FUNCTIONING 

Tissue diagnosis is crucial and may 

have already occurred if the patient 

has a previously known malignancy. 

It may be obtained by biopsy or 

removal at the site of the primary 

cancer. Besides this, a biopsy of the 

metastatic brain tumour is performed 

if the size is large and it is causing 

significant pressure effects. The tumour 

may be removed entirely to relieve 

the pressure while providing adequate 

tissue for diagnosis. 

Once a clear diagnosis of the 

tumour is obtained and the staging 

of the systemic cancer is completed 

and the patient’s medical condition 

stabilized, a multidisciplinary team of 

physicians will try to treat the tumour 

within the brain with the best possible 

treatment methods. 

Why cyberknife 

Treatment varies with the size and 

type of tumor, the primary site of 

malignancy — whether it is local or at 

multiple spots in the body, the general 

health of the individual and the 

presence of other medical problems. 

The goals of the treatment involve 

improving body functioning, controlling 

the cancer and its satellite tumours 

within the brain. 

Cyberknife is performed in a noninvasive 

manner on an outpatient 

basis. The therapy aims to pinpoint 

the exact location of the tumor in realtime 

using 3-D imaging techniques 

and to ablate the tumour without any 

cut marks. Its outcomes are superior 

to those of traditional methods of 

treatment. It also provides more 

comfort to the patient as it can be 

carried out in 1 to 5 sessions 30 

minutes each. 

The main advantage of cyberknife 

radiation therapy is that it directly 

alters individual deposits inside 

the brain without affecting brain 

functioning. Separately, Whole Brain 

Reserve Therapy (WBRT) is reserved 

for those unfortunate patients who 

have too many deposits to be treated 

with cyberknife or who prefer multiple 

cyberknife treatments. In fact, for 

the treatment of metastasis in cases 

such as melanoma, radiation therapy 

(cyberknife) may be the only option. 

The author is Director 

– Cyberknife, Artemis 

Hospital, Gurugram. 


clinical trials 

ACCESS TO IMMUNO-ONCO DRUGS 

India is a promising location for immuno-oncology trials 

DR ANJU GOPAN 

Immuno-oncology (IO) therapeutics 

are driving a transformational change 

in cancer treatment, mobilising the 

patient’s immune system against their 

cancer, and aimed at reducing toxicities. 

Substantial benefits have been observed 

with IO therapies for solid tumours – 

especially in advanced and metastatic 

cancers with limited treatment options 

– and these are increasingly being 

included in global cancer treatment 

guidelines as standard of care. 

Use of IO therapies – including 

immune checkpoint inhibitors – in clinical 

care and clinical trials for solid tumours 

are being increasingly considered. 

Need for improved access 

Indian patients also often lack low-cost 

access to IO therapies that are approved 

in US and European markets. Currently, 

while IO therapies are available in India – 

either on demand or on compassionate 

use grounds – cost and affordability 

remain a concern even for higher income 

groups (see Figure 1). IO therapy in India 

is only reimbursed by medical insurance 

for patients who have been approved, 

and when used in combination with 

chemotherapy. In future, it would be 

helpful if the reimbursement decisions 

of insurance companies could take 

account of multiple factors, including 

overall survival benefit, efficiency, value, 

drug approval status, magnitude of 

clinical benefit and improved quality of 

life. In India, monoclonal antibodies and 

immunotherapy will be covered from 

October 2020. 

Currently, an estimated 60-70% 

of patients must pay out of pocket for 

IO treatments, with 30-40% of cancer 

patients for whom IO therapy is an 

option receiving some financial support 

from organizations such as government 

agencies or via compassionate use 

programmes. 

Recent moves by the Indian 

regulatory authority to expedite the new 

drug development process and ease of 

access to clinical trials have potential to 

help address access issues, along with 

the availability of clear guidelines. 

Combination strategies for cancer 

treatment in India are also emerging, 

along with an ongoing quest to identify 

biomarkers to predict who will respond 

IN INDIA, THERE ARE 

MINIMAL CHALLENGES IN 

PATIENT RECRUITMENT FOR 

IO CLINICAL TRIALS FROM 

THE ETHICAL, REGULATORY 

AND INSTITUTIONAL REVIEW 

BOARD PERSPECTIVES 

IO THERAPY: 

CHALLENGES 

Potential issues faced for 

immunotherapy treatments in 

India as per KOLs 

Expensive 

Treatment 

Insurance 

Approval 

40% 60% 

to therapy. 

Access to clinical trials – another way 

to gain access to IO therapies – is also 

currently not available to the majority of 

cancer patients in India. This situation 

demands solutions. India should be 

included in major global IO trials, along 

with other APAC countries, including the 

many preclinical and clinical research 

studies underway in solid tumours. 

In addition to providing robust data 

on safety, efficacy, and treatment 

approaches, this would benefit India’s 

large cancer patient population. 

Trial recruitment challenges 

In India, there are minimal challenges 

in patient recruitment for IO clinical 

trials from the ethical, regulatory and 

institutional review board perspectives. 

Oncologists – including those involved 

in this advisory board meeting – have 

strong support teams available to 

coordinate clinical trial activities, along 

with access to a large pool of patients, 

many of whom would be interested in 

participating in trials. 

However, there may be challenges 

for potential participants in meeting 

inclusion criteria, due to elements such 

as comorbid conditions, the existence 

of infections, and ongoing steroid and/ 

or antibiotic use. Long-distance travel 

to clinical sites might also be a limiting 

factor. 

During biomarker testing, patient 

anxiety, lack of standardisation among 

laboratories, and small tissue samples 

are the commonest hurdles faced by 

treating oncologists. 

One approach to overcoming 

these challenges would be to create a 

central platform including details about 

oncology patients, treatment options, 

and clinical trial opportunities. This could 

take the form of a database, application 


CLINICAL TRIAL 

RECRUITMENT 

Challenges for recruitment in 

immunotherapy clinical trials in 

India as per adboard 

Logistics, location, financial 

Eligibility requirements 

(specify) 

Patient pool 

Team-Experience/adequate 

supporting team 

Local /institutional 

regulatory bodies 

DCGI-Regulatory 

Ethical 

2 

2 

2 

2 

0 1 2 3 4 5 

Number of KOLs 

3 

3 

3 

3 

5 

5 

5 

or registry, which could help to increase 

awareness among doctors and patients, 

thereby increase participation in clinical 

trial across India. 

There is a particular need to connect 

rural patients and hospitals with major 

tertiary urban oncology centres and 

principal investigators. 

Closing the gap 

The advisory board proposed several 

approaches to closing the gap 

between levels of access to IO trials and 

treatment in India and those in other 

countries: 

• Exploring and showcasing India’s 

capabilities in oncology clinical trials 

and treatment with global regulatory 

agencies and medical societies, 

focusing on areas such as the 

ethics committee, data quality and 

infrastructure, and highlighting the 

need for improved patient access. 

• Organizing continuing medical 

education (CME) events through 

bodies such as the Immuno- 

Oncology Society of India, advisory 

boards, and national and international 

conferences. 

• Establishing platforms to conduct 

regular training sessions for 

oncologists, researchers and site staff 

on IO treatments, guidelines, adverse 

event management, and conducting 

GCP-compliant clinical trials (including 

setting up robust quality assurance 

teams). 

• Developing structured treatment 

protocols for hospitals as a basis 

for research and high quality data 

collection. These should be frequently 

updated to include the latest global 

guidelines and recommendations. 

• Setting up a central registry platform 

for oncology patients, including 

updates on clinical trials and 

treatments, and educational materials 

for oncologists, researchers, site staff 

and patients. The goal will be to 

foster clinical trial participation across 

India. 

• Creating online awareness and mobile 

applications to educate patients and 

caregivers about recent advances and 

ongoing trials. 

• Discussions are underway 

between medical and government 

policymakers for immunotherapies 

to receive reimbursement coverage 

by insurance companies and for local 

government health policies which 

could be implemented in the near 

future for the benefit of patients. 

Conclusion 

Over the last decade, clinical data 

generated by Indian clinical sites have 

been used successfully to support 

drug approvals in the United States, 

European Union and elsewhere. 

India remains on track to become 

a major centre for clinical trials and 

should be routinely considered by 

international sponsors for global IO 

trials. Advantages of India as a base for 

such trials include: 

• An improved regulatory environment 

that is now streamlined, simple and 

structured 

• Numerous government-funded 

and private cancer hospitals and 

research institutes with state-ofthe-art 

facilities, which can support 

multi-centre clinical trials 

• Experienced and highly trained 

oncologists and other medical and 

surgical specialists 

• Trained English-speaking 

investigators and clinical trial staff 

• Potential as a highly cost-effective 

location for clinical trials 

• Prevalence and practice of globally 

accepted standards of care, 

which support conduct of clinical 

trials based on international 

protocols. 

The author is Medical Director-Oncology, 

Medical Science and Strategy Asia, IQVIA. 


CARE OF 

KERALA 

Kerala, beyond its outstanding demographic features, 

has always tried to excel in various other social and cultural 

aspects — including education and healthcare standards, 

supported by visionary policies of each succeeding 

government. The state is now trying to take another big leap 

in the field of medical value travel, leveraging its capabilities 

in both modern and traditional medicine. Future Medicine, 

India’s premium medical science news magazine, takes a 

glance into this new vision of the state through this special 

feature brought out on the occasion of the 2020 edition of 

Kerala Health Tourism.


Kerala to tap medical 

tourism leveraging modern, 

traditional medicine 

Kerala is uniquely positioned 

to tap medical value tourism 

leveraging its skillsets in both 

modern and traditional medicine. 

The state, which already attracts 

foreign tourists for the longest stay 

in the country mainly due to its 

unique demographic features and 

Ayurvedic wellness programmes, is 

also currently building its skillsets in 

modern medicine too with state-of 

the-art infrastructure and professional 

qualities. 

“Our demographic features 

already attract more foreign 

tourists and the state’s expertise in 

indigenous medicine also plays an 

important role in wooing travellers,” 

said K K Shailaja, the minister of 

health and social welfare, Kerala, 

speaking at the 9th edition of Kerala 

Health Tourism conference and 

exhibition organised by CII Kerla 

chapter. 

While emphasising the need for 

developing more Ayurveda medicine 

production centres with modern 

standards and quality in the state to 

make indigenous medicine better 

and more accessible to common 

people, she said Kerala also has 

the potential to emerge as a hub 

for modern treatment going by our 

globally known professional skillsets 

in modern medicine and also the bestin-class 

medical infrastructure being 

built in the public as well as private 

sector. 

While making the opening remarks 

at the Kerala Health Tourism-2020, 

Thomas John Muthoot, Chairman, 

CII-Kerala, stressed on the importance 

and value of promoting medical value 

tourism. The hospital industry in India 

— accounting for 80% of the total 

healthcare market — is witnessing 

a huge investor demand from both 


global as well as domestic investors. 

The state is expected to have a 

substantial role to play in India’s future 

growth in the healthcare services 

industry. According to latest Invest 

India Report, the hospital industry is 

expected to reach $132 billion by 2023 

from $61.8 billion in 2017; growing at a 

CAGR of 16-17%. 

According to Muthoot, the 

medical tourism segment of Kerala’s 

tourism industry is proliferating at 

a faster pace and has become an 

excellent brand by itself in the health 

tourism mainly because of its repute 

in modern as well as traditional 

systems of treatment and their cost 

effectiveness. 

“The quality of healthcare offered 

by the doctors, nurses and support 

staff, make medical tourism in Kerala 

a preferred choice for patients seeking 

healthcare solutions in India,” he 

added. 

Kerala state chief secretary Vishwas 

Mehta recalled that the longest stay 

by tourists travelling to India has been 

in Kerala and the reasons for that 

Our demographic 

features already 

attract more foreign 

tourists and the 

state’s expertise 

in indigenous 

medicine also 

plays an important 

role in wooing 

travellers. 

K K SHAILAJA 

Minister, Health and social 

welfare, Kerala 

could be health tourism, leisure and 

recreation. 

While there are concerns about 

lack of adequate attention from 

the State administration in terms 

of encouraging medical tourism, 

the minister said that; “Ideally, 

there should be a separate entity in 

the government that can work in 

collaboration with health and industry 

departments to promote medical 

value travel in the state and we need 

effective discussions on this between 

various stakeholders, including the 

private and public health services 

industry.” 

The minister was replying to 

concerns raised by noted healthcare 

entrepreneur Dr M I Sahadulla, chair, 

CII Kerala Healthcare Panel and 

Convenor of KHT-2020, about the 

absence of a government department 

directly responsible for promoting 

medical tourism in the state as it 

neither falls under the industry 

department nor comes into the 

priority focus of tourism ministry at 

present. 



STATE MODEL OF COVID 

MANAGEMENT: 

STRATEGIES AND 

CHALLENGES 

N. S. Arunkumar 

In October 2020, there was an 

election victory which was also 

hailed as a victory over the coronavirus. 

Yes, it was a wonder, when the sitting 

Prime Minister of New Zealand, Jacinda 

Ardern was re-elected, as it was under 

her leadership, New Zealand became 

one among the lowest per capita 

COVID-19 cases in the world. To date, 

it has had 12 deaths, and each infected 

person is passing the virus to fewer 

than one other person. And, people 

admired Jacinda by giving her one 

more chance! 

Kerala has many parallels with 

New Zealand. In the late 1970s to 

the early 1990’s, the state of Kerala 

experienced financial crisis owing to 

globalization and economic reforms 

in the national level. Along with the 

flourishing privatisation in all fields, 

there happened an exponential 

growth of private healthcare sector 

causing a deterioration in the 

quality of healthcare. But this created 

a large mass of people without any 

access to quality healthcare as well 

as a great majority without any 

affordability to it. 

Hit by the pandemic 

It will be a surprising fact that it was 

in Kerala, the first case of COVID‐19 

in India was detected on January 30, 

2020. It was a student returning from 

Wuhan, China who tested positive for 


RNI Number KERENG/2012/44529 Registered No. KL/KTM/146/2020-22 Future Medicine 

August 2020


COVID‐19. But, within a short period 

of time, the ‘Kerala Model’ emerged 

as a success story worthy enough to 

be mentioned by the World Health 

Organization. The firmly rooted public 

health system, high literacy rate, 

the unique socio-cultural fabric, the 

existence of a strong political will are 

some of the factors that played a key 

role. 

Public health measures 

Kerala’s experience of having dealt with 

an infectious disease outbreak like 

Nipah, equipped it with the knowledge 

to deal with the novel coronavirus 

infection. The following are the 

measures Kerala undertook. 

1. Early diagnosis and contact tracing 

– Everyone coming from abroad 

was asked to stay under home 

quarantine. A route map of patients 

who tested positive for COVID-19 

was created and published through 

news agencies to find any missed 

out contacts. 

2. Social distancing, quarantine and 

self-isolation – Social distancing 

was well practiced. A campaign on 

social distancing called “Break the 

Chain” was initiated by the Kerala 

government to deliver the message 

of social distancing. Masks were 

made compulsory. 

KERALA’S EXPERIENCE 

OF HAVING DEALT WITH 

A NIPAH OUTBREAK, 

EQUIPPED THE STATE 

WITH THE KNOWLEDGE 

TO DEAL WITH THE 

NOVEL CORONAVIRUS 

INFECTION 

3. Lockdown – Kerala implemented 

lockdown on 23 March, 2020 

two days before lockdown was 

announced for the whole of 

India. All schools and colleges 

except for medical colleges were 

closed. All inter-state, 

inter-district, international travel 

was stopped. 

4. Compulsory testing - On an 

average, around 500 tests were 

conducted every day. The number 

of testing kits were in short supply 

especially after the disease 

reached wealthier western 

countries. Also, all pneumonia 

cases reported in private and 

government hospitals were tested 

for COVID-19. 

5. Strict border screening - Multiple 

teams were deployed at multiple 

border points, every vehicle was 

monitored, details of passengers 

were collected and their body 

temperatures were recorded. This 

was also done at railway stations 

and airports. 

6. Sentinel Surveillance System – A 

Sentinel Surveillance System as 

mandated by WHO, was used which 

included random testing done 

using RT-PCR test. Testing was done 

in general population with acute 

respiratory infection as well as for 

healthcare workers. 

7. Standard health care for COVID 

patients - A guideline for treatment 

of COVID-19 patients was created 

early on. The guidelines had 

specifications for various categories 

of patients based on severity 

and was made available through 

the DHS (Directorate of Health 

Services) website. 

8. Promoting respiratory and hand 

hygiene in the community – ‘Break 

the chain’ campaign was launched 

by the Kerala government on 

March 15, 2020 and as a part of this 

campaign, all public spaces were 

asked to keep hand sanitizers, soap 

and water at the entrances. 

8. Proactive care to elderly 

and vulnerable individuals 

– Kudumbashree, the statewide 

women’s empowerment 

programme, was utilised to initiate 

community kitchens. A helpline 



called the Prashanti Help Line was 

launched by the Kerala police for 

the welfare of senior citizens during 

the pandemic. 

9. Management of guest workers – 

Local police was used to identify 

all dwellings of the guest labourers. 

Every camp was provided with a 

home guard having knowledge 

of Hindi/Oriya/Bengali to 

communicate effectively with the 

labourers. 

10. Care of healthcare workers- The 

state government prepared ahead 

to ensure adequate availability 

of PPE kits for frontline workers. 

Kiosks were setup for healthcare 

workers to collect nasopharyngeal 

swabs without using PPE. 

Implementation of public health 

measures 

The state coordinated various 

strategies through the district control 

rooms. The district control room 

in turn communicated with each 

panchayat who are in touch with the 

frontline workers. The district control 

unit maintained data of all those under 

home quarantine. 

a. COVID Hospitals- These are 

dedicated hospitals that cater 

to severe or critical COVID-19 

patients. There are 28 COVID 

hospitals in the state, with two for 

each district. Infection controls in 

hospitals were rigorously enforced. 

b. COVID First Line Treatment Centres 

- These centres were set up to 

manage any sudden outbreak of 

COVID-19 in any local area. All mild 

and moderate cases are treated in 

these centres and severe cases are 

referred to COVID hospitals. 

c. COVID Care Centres – These were 

established with the aim of taking 

care of people like tourists, those 

in-transit etc. These centres provide 

independent single rooms with 

attached toilets. Food also was 

provided. 

d. COVID Cell - COVID cells were set 

up with health department as the 

nodal institution. These cells are 

the hub of all the activities in the 

institution and led by persons with 

decision making and implementing 

capacities. 

Use of Ayurveda during Covid-19 

The Kerala government had decided 

to integrate Ayurveda into the 

management of COVID-19, much 

earlier. ‘Ayur Raksha’ clinics were 

started at government hospitals at 

district and taluk levels. 

Challenges in COVID management 

in Kerala 

Though Kerala’s efforts to prevent 

the community spread stage of the 

COVID-19 received worldwide acclaim, 

THE LESSONS GAINED 

FROM THE KERALA SHOW 

THE IMPORTANCE 

OF TRANSPARENCY, 

PEOPLE’S INVOLVEMENT 

AND LOCAL AUTONOMY 

IN EFFECTIVE 

MITIGATION OF THE 

DISASTERS 

in the latter half of 2020, the state has 

seen a surge in COVID-positive cases. 

The following drawbacks are cited as a 

reason for this setback: 

1. Low testing rate 

Experts believe that the health 

administration system failed to 

conduct enough tests to identify the 

COVID-positive cases and so there 

were many hidden cases leading to 

‘community spread’ level of explosion 

of the pandemic across the state. 

2. Inappropriate testing method 

Experts from the technical field opine 

that there was also an another strategic 

mistake in opting for antibody testing, 

which was actually a waste of time and 

resources. Antigen assay would have 

been more appropriate as it has more 

sensitivity and good specificity. Even 

then, if there is a clinical suspicion, 

the doctor could ask to get the RT-PCR 

done. 

3. Infrastructure-medical staff ratio 

Though there were First Line Treatment 

Centres (FLTCs) even in Panchayats, 

there were not enough doctors and 

nurses. This was because the healthstaff 

were deployed in secondary 

and tertiary care centres or hospitals. 

There was also no timely updating 

on the availability of ICU beds with 

ventilators. 

4. Lack of capacity building 

Doctors were exclusively mandated for 

collecting swabs for testing. Training 

nurses to collect swabs could have 

saved time. The state felt a an acute 

shortage of man-power and only a 

few were applying for the contract 

jobs under the state National Health 

Mission due to low wages. 

5. Keeping private hospitals away 

Keeping the private hospitals away 

from COVID-care was yet another 

strategic error. Presently, the patients 

reaching Primary Health Centres have 

to be transported to taluk or district 

hospitals to have their swabs collected 

for testing. This is a serious lapse in 

capacity building. 

Mitigation: The people model 

All the success of the Kerala model 

so far are seen to be context-specific. 

Although all of the measures taken 

may not be replicable in other parts 

of the world, the lessons gained from 

the Kerala show the importance of 

transparency, people’s involvement 

and local autonomy in effective 

mitigation of the disasters due to the 

disease. 


EXCELLENCE IN 

HEALTHCARE STANDARDS 

As observed by Richard Franke 

and Barbara Chasin in the book 

‘Radical Reform as Development in an 

Indian State’, Kerala’s health care is a 

popular demand that the government 

is compelled to meet. Anthropologist 

Joan Mencher, who has worked in 

Kerala and other parts of India for 

thirty years, sums up the situation as 

follows: “In the nearby Indian state of 

Tamil Nadu, more than half the times I 

visited a Primary Health Centre (PHC), 

one doctor was on leave, another was 

attending a conference, or one doctor 

had just been transferred and another 

was off on some training programme, 

or had gone to see his or her sick 

mother, etc. This was not the case in 

Kerala”. 

Health care as a public demand 

Right from the time of formation 

of the state, health care was one of 

the governments’ top priorities. It 

was developed in such a way that 

it incorporated both Western and 

traditional medicine and the three 

categories in view of its ownership: 

public, private and cooperative sector. 

Allopathic facilities of the public sector 

are systematically organized in rural 

areas, where 74% of the population 

resides. Each Community Health 



Centre serves roughly 230,000 people, 

and each PHC serves a population of 

approximately 26,000. In addition, 

there are 5,094 sub-centres of PHCs as 

grass root institutions. 

Public health programmes 

in Kerala 

Kerala has made its own hallmarks 

through its accomplishments in both of 

these areas. At the same time, the point 

to note is that, the gains in health are 

not the product of health programmes 

alone, but due to the combined effects 

of the various reform programmes 

planned and executed by the state 

government. Kerala’s public health 

efforts are seen to be concentrating on 

four areas: housing, sanitation, safewater, 

and vaccination programs. 

Housing and living standard 

Poor housing can be a major source 

of disease. Dirty floors and palm roofs 

attract bacteria and mosquitoes. 

Overcrowding exacerbates the spread 

of infections and parasites. In order to 

provide quality housing options to the 

underprivileged sections of society, 

the Kerala government has unveiled 

a Livelihood Inclusion and Financial 

IN A SIGNIFICANT 

ACHIEVEMENT, 

KERALA HAS 

BROUGHT ITS INFANT 

MORTALITY RATE, 

DOWN FROM 

10 TO THE SINGLE DIGIT 

OF 7 

(PER 1,000 LIVE BIRTHS) 

Empowerment (LIFE) programme. 

The LIFE Mission is a housing scheme, 

to provide shelter to landless and 

homeless people in Kerala. The target is 

to build 4.3 lakh homes in five years. 

High sanitation standard 

Improving sanitation has been 

an activity of the government of 

Travancore (southern Kerala) since the 

late nineteenth century. Construction 

of safe latrines was also set as a 

goal, but progress has been much 

slower. Kerala Sanitation Policy, an 

integrated action plan, the Malinya 

Mukta Keralam, was drawn up for a 

comprehensive intervention in the 

sanitation situation in Kerala. The 

action plan, which was released by the 

President of India on 1st November 

2007, put forward an overall strategy 

to make Kerala waste free, with an 

unpolluted environment, public 

hygiene and cleanliness. 

Access to clean water 

Water scarcity is a serious problem 

in India, but it is not as much as 

serious in Kerala compared to other 

states. All the habitation in Kerala has 

achieved above 40 litre per capita per 

day. In order to assure the quality of 

water resources in Kerala, Centre for 

Water Resources Development and 

Management (CWRDM) implements 

a project Establishment of Mobile 

Testing Laboratory for the Quality 

Assurance of Water Resources in Kerala 

with the support of Water Resources 

Department, Government of Kerala. 

Services of the mobile laboratory 

was extended to approximately 120 

panchayaths, 15 municipalities and 

three corporations. 

100 percent immunization 

Preventive immunization and 

vaccination are Kerala’s most 

impressive public health programmes. 

By 1970, smallpox was entirely 

eradicated, making Kerala the first state 

in India to achieve that goal. In 1976, 

Kerala’s malaria rate per thousand was 

zero, compared to the all-India average 

of eleven. Recently, in February 2018, 

the Kerala government introduced 

a draft health policy that has made 

vaccination compulsory for school 

admissions. It was to ensure that all 

children below the age of five years are 

fully vaccinated. 

Low infant mortality rate 

The urban parts of Kerala were 

reporting a decline in the IMR 

from 174 in 1997 to 9 in 2012. In 

a significant achievement, Kerala 

has brought its infant mortality rate, 

down from 10 to the single digit of 

7 (per 1,000 live births), according 

to the latest Sample Registration 


System bulletin which was released 

in May 2020. This means that Kerala 

has achieved the UN’s Sustainable 

Development Goals target for IMR 

reduction, set at eight for the year 

2020. Kerala is also the only state to 

have achieved the single digit IMR of 7 

amongst bigger states, the closest being 

Delhi with an IMR of 13. 

Low birth rate 

One of Kerala’s most impressive 

achievements has been the dramatic 

decline in birth rates. India’s birth 

rate declined by 0.2 points with 

Kerala registering the lowest in 2013, 

according latest official data. The Crude 

Birth Rate (CBR) at the national level 

during 2013 stands at 21.4, a decline 

of 0.2 points over 2012. The maximum 

CBR has been reported in Bihar (27.6) 

and the minimum in Kerala (14.7), as 

per the Sample Registration System 

(SRS) survey. The survey further said 

there has been a decline of 1.4 points 

in the CBR for the country from 2008 

to 2013. 

Life expectancy 

Kerala’s life expectancy continues 

to remain very much above the all- 

India figure, so we must assume that 

general health facilities continue to be 

widely available. Kerala’s rural hospital 

beds per 100,000 rose from 107 in 

1980 to 192 in 1990, a 79% increase. 

Kerala’s child tuberculosis, polio, and 

DPT (Diphtheria-Pertussis-Tetanus) 

vaccination rates in 1992 were 100%. 

The all-India rate for DPT was 83%. 

For measles, Kerala’s rate was 92%, 

compared to an all-India rate of 77%. 

Since 1980, Kerala has overtaken the 

rest of India and in 2001 the proportion 

of the old age population rose to 10.5 

per cent as against all India average of 

7.5 per cent. 

Nutrition 

Because of the high levels of education 

and awareness, Kerala mothers nearly 

always breast feed their children 

for at least the first six months. To 

fight malnutrition among children 

in the state, the government of 

Kerala has launched a nutrition bar 

named ‘Thenamruth’, which was 

created jointly by the Department 

of Women and Child Development 

(WCD). The supplement is developed 

as a part of WCD’s Department’s 

Sambushta Keralam (nutrient-rich 

Kerala) project. It complies with the 

dietary requirements of a child as 

recommended by the Ministry of 

Health and Family Welfare (MoHFW) 

and the World Health Organisation 

(WHO). 

Cancer and occupational 

health paradox 

As Amartya Sen, one of India’s most 

renowned economists argued, these 

data are hard to reconcile with the fact 

that Kerala’s people live longer and the 

children are so much less likely to die. 

Occupational health and safety are 

virtually undeveloped in Kerala. The 

state Minister for Health and Family 

Welfare K K Shailaja on July 2, 2019, 

informed the Kerala assembly of the 

alarming increase in the number of 

cancer patients in the state. 

As per the stats, government 

hospitals had registered 57,727 new 

cancer cases between 2018-19. Studies 

are being undertaken at the RCC in 

association with ICMR to establish 

the reasons behind the rise in number 

of cases. 

New policy on health 

As the new Left-led government 

was sworn in, in 2016, following the 

Sustainable Development Goals of the 

United Nations, policies were enacted 

to provide quality healthcare to all 

citizens at affordable cost. The ‘Ardram 

Mission’ was conceived with the aim 

of providing health care with a touch 

of humanity to all people. Thus the 

healthcare became people-centred and 

people-friendly rather than doctorcentred. 

Under the ‘Ardram Mission’, 

the PHCs in the State was converted to 

Family Healthcare Centres. The state 

cabinet also approved Kerala’s new 

health policy on 24th January 2019. The 

new Health Policy 2018 aims to provide 

universal, affordable and quality health 

care for everyone. 


guidelines slug 

GUIDELINES ON SAFE 

OPHTHALMOLOGY 

PRACTICES IN COVID-19 

SCENARIO 

The examination & procedures 

related to ophthalmology involves 

close interactions with the patient. 

This document outlines the preventive 

and response measures to be observed 

to minimize and avoid the spread of 

COVID-19 in eye care facilities. 

SCOPE 

These guidelines are aimed to minimize 

the spread of Covid-19 infection 

among Ophthalmologist, Ophthalmic 

assistants/technicians, nurses, support 

staff, patients and their attendants. Eye 

care facilities in containment zones 

shall remain closed. Only those outside 

containment zones will be allowed to 

open up. 

BASIC PREVENTIVE MEASURES 

Persons above 65 years of age, persons 

with comorbidities, pregnant women 

and children below the age of 10 years 

should be encouraged to stay at home, 

unless they are patients themselves. All 

eye care facilities may advise all visitors/ 

staff/patients accordingly. 

The basic preventive measures 

include simple public health 

measures that are to be followed 

to reduce the risk of COVID-19. 

These measures need to be 

observed by all (patients, staff 

and visitors) in these places 

at all times. 

• Physical distancing of 


at least 6 feet to be followed as far as 

feasible. 

• Use of face covers/masks to be made 

mandatory. 

• Practice frequent hand washing with 

soap (for at least 40-60 seconds) 

even when hands are not visibly dirty. 

Use of alcohol-based hand sanitizers 

(for at least 20 seconds) can be 

made wherever feasible. 

• Respiratory etiquettes to be strictly 

followed. This involves strict practice 

of covering one’s mouth and nose 

while coughing/sneezing with a 

tissue/handkerchief/flexed elbow and 

disposing off used tissues properly. 

• Self-monitoring of health by all and 

reporting any illness at the earliest to 

state and district helpline. 

ALL EYE-CARE FACILITIES SHALL 

ALSO ENSURE THE FOLLOWING: 

Tele-counselling and teleconsultation 

should be encouraged to lessen patient 

visits and/or appointment system can 

be followed to call patients needing 

examination/eye investigations/ 

procedures 

• The screening of patients for Cataract 

and other eye diseases in outreach 

areas may be undertaken only after 

duly following social distancing, hand 

hygiene and personal protective 

measures. Remote consultations by 

the NGOs in vision centres is also 

to be encouraged. The identified 

patients may be called to the base 

hospital by appointment for cataract 

surgery, so that backlog of cataract 

does not build up. 

• No eye ball retrieval from homes to 

be undertaken, only Hospital Cornea 

Retrieval Program can be continued 

in non-Covid-19 cadavers, for 

utilization of corneas for therapeutic 

purposes only. 

• Specific markings may be made with 

sufficient distance to manage the 

queue and ensure social distancing in 

the premises. 

• Entrance to hospital/clinic to have 

mandatory hand hygiene and thermal 

screening provisions 

• The staff manning these entry points 

NO EYE BALL RETRIEVAL 

FROM HOMES TO BE 

UNDERTAKEN, ONLY 

HOSPITAL CORNEA 

RETRIEVAL PROGRAM 

CAN BE CONTINUED IN 

NON-COVID-19 CADAVERS 

should ensure appropriate personal 

protection as entailed in guidelines 

already issued. (available at: 

• The patients should be queried about 

Covid-19 like symptoms and contact 

history. 

• A daily list of all HCW, patients and 

their attendants & any hospital 

visitors with their mobile numbers 

and IDs should be maintained (for 

contact tracing if needed in future) 

• For preliminary screening of 

patients, the flow chart as attached 

in Annexure-I should be followed 

and patient should be examined 

accordingly 

• Posters/standees/AV media on 

preventive measures about COVID-19 

to be displayed prominently 

• Any shops, stalls, cafeteria etc., 

outside and within the premises shall 

follow social distancing norms at all 

times. 

• Number of people in the elevators 

should be restricted, duly maintaining 

social distancing norms. 

• For air-conditioning/ventilation, 

the guidelines of CPWD shall be 

followed which emphasizes that 

the temperature setting of all air 

conditioning devices should be in the 

range of 24-30 o C, relative humidity 

should be in the range of 40- 70%, 

intake of fresh air should be as much 

as possible and cross ventilation 

should be adequate. 

• Effective and frequent sanitation 

within the premises shall be 

maintained with particular focus on 

lavatories, drinking and hand washing 

stations/areas. 

• Proper disposal of face covers / 

masks / gloves left over by visitors 

and/or employees should be ensured 

in the premises, in accordance with 


the Bio-Medical Waste Management 

Rules. 

• Encourage app-based mobile phone 

check in & payment along with digital 

prescription of glasses and medicines 

to prevent long queues 

Protocols for OPD Services 

• Promote digital or app-based 

registration system. 

• Triaging by an ophthalmologist/ 

trained ophthalmic personnel may 

be done either through telephonic 

conversation to determine the 

emergency/non-emergency nature of 

the eye problem and Covid-19 status 

of the patient and an appointment 

given accordingly to avoid rush of 

patients. 

• Emergency cases as listed at 

Annexure-II should be given priority. 

• Only one Attendant is to be allowed 

with one patient. 

• Social distancing of at least 6 feet 

to be followed at all times as far as 

feasible in the queue or in doctor’s 

chamber. 

• Modify process flow (like 

unidirectional flow of patients) in 

TRIAGING BY AN 

OPHTHALMOLOGIST 

PERSONNEL MAY BE DONE 

THROUGH TELEPHONIC 

CONVERSATION TO 

DETERMINE THE NATURE OF 

THE EYE PROBLEM 

OPD to minimize people’s movement 

inside the premises and also to 

reduce time spent during the hospital 

visit 

• Seating arrangement to be made in 

such a way that social distancing is 

maintained. 

• OPD premises should be disinfected 

with 1% hypochlorite frequently and 

after all the patients have been seen. 

• Cleaning and regular disinfection 

(using 1% sodium hypochlorite) of 

frequently touched equipment such 

as Trial Frame, Trial Lenses, etc. used 

in the OPD must be ensured. 

• The chinrest/headrest/table top 

etc. of equipment must also be 

disinfected after each patient is seen. 

• Equipment like slit lamp should have 

a Plexiglas/breath shield to avoid 

contact with droplets from patient’s 

breath. This sheet should also be 

disinfected after seeing any patient. 

• While performing any contact 

procedure like Tonometry, Gonioscopy, 

Keratometry, A- Scan, B-Scan, UBM, 

OCT, FFA etc., the instruments should 

be cleaned with 70% alcohol swab, 

before and after every new case. 

• Eye drops should be put in 

the patient’s eye by a nursing/ 

paramedical staff with a no touch 

technique (ask the patient to pull 

down his/her lower lid or pull it down 

with a swab stick) 

Protocols for Ward 

• Patients and attendants should be 

screened before entering the wards. 

• Only one attendant per patient can 

be allowed. 

• Patients to be kept in the ward duly 

maintaining adequate distancing. 

• Regular sanitization of ward (with 1% 

sodium hypochlorite solution) should 


PATIENT FLOW CHART 

Patients attending ophthalmology clinic 

Screen for fever, Covid-19 like symptoms, contact and/or travel history 

Yes 

Ocular emergency 

No 

See the patient in regular ophthalmology clinic with 

routine universal precautions 

Yes 

No 

Designated 

ophthalmologist & clinic 

staff equipped with 

personal protective gear 

to see the patient in 

a designated isolated 

examination room 

Refer the 

patient for 

medical care 

be done frequently at least twice in 

a shift. Instrument sterilization after 

seeing each patient needs to be done 

as per the manufacturer’s protocol. 

• In case a Covid-19 patient with 

Eye condition is to be admitted, a 

separate room or an isolation ward 

should be used 

Protocols for OT Services 

• Pre-surgical Covid-19 test on patients 

is not mandatory, but a thorough 

history taking & examination must 

be done to ensure that patient has 

minimal probability of having COVID 

infection. 

• No routine procedure/surgery to be 

done in a Covid-19 suspect/confirmed 

case. 

• Appropriate PPE as per MOHFW 

guideline should be worn by OT staff. 

• The OT tables, floor and equipment 

should be properly disinfected after 

each use. 

Protocols for Hospital Staff 

• The duty roster of all HCWs including 

doctors, nurses and paramedical 

workers should ensure effective 

social distancing. 

• Inform your immediate superior if 

you develop any symptoms/signs of 

COVID like infection. 

In case of a suspect or confirmed 

case in the premises, the protocols for 

attending to suspect or confirmed case 

and disinfection available at: https:// 

www.mohfw.gov.in/pdf/ Guidelines on 

preventive measures to contain spread 

of COVID19 inwork place settings. shall 

be followed. These include: 

• Place the ill person in a room or area 

where they are isolated from others. 

• Provide a mask/face cover till such 

time he/she is examined by a doctor. 

• Immediately inform on premise 

nodal officer and the state or district 

helpline. 

• A risk assessment will be undertaken 

by the designated public health 

authority (district RRT/treating 

physician) and accordingly further 

action be initiated regarding 

management of case, his/her 

contacts and need for disinfection. 

• Disinfection of the premises to be 

taken up if the person is found 

positive 

EMERGENCIES IN 

OPHTHALMOLOGY PRACTICE 

Urgency in eye cases is determined 

by the potential risk to vision, Eye & 

life and impact on the quality of life if 

left untreated. Based on these criteria 

the Ocular Emergencies are listed below: 

• Injury to the eye (chemical, thermal, 

mechanical) 

• Sudden loss of vision 

• Acute pain in the eye 

• Acute red eye 

• Acute onset of eyelid lesions 

• Acute onset of double vision or sudden 

onset of drooping of the eyelid 

• Acute onset of coloured halos, 

photophobia, floaters or flashes of light 

• Acute onset of discharge from the eye/ 

eyes 

• Acute or subacute (days to weeks) 

onset of bulging of the eye 

• Retinal Detachment, Retinal Tear, 

Fresh CNVM, Viral Retinitis, intraocular 

Infection, Non traumatic perforation of 

Eyeball even in absence of vision loss. 

Source: Ministry of Health and Family Welfare, 

Government of India 


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Upcoming conferences 

NOVEMBER 

2-3 IMMUNOLOGY 

36th International Conference on 

Investigating Advancements in 

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5 CARDIOLOGY 


Clinical & Experimental Cardiology 


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11th Euro Breast Cancer and 

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5-6 RARE DISEASES 

4th Annual Summit on Rare 

Diseases and Orphan Drugs 

https://rarediseases. 


9 IMMUNOLOGY 

2nd World Conference on Vaccine 

and Immunology 

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9 NEUROCARDIOLOGY 

3rd World Heart and Brain 

Conference 

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3rd World Heart Rhythm 

Conference 

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9-10 DIABETICS 

International Congress and Expo 

on Diabetic Care 

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com/ 


26th International Conference 

on Cardiovascular and Thoracic 

Surgery 



9-10 DIABETES 

International Congress and Expo 

on Diabetic Care 

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com/ 


Global Heart Summit 

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11-12 PAEDIATRICNEUROLOGY 

4th World Congress on Pediatric 

Neurology and Pediatric Surgery 

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neurologyconference.com/ 

12-13 OPHTHALMOLOGY 

European Conference on 

Ophthalmology & Eye care 

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ophthalmologyconferences.com/ 

16-17 ONCOLOGY 

International Conference on 

Frontiers in Lung Cancer 

https://lung-cancer.cancersummit. 

org/ 

16-17 DIABETES 

World Congress and Expo on 

Diabetes 

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com/ 


11th Asian Breast Cancer: 

Screening, Treatment & 

Management Summit 

https://breast.cancersummit.org/ 

16-17 MICROBIOLOGY 

7th International conference on 

Parasitology, Microbiology and 

Infection Control 

https://parasitology. 


18-19 ANAESTHESIA 


Anesthesia 

https://anesthesia. 

insightconferences.com/ 



Immunology & Immunotherapies 

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18-19 ENDOCRINOLOGY 

Annual congress on Diabetes and 

Endocrinology Congress Webinar 

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endocrineconferences.com/ 



Cancer Stem Cells 

https://cancerstemcells. 


23-24 INFECTIOUS DISEASES 


Emerging Infectious Diseases 

https://emerging-diseases. 

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23-24 RARE DISEASES 

Global Summit on Rare Diseases 

and Medicine 

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35th European Cardiology 

Conference on COVID-19 and 

Current perspective on heart 

treatment 

https://cardiologyconference. 




European Immunology 

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Complications in COVID-19 

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DECEMBER 

3-4 PAEDIATRICS 

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https://pediatric. 


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COVID-19 Vaccines Webinar 

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The announced dates of the conferences may change 


January 2020 / FUTURE MEDICINE / 19

LEARN TO SAVE 

THE GOLDEN HOURS 

DR SAMIR PAREKH 

Neurosurgeon, Apex Superspecialty Hospitals, Mumbai 

A 

stroke is a medical emergency as it can lead to 

death or permanent disability. Though there are 

many modern treatments available for brain 

disorders in India today, stroke alone kills as many as 

7 lakh Indians every year due to delayed treatment. More 

often, this delay is caused by one reason: a failure to 

identify the disease. While we can’t expect the common 

man or non-medical people to have the skill-set to avoid 

this mistake, natural delays like mistaking the patients’ 

symptoms by family members or onlookers for other nonemergency 

issues, wasting time on home remedies, traffic 

blocks, long distances from home or an accident location 

to the nearest doct and so on are always a possibility 

before the patient finds urgent medical care. But the 

most unacceptable part is the delay within the medical 

setup due to the non-identification of the symptoms or 

mishandling of the case, even after the patient is brought 

there on time. As we all know, providing timely medical 

care is critically important in case of stroke and only that 

can save the patient’s life. Hence, saving the golden hours 

of the patient is primarily the responsibility of you and 

me, as we are in the profession of care. 

A brain stroke can have many causes, including 

heredity. Stress, lack of exercise, constant drinking 

and smoking can also contribute to the disease. The 

symptoms of stroke include paralysis, numbness or 

weakness in the arm, face, and leg, especially on one side 

of the body, trouble in speaking or understanding speech, 

confusion, slurring speech or vision problems such as 

trouble seeing in one or both eyes with vision blackened 

or blurred or double vision, trouble walking, loss of 

balance or coordination, dizziness and severe and sudden 

headaches of unknown cause. 

At the onset of the disease, headaches and dizziness, 

or frequent dizziness, need to be treated immediately 

with the advice of a neuro expert. So, there shouldn’t be 

any delay in action once you identify the symptoms. From 

the onset of the symptoms, there is only a 3-to-4.5-hour 

window to use clot-busting drugs or a 6-hour window 

to do a mechanical thrombectomy (if needed). So, 

identifying the disease at the earliest and enabling the 

right medical intervention with the help of a specialist (in 

person or through telemedicine) is very critical. However, 

understanding this criticality and saving these golden 

hours is more crucial to save a life. Getting ourselves 

prepared to deal with this emergency and making 

the public too aware of the criticality of stroke is our 

responsibility. 


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RNI Number KERENG/2012/44529 Registered No. KL/KTM/146/2020-22 Future Medicine 

November 2020

FM November2020 Digital P

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