Leveraging Public Private Partnerships to Address Global Vaccine ...

The Woodrow Wilson School’s Graduate Policy Workshop 

Leveraging Public Private Partnerships to Address 

Global Vaccine Needs 

Evaluation of the Merck-Wellcome Trust Hilleman Laboratories 

Siddharth Chatterjee, Erica Frenkel, Gastón Gertner, 

Hope Glassberg, Amy Lin, Talal Mir, Chloe Poynton, Mark Roland, 

Elie Teichman, Ben Tiede 

Advisor: Professor Adel Mahmoud 

January 2011

• Dr. Neeraj Aggarwal, Group Leader, 

Vaccines at Biopharmaceutical Research 

Centre, Panacea Biotech, New Delhi, India 

• Dr. Peter Agre, Nobel Laureate, Director 

of the Johns Hopkins Malaria Research 

Institute 

• Dr. Ted Bianco, Director of Technology 

Transfer, Wellcome Trust, London, U.K. 

• Dr. John Clemens, Director General, 

International Vaccine Institute, Seoul, South 

Korea 

• Dr. Cecil Czerkinsky, Deputy Director 

General, Laboratory Science Division, 


Korea 

• Dr. Albinus D’Sa, Deputy Director, India 

Office, US Food and Drug Administration 

Office of International Programs, New 

Delhi, India 

• Dr. Ken Earhart, Country Director, 

Centers for Disease Control and Prevention 

(CDC), U.S. Embassy, New Delhi, India 

• Dr. Jeremy Farrar, Director of the Oxford 

University Clinical Research Unit (OUCRU) 

in Ho Chi Minh City, Vietnam 

• Dr. Michael Favarov, Deputy Director 

General, Translational Research Division, 


Korea 

• Dr. Mark Feinberg, Vice President 

for Medical Affairs and Policy in Merck 

Vaccines and Infectious Diseases at Merck & 

Co., Inc. 

• Dr. N.K. Ganguly, Former Director 

General of Indian Council of General 

Research, New Delhi, India 

Acknowledgements 

Members of the task force would like to express gratitude to the many experts who generously shared their 

insights and opinions during the preparation of this report. We thank the following individuals who found the 

time to meet with us in various locations across the world, including: 

• Dr. Julie Gerberding, President, Vaccines, 

Merck & Co. Inc., West Point, PA, U.S.A. 

• Professor David Goldblatt, Professor of 

Vaccinology and Immunology and Head of 

the Immunobiology Unit, Institute of Child 

Health, University College London, U.K. 

• Professor Andy Hall, Chairman, UK 

Joint Committee on Vaccination and 

Immunisation, Professor of Epidemiology, 

London School of Hygiene and Tropical 

Medicine, London, U.K. 

• Dr. Pauline Harvey, Director, CDC 

Global AIDS Program, New Delhi, India 

• Mr. Seemant Jauhari, CEO at Apollo 

Hospitals Education & Research, Gurgaon, 

India 

• Dr. Ajay Khera, Deputy Commissioner, 

MCH Ministry of Health & Family Welfare, 

Government of India Ministry of Foreign 

Affairs and Trade, New Delhi, India 

• Mr. Kweon Ki-hwan, Director, Human 

Rights & Social Affairs Division, Ministry 

of Foreign Affairs and Trade, Republic of 

Korea, Seoul, South Korea 

• Dr. Danuta Krotoski, Acting Health 

Attache, US Embassy, New Delhi, India 

• Dr. Anjali Kulkarni, Consultant 

Neonatologist, Academic Coordinator 

Apollo Centre for Advanced Pediatrics, New 

Delhi, India 

• Dr. Altaf Lal, Chief Executive Officer 

of the Merck Wellcome Trust Hilleman 

Laboratories 

• Dr. Renu Lal, Influenza Coordinator, 

CDC, US Embassy, New Delhi, India 

Leveraging Public Private Partnerships to Address Global Vaccine Needs 2010-11

• Ms. Goan Yeoun Moon, Senior 

Administrative Manager, International 

Vaccine Institute, Seoul, South Korea 

• Dr. Shirshendo Mukherjee, Strategic 

Adviser, R&D Initiative, India Technology 

Transfer, Wellcome Trust, New Delhi, India 

• Mr. Kuldeep Negi, Assistant Manager, 

Corporate Communications at Panacea 

Biotech, New Delhi, India 

• Professor Sang-Dai Park, Professor 

Emeritus, Seoul National University, Seoul, 

South Korea 

• Dr. Vinod Paul, Chief of Pediatrics, All 

India Institute of Medical Science (AIIMS), 

New Delhi, India 

• Ms. Sujatha Rao, Secretary of Health 

and Family Welfare, Ministry of Health, 

Government of India, New Delhi, India 

• Dr. Bina Rawal, Head of Medical Affairs, 

Wellcome Trust, London, U.K. 

• Ms. Sonia Singh, Executive Assistant to 

the CEO, Hilleman Laboratories, New 

Delhi, India 

• Dr. Greg Smith, Production and Quality 

Control Coordinator, International Vaccine 

Institute, Seoul, South Korea 

• Professor Peter Smith, Professor of 

Tropical Epidemiology, London School of 

Hygiene and Tropical Medicine (Wellcome 

Trust Governor), London, U.K. 

• Dr. Jimmy Whitworth, Head of 

International Activities, Wellcome Trust, 

London, U.K. 

• Dr. Thomas Wierzba, Science 

Coordinator, International Vaccine Institute, 

Seoul, South Korea 

Finally, we would like to especially thank Dr. Julie 

Gerberding, President of Vaccines at Merck & Co., 

Inc. Through this task force, she and her team have 

introduced us to a fascinating and tremendously important 

project, for which we are truly grateful. 


Student Authors 

• Siddharth Chatterjee is a Master in 

Public Policy (MPP) candidate at Princeton 

focusing on international development and 

global health policy. Prior to coming to 

Princeton, Sid served the United Nations 

(UN) in Bosnia-Herzegovina, Iraq, Sudan, 

Indonesia, Kenya and Somalia. Sid worked 

with governments and local partners to 

ensure that children received immunizations 

and had access to clean water and sanitation, 

primary education, and protection. 

• Erica Frenkel is a second-year Master in 

Public Affairs (MPA) candidate at Princeton 

focusing on international development and 

pursuing a certificate in Health and Health 

Policy. Prior to coming to Princeton, Erica 

spent three years at the Kaiser Family 

Foundation working in media partnerships 

and trainings around global health 

(primarily HIV/AIDS) in Latin America, 

the Caribbean, and South Asia. 

• Gastón Gertner is a second-year 

MPA candidate at Princeton focusing 

on international development. Prior to 

beginning his Master’s at Princeton, Gastón 

worked as a Research Analyst for Ipsos, 

doing survey research consulting in public 

opinion, policy evaluation and market 

research in Argentina. 

About the Task Force 

• Hope Glassberg is a second-year MPA 

candidate at Princeton focusing on domestic 

politics and pursuing a certificate in Health 

and Health Policy. Prior to coming to 

Princeton, she worked at the Council of 

State Governments Justice Center, a non- 

profit working to improve collaboration 

between criminal justice and mental health 

agencies at the state level. 

• Amy Lin is a second-year MPA candidate 

at Princeton focusing on international 

relations. Prior to beginning her Master’s at 

the Woodrow Wilson School, Amy worked 

in Washington D.C. for the late Senator 

Edward M. Kennedy in his Labor Policy 

Office on the Senate Health, Education, 

Labor and Pensions Committee. 

• Talal Mir is a second-year MPA candidate 

at Princeton focusing on international 

development and health policy. Before 

coming to Princeton he worked in the U.S. 

Congress where, in the office of Senator 

John McCain, he managed a legislative 

portfolio that included health care policy. 

• Chloe Poynton is a second-year MPA 

candidate at Princeton focusing on 

international development. Before coming 

to Princeton, Chloe worked on issues of 

forced migration in Burundi, Sierra Leone 

and Kosovo. Most recently, she worked 

for UNDP in Sierra Leone as an Electoral 

Advisor. 


• Mark Roland is a second-year MPA 


international development and pursuing 

a certificate in Health and Health Policy. 

Prior to enrolling at the Woodrow Wilson 

School, Mark spent several years working 

for the Office of Medicaid in Massachusetts, 

helping to implement policies aimed at 

reducing health disparities. 

• Elie Teichman is a second-year MPA 


international development. Before coming to 

Princeton, Elie spent three years serving with 

the Peace Corps in Romania and before that 

worked in the office of former U.S. Senate 

Majority Leader Bill Frist, M.D. 

• Ben Tiede is an MPP candidate at 

Princeton. He enrolled at the Woodrow 

Wilson School after recently finishing 

a Ph.D. in Princeton’s Department of 

Molecular Biology. His Ph.D. research 

focused on studying adult stem cells and 

breast cancer, particularly on trying to 

understand the connection between breast 

cancer and pregnancy. 

Project Advisor 

• Adel A. F. Mahmoud, M.D., Ph.D, is a 

professor who is jointly appointed at the 

Woodrow Wilson School of Public and 

International Affairs and the Department of 

Molecular Biology at Princeton University. 

Previously, Professor Mahmoud served as 

president of Merck Vaccines from 1999 to 

2005. At Merck he was responsible for the 

company’s vaccine program that resulted 

in four new vaccines for rotavirus; HPV; 

shingles; and a combination vaccine for 

measles, mumps, rubella, and varicella. 

Mahmoud was Chairman of Medicine 

and Physician-in-Chief at Case Western 

Reserve University and University Hospitals 

of Cleveland (1987-1998), and Chief of 

Geographic Medicine (1977-1987). 


Executive Summary 

This report offers an evaluation of Merck-Wellcome Trust Hilleman Laboratories (Hilleman Laboratories or 

the labs), a public private venture launched in 2009 by the Wellcome Trust and Merck & Co., Inc. (Merck), 

intended to contribute to the development of high-impact, affordable vaccines for people in developing coun- 

tries. As a starting point, this report offers context on the global burden of infectious disease, borne dispropor- 

tionately by people living in the developing world, and discusses related challenges in developing, deploying, 

and financing vaccines to address this burden. This report reviews key findings from meetings with biomedi- 

cal and public health experts, stakeholders, and health practitioners about the Hilleman Laboratories and its 

potential role in the vaccine development process. Using this information, members of the task force crafted 

a set of recommendations, reviewed below, to guide the start-up and establishment of the labs. While these 

recommendations may reference scientific considerations, in light of the authors’ academic emphasis, the re- 

port is primarily focused on policy and practices. Finally, the report calls attention to challenges the Hilleman 

Laboratories’ leadership may face as the labs begin operations. 

Section Recommendations 

Hilleman Laboratories leadership should communicate the labs’ underlying goals 

to the public. 

Public Identity Hilleman Laboratories leadership should draw upon funders for legitimacy 

in certain settings, but stake out a unique position apart from project funders, 

particularly when working with local partners and NGOs. 

In the short term, the Hilleman Laboratories should focus primarily on projects 

that appear to have a high likelihood for success. 

In the longer term, the labs should broaden their project scope to mitigate risk 

and monitor down-market activities. 

Mission & Activities Hilleman Laboratories should establish and adhere to a rigorous systematic 

scientific audit to continually assess its project portfolio. 

Offer technical training to both low-cost manufacturers (LCMs) and government 

regulators to bolster capacities to ensure a safe vaccine manufacturing process 

and marketing success. 

Strengthen relationships with Indian government ministries and departments 

that oversee vaccine production and policies to secure the Hilleman Laboratories’ 

long-term position in India. 

Hilleman Laboratories should identify several LCMs or vaccine importers in 

Partnerships 

target countries to see projects through to completion in ways that meet quality 

standards. 

Identify local and international public health experts to collect relevant 

epidemiological data through field surveillance. 

Merck and the Wellcome Trust should consider further funding of the labs to 

ensure project completion and reduce distractions from core project development 

activities. 

Sustainability & Once products are developed, the labs should assess the potential of tiered 

Marketing 

pricing strategies so that markets in both lower and middle-income countries can 

access products. 

The Hilleman Laboratories should communicate with and work closely with 

government and non-government partners to foster demand for its products. 


List of Acronyms in this Report 

• AIIMS – All India Institute of Medical Science 

• CDC – Centers for Disease Control and Prevention 

• EPI – Expanded Programme on Immunization (as determined by WHO) 

• GAVI – GAVI Alliance 

• GBD – Global Burden of Disease 

• GOK – Government of Korea 

• IAVI – International AIDS Vaccine Initiative 

• IVI – International Vaccine Institute 

• LCM – Low-Cost Manufacturer 

• MOFAT – Ministry of Foreign Affairs and Trade (in the Korean Government) 

• MVP – Meningitis Vaccine Partnership 

• OUCRU – Oxford University Clinical Research Unit 

• PAHO – Pan-American Health Organization 

• PDP - Product Development Partnership 

• PDPPP - Product Development Public Private Partnership 

• R&D – Research and Development 

• SIIL – Serum Institute of India, Ltd. 

• SNU – Seoul National University 

• UN – United Nations 

• UNDP – United Nations Development Program 

• UNICEF – United Nations Children’s Fund 

• WHO – World Health Organization 


Table of Contents 

Introduction ................................................................................................................................................ 3 

About Hilleman Laboratories ..................................................................................................................... 5 

Key Findings from Meetings ...................................................................................................................... 6 

Background: Disease Burden & Challenges .............................................................................................. 8 

Analysis of Two Vaccine PDPs ................................................................................................................. 13 

An Alternate Approach: Decentralized Operations ................................................................................. 16 

Recommendations.................................................................................................................................... 18 

Ongoing Challenges ................................................................................................................................. 33 

Conclusion ................................................................................................................................................ 35 

Appendix 1: Timeline of Meetings ........................................................................................................... 36 

Appendix 2 ............................................................................................................................................... 37 

References ............................................................................................................................................... 39 


2 


Aims of the Report 

This report provides information on the existing gap 

in vaccine coverage between high- income countries, 

where vaccines are often first developed, marketed 

and consumed, and low-income countries, where 

the need for vaccines is typically greatest and seldom 

sufficiently addressed. Based on this background re- 

search, and on information gathered by the members 

of the task force through interviews with relevant ex- 

perts and practitioners in the field, this report out- 

lines the task force’s independent recommendations 

for the Hilleman Laboratories. These recommenda- 

tions advise the labs on topics relating to structure, 

including key partnerships to form, short- and long- 

term planning for projects, and relationships with 

governments and non-governmental entities to foster 

demand for its products. The task force does not of- 

fer scientific guidance on project selection in light of 

the policy focus of the report’s authors, however, for 

information on current vaccine development innova- 

tions and areas of further need and research, see Ap- 

pendix 2. The report also addresses the task force’s 

concerns about the laboratories’ mission and model 

for successfully and sustainably addressing the global 

vaccine gap. 

Introduction 

Methodology 

This task force was comprised of Masters students 

at the Woodrow Wilson School for Public and Inter- 

national Affairs at Princeton University and was led 

by Professor Adel Mahmoud, Professor in the Wood- 

row Wilson School and the Department of Molecu- 

lar Biology. Under Professor Mahmoud’s leadership, 

the students received instruction on the science un- 

derlying the global infectious disease burden, public 

health challenges facing low-income countries, and 

the policy landscape affecting vaccine production 

and manufacturing. The students visited and inter- 

viewed experts at the Wellcome Trust in London and 

at Merck in West Point, PA. Subsequently, the group 

divided to conduct further interviews with stakehold- 

ers, experts, and other relevant players in New Delhi, 

India, and to learn more about the public-private 

partnership model for vaccines by speaking with 

the leadership of the International Vaccine Institute 

(IVI) in Seoul, South Korea. 

In addition to leaders at IVI, task force members also 

interviewed experts and practitioners from the Indi- 

an Ministry of Health, private health care providers 

in India, a biotechnology company in India, health 

care practitioners, and Dr. Altaf Lal, the Chief Ex- 

ecutive Officer of Hilleman Laboratories. The task 

force also met with an academic and practicing ex- 

pert on vaccines, and toured the Gardasil plant at 

Leveraging Public Private Partnerships to Address Global Vaccine Needs 2010-11 

3

4 

Merck to view first-hand the vaccine manufacturing 

process. For a complete list and timeline of meetings, 

see Appendix 1. 

After synthesizing findings from academic literature 

on vaccines and the meetings described above, the 

task force crafted a core set of recommendations and 

associated action items for the labs, which are pre- 

sented in this report. 

Structure of the Report 

The report first presents key findings from the inter- 

views, which are divided into the following sections: 

public identity, mission & activities, partnerships and 

sustainability & marketing. Next, the report covers 

background information on the current landscape 

of the global burden of infectious disease, product 

development and delivery, safety and delivery chal- 

lenges, limitations, as well as an evaluation of two 

public-private partnerships focused on vaccine devel- 

opment. Finally, the report offers specific recommen- 

dations, categorized by the same topics as the find- 

ings above. Each recommendation includes specific 

action items to help the labs’ leaders meet overarch- 

ing goals. 


In September 2009, representatives from Merck, the 

Wellcome Trust, and the Hilleman Laboratories an- 

nounced their vision to establish the labs to develop 

vaccines that will address diseases prevalent in low- 

income countries. The partners plan to use the labs 

both to develop new vaccines and to optimize exist- 

ing vaccines for better delivery in developing country 

contexts. The Hilleman Laboratories represent the 

first time a research charity and a pharmaceutical 

company have partnered to form a separate joint 

venture with equally shared funding and decision- 

making rights. This venture will benefit from the 

ability to leverage Merck’s expertise in developing 

vaccines alongside the Wellcome Trust’s experience 

in high-quality, global biomedical research. Hille- 

man Laboratories will not engage in discovery re- 

search but will focus specifically on Phases I and II 

of product development and transfer work to other 

manufacturing partners to complete the product de- 

velopment process and ensure product affordability. 

In various situations, Merck will have preferred op- 

portunity to be a commercial partner once products 

are developed. 

About Hilleman Laboratories 

The labs will operate as a not-for-profit entity, with a 

strong emphasis on attaining a sustainable business 

model. Funding of the Hilleman Laboratories opera- 

tions will come from a combination of core funding 

from the founders, third-party grants, and other rev- 

enue flows. Merck and the Wellcome Trust’s initial 

total contribution will be 90 million British Pounds 

over seven years. Hilleman Laboratories leaders 

hope that, over time, the labs will receive revenue 

from products and that such revenue will be sufficient 

to sustain operations. Merck and the Wellcome Trust 

have agreed that any compensation received by the 

Hilleman Laboratories will be reinvested in support 

of its overall mission. 


5

6 

In Fall 2010, members of the task force conducted a 

variety of meetings in Princeton, London, New Del- 

hi, and Seoul to discuss the Hilleman Laboratories 

(see Appendix 1 for the list of meetings). Findings 

from these meetings were used to craft recommenda- 

tions in the following areas, highlighted in the previ- 

ous section: public identity, mission & activities, part- 

nerships, and sustainability & marketing. Findings by 

subject area are listed below. 

Public Identity 

• Experts noted the importance of bringing ac- 

ademic discoveries in biotechnology together 

with industry to foster translational research 

and believe that the labs may fill an impor- 

tant niche in this area. 

• Several individuals interviewed for this report 

in India, while very interested in the labs after 

learning of them, were not previously aware 

of the labs or indicated uncertainty about the 

intended scope of work, particularly beyond 

Phase II. 

Key Findings from Meetings 

• Some experts and practitioners raised a cer- 

tain level of scepticism regarding Merck’s in- 

volvement with a not-for-profit venture. 

Mission & Activities 

• The labs should most likely not undertake 

projects that address the “big three” diseases 

(HIV, malaria, tuberculosis) because of exist- 

ing resources and competition. 

• Over multiple meetings, there was a general 

consensus that heat stabilization vaccine tech- 

nology would be a valuable contribution in 

developing country contexts. This innovation 

could even be useful in countries with cold- 

chain capacity, as it could offer cost-savings 

on the delivery side. 

• Experts also expressed the need for novel, 

needleless delivery systems. 

Partnerships 

• Partnerships that bring together industry 

and academia can help refocus vaccine re- 

search on neglected diseases. Governments 

in intended markets as well as private sector 

entities must be integrated into the process 

to build capacity, facilitate emergence of a 

sustainable market, and reduce beneficiary 

countries’ dependence on philanthropy. 

• Collaborating with international organiza- 

tions, like the GAVI Alliance and WHO, 


among others, rather than competing with 

them, is important to establishing an interna- 

tional presence in vaccine development. 

• Having multiple low-cost manufacturers 

(LCMs) can insulate the vaccine supply from 

cross-national political tensions and ensure 

affordable market prices for vaccines in the 

developing world. 

• A good relationship with the Indian govern- 

ment can provide vital day-to-day opera- 

tional support and strengthen the long-term 

sustainability of the Hilleman Laboratories, 

for example, through favorable tax incentives 

or government subsidies. Close partnerships 

with government can help uncover potential 

problems, like the absence of a reliable cold- 

chain and lack of record-keeping capacity, at 

an early stage and allow parties to design ef- 

fective interventions. 

• Hilleman Laboratories leaders should con- 

sider partnering with local and international 

health experts in epidemiological surveillance 

to gain a more robust understanding of dis- 

ease prevalence. 

Sustainability & Marketing 

• Early in the process, the labs should iden- 

tify alternate funding sources other than the 

founding donors and be wary of relying too 

heavily on any one donor. 

• Given the high rate of growth of the middle 

class in India, it is estimated that the private 

market for vaccines over the few next years 

will be substantial. Similar scenarios are like- 

ly in other markets such as Brazil, Thailand, 

China and others. 

• Tiered or differential pricing for products – 

selling the same product at different prices 

in different countries or in different markets 

within the same country – is a way that the 

labs could derive revenue and still create 

products for the poorest market segments. 

• Practitioners discussed the difficulty of get- 

ting included into the recommendations of 

WHO Expanded Programme on Immuni- 

zation (EPI). The labs might find more suc- 

cess by pursuing projects that could be sold 

in both low- and middle-income countries to 

allow time for government and international 

organization procurement processes. 


7

8 

Background: Disease Burden & Challenges 

Global Burden of Disease 

The global burden of disease (GBD) is a measure of 

the morbidity and mortality caused by all the diseases 

of the world, injuries, and risk factors. While there 

are various measures of the GBD, all of which are 

somewhat imprecise (discussed further in the next 

section), by any account the developing world is dis- 

proportionately affected by infectious diseases. 

High-income Countries 1990 

2001 

Eurpoe and Central Asia 1990 

2001 

Latin America and Caribbean 1990 

2001 

Middle East and North Africa 1990 

2001 

East Asia and Pacific 1990 

2001 

South Asia 1990 

2001 

Sub-Saharan Africa 1990 

2001 

Fifty-six million people died in 2001 and about one- 

fifth of these deaths occurred in children under five 

years of age, almost all of whom lived in low and 

middle-income countries. 1 More than half of these 

child deaths were due to communicable diseases that 

could have been prevented by vaccination. 2 The fig- 

ure below 3 illustrates in detail how these diseases af- 

fect the developing world. 

Figure 1: Death rates by disease group and region in 1990 and 2001 for children aged 0-4 years 

Cause-specific death rates from 1990 estimated from Murray and Lopez might not be completely comparable to those for 2001 

jbecause of changes in data availablity and methods, plus some approximations in mapping in 1990 estimates to the 2001 regions 

East Asia and Pacific, South Asia, and Europe and Central Asia. For all geographical regions, high-income countries excluded and 

shown as single group at top of graph. The geographical regions therefore refer to low-and-middle-income countries only. 

0 5 10 15 20 25 30 35 40 45 

Death rate per 1000 children 

Malaria 

Diarrhoeal diseases 

Respiratory infections 

Other infectious and parasitic diseases 

Perinatal causes 

Nutritional deficiencies 

Non-communicable diseases 

Injuries 


Measurement 

As the figure above suggests, infectious diseases thrive 

where poverty and malnutrition are prevalent, sanita- 

tion and access to health services are poor, and vacci- 

nation rates for vaccine-preventable illnesses are low. 

These conditions are frequently prevalent in certain 

developing countries, including wide swaths of the 

African continent. 

Measuring the burden of infectious disease in devel- 

oping countries is critical for identifying appropriate 

and effective vaccines and other types of interven- 

tions, yet challenges to measurement are significant. 

In developing countries, epidemiological surveillance 

projects can be complicated by the difficulty in test- 

ing for a disease outside of an inpatient hospital set- 

ting, as well as by the availability of skilled health care 

workers or diagnostic tools. 4 Additionally, gathering 

data primarily from hospitals can skew findings, since 

conducting surveillance in hospitals may result in 

identifying only the sickest patients and overestimat- 

ing the burden of certain diseases. Alternatively, if 

patients tend to die before being tested, disease rates 

could be underreported. 

Infectious disease burden can also vary greatly within 

countries and regions, a nuance that is often not cap- 

tured in the literature. For example, in Africa there 

are important, often ignored, differences across and 

within countries that complicate the understanding 

of disease prevalence. 5 Ethnic or tribal movement 

across national borders contributes to cases in which 

outbreaks reappear regularly in areas with prior lo- 

cal extinction. 6,7 Further, seasonality can complicate 

measurement efforts; measles, for example, presents 

at different times of year and therefore, prevalence 

estimates could vary significantly depending on the 

timing of a study. For certain diseases such as chol- 

era, there is also pressure to underreport cases to 

minimize damage to international reputation and 

travel industries. 

In sum, disease burden indicators are often blunt 

measurements that can make understanding the nu- 

anced nature of disease burden difficult and compli- 

cate efforts to appropriately target interventions. 

Product Development & Access 

Although there may be uncertainty about the preva- 

lence of the diseases they are intended to address, 

immunizations are still widely regarded as among 

the most successful and cost-effective public health 

interventions. The last 30 years have seen tremen- 

dous successes in the development and reach of new 

vaccines, including the worldwide eradication of 

smallpox and the elimination of polio and measles in 

some parts of the world. In the last ten years alone, 

the vaccine market has nearly tripled in size. 8 


9

10 

Even so, serious problems persist with global access 

to vaccines, particularly within developing countries, 

due to lack of financing and substantial delivery chal- 

lenges. Though precise numbers are difficult to as- 

certain, there are an estimated 24 million children, 

mostly in developing countries, whom current vac- 

cination programs do not reach. 9 Considering the 

proven efficacy and life-saving abilities of many of 

these vaccines, and the mortality rates of children in 

developing countries as a result of diseases with exist- 

ing vaccines, this gap in coverage has serious conse- 

quences. 

Financing Challenges 

The high cost of research and development, coupled 

with the small number of vaccine-producing firms, 10 

drive the prices of vaccines up to prohibitively ex- 

pensive levels. Markets in developing countries that 

critically need these vaccines simply cannot afford 

them. These high prices mean that aid and programs 

are needed to help low-income countries access vac- 

cines. According to UNICEF, an additional one bil- 

lion dollars per year is needed to provide vaccines to 

children in the 72 poorest countries. 11 The GAVI Al- 

liance, launched in 2000 to expand the scope and ac- 

celerate the delivery of newer vaccines to children in 

the poorest countries, is already experiencing fund- 

ing shortfalls 12 and the prospect of making additional 

large-scale purchases of vaccines in the near future is 

bleak. Although differential pricing could be used to 

make vaccines more affordable for developing coun- 

tries, at this time there is some reluctance among U.S. 

manufacturers due to political considerations. 13 

Another issue to be addressed is the relatively small 

number of donors to global vaccine programs. A re- 

cent study on the expenditure patterns of Product 

Development Partnerships (PDPs) found that 77.1 

percent of existing PDPs’ budgets are provided by 

five funders, with the Gates Foundation contributing 

nearly half of all funding. 14 Development agencies 

of industrialized countries round out the rest of the 

top five funders, each providing over $20 million to 

such efforts in 2007. Given global economic uncer- 

tainty, tight public budgets and failing returns on en- 

dowments, heavy reliance on a few funding sources 

should be an area of global concern. Furthermore, 

the Gates Foundation’s generous funding of orga- 

nizations in the U.K. and the U.S. may accentuate 

existing geographical resource asymmetries between 

developed and developing countries. 15 

Delivery Challenges 

In addition to access and financing challenges, care- 

ful consideration should be given to how vaccines 


that do reach the developing world are delivered in 

real-world (and often sub-optimal) conditions. Such 

safety concerns extend well beyond the clinical trials 

that take place before a product is introduced to the 

market. 

Accidental sharps exposure 

Without proper precautionary measures, the 

vaccination process can be particularly risky for 

health care professionals and patients. Needle- 

sticks and sharps exposures can expose both pa- 

tients and healthcare workers to transmission of 

a variety of serious diseases. Empirical research 

from the developing world reveals a pressing 

need to improve knowledge among nurses and to 

promote practices that reduce the risk of needle- 

based injuries to stem the spread of infectious dis- 

eases. Stronger training programs, provision of 

low-cost technologies (e.g., puncture-proof con- 

tainers), institutionalized systems for addressing 

sharps injuries in health centers, and improved 

preventative vaccination of health care workers 

and hospital staff are all associated with a re- 

duced risk of disease transmission, particularly in 

developing countries. 16,17 

Developing needleless delivery technologies 

would represent a major advance that could al- 

leviate the need for many of these training pro- 

grams. 

Disposal and disinfection of biowaste 

Improper disposal of vaccination-related bio- 

waste (e.g. used syringes) can also lead to unnec- 

essary exposure of otherwise healthy individuals 

to dangerous infections. Without proper materi- 

als, training and procedures in place, the vaccina- 

tion process can spread rather than staunch the 

transmission of disease by introducing pathogens 

through the water, air, soil, and direct human-to- 

human contact. 

Cold-chain limitations 

Parts of the developing world lack comprehensive 

refrigeration systems; sustained periods without 

refrigeration can compromise the efficacy and 

safety of vaccine products. Furthermore, there is 

evidence that weaknesses in the cold-chain lead 

to waste or delivery of unsafe vaccines. Research 

in South Africa revealed that polio outbreaks 

were likely a consequence of a compromised 

cold-chain, while a study in Hungary showed that 

fluctuations in temperature were rendering vac- 

cines useless. 18 There are also studies in India that 

illustrate how weaknesses in the cold-chain for 

oral polio vaccine in rural districts put children at 

risk. 19 In light of these findings, establishing heat- 

stable vaccines may be a critical innovation that 

revolutionizes the health community’s ability to 

bring vaccines to once unreachable populations. 


11

12 

Post-marketing surveillance. 

Even the largest of Phase III trials are insuffi- 

cient in determining all of the possible risks in- 

herent in vaccine delivery. The relative rarity of 

serious side effects, limited numbers of human 

test subjects, and other design limitations make 

post-market monitoring crucial to ensuring vac- 

cine safety. The challenge with an after-market 

surveillance system is that it is inherently pas- 

sive: reports of adverse effects are voluntarily 

submitted both by health providers and the pa- 

tients themselves. These submissions are helpful, 

but tend to be inconsistent and underreported. 20 

Equally as important, reporting rates of adverse 

effects should not be confused with incidence 

rates or with causality. Even “passive” data col- 

lection systems have provided valuable insight 

into troubling trends caused by vaccine delivery 

that would otherwise have been missed. Studies 

have used passive data to debunk the relationship 

between diphtheria vaccine and sudden infant 

death syndrome 21 , and in other cases allowed re- 

searchers to compare rates of adverse reactions 

and make modifications to immunization recom- 

mendations. 22 


The previous section outlined the myriad difficulties 

in developing, delivering, and financing vaccines for 

the developing world. Though challenges are sub- 

stantial, in recent years, several entities have sought 

to provide an infusion of resources via product devel- 

opment partnerships (PDPs) to jump-start efforts to 

meet these challenges. 23 The Hilleman Laboratories 

joins a small but notable group of PDPs focused spe- 

cifically on vaccine development. This section briefly 

reviews key components of, and operational hurdles 

associated with, two such efforts: the Meningitis Vac- 

cine Partnership and the International Vaccine In- 

stitute. 

Analysis of Two Vaccine PDPs 

Meningitis Vaccine Partnership 

In 2001 the Meningitis Vaccine Partnership (MVP) 

was initiated as a collaboration between the WHO 

and PATH, an international global health non-prof- 

it. 24 While the effort does not have one major indus- 

try partner like Merck, it has collaborated closely 

with private entities such as the Serum Institute of 

India Ltd (SIIL). From the start, the MVP, unlike 

other PDPPPs, fulfilled a coordinator role to bring to- 

gether financial resources, intellectual property, and 

in-country distribution expertise, instead of fulfilling 

a pure product development role (e.g. starting a proj- 

ect from the very beginning). Since components of 

the Meningococcal A vaccine already existed, it was 

the conjugation technology that was needed to craft 

a vaccine that would best target the serotype most 

prevalent in Africa. 

Key components of the strategy: 

Due diligence prior to product development 

activities 

The MVP emerged following a WHO-led 

assessment of meningitis burden in Africa. 25 

This focused research sweep ensured that pri- 

or to beginning development, MVP leaders 

had a sense of existing intellectual property, 

clinical research, and a highly focused mis- 

sion, further shaped by joint resolutions that 

came out of the assessment. 26 

Partnerships with “emerging suppliers” 

MVP worked closely with Indian manufac- 

turer, the Serum Institute of India Limited 

(SIIL) in Pune, India, to supply tetanus tox- 

oid and to manufacture the Meningococcal 

A conjugate vaccine. 27 Specifically, SIIL, with 

the transferred conjugation technology in 

hand, developed test batches, oversaw animal 

testing, and completed Phase I testing. SIIL 

was also connected to distribution efforts by 

producing 25 million doses of the vaccine an- 

nually. 28 


13

14 

Clear price parameters 

The PATH-SIIL agreement set out an ini- 

tial pricing of US$0.40 per dose for sales of 

the vaccine to countries within the African 

meningitis belt; this pricing will eventually in- 

crease to US$.50 per dose. Though this pric- 

ing ensured that final products were afford- 

able in developing countries, interviews with 

various sources conducted by the task force 

indicated that the price structure was too rig- 

id and too low. 

International Vaccine Institute 

The International Vaccine Institute (IVI) grew out 

of the United Nations Development Programme’s 

(UNDP) Child Vaccine Initiative in 1993 as a result 

of an agreement within the international community 

about the need for a public sector research organi- 

zation focused exclusively on the development of 

vaccines for people in developing countries. Twelve 

countries and the WHO signed the founding docu- 

ment (this number has since grown to 40). After an 

independent selection committee chose the Republic 

of Korea as host of the institute, the Korean gov- 

ernment (GOK) donated IVI’s building on Seoul 

National University’s (SNU) campus and funded the 

equipping of the laboratories. 29 The GOK’s goal in 

welcoming a UN-sponsored international organiza- 

tion during the country’s period of immense growth 

was to attract more international institutions to 

Seoul, both to allow the country to give back to the 

world for the support it received during its time as a 

UN-recipient country and to establish a reputation 

for scientific innovation. 30 

The Institute was founded with a clear mission: “To 

combat infectious diseases through innovations in 

vaccine design, development and introduction, ad- 

dressing the needs of people in developing coun- 

tries.” 31 To pursue this mission, IVI works in every 

stage of vaccine development from “bench to com- 

munity,” a continuum comprised of: 1) design of new 

routes for delivery of vaccines; 2) improvement of 

vaccine manufacturing processes, technology trans- 

fer, and regulatory support; 3) clinical assessments 

of vaccine candidates; 4) collection of evidence to 

support the introduction of under-utilized vaccines 

in developing countries; 5) data synthesis, analysis, 

and dissemination to promote vaccine availability; 

and 6) building capacity among vaccine profession- 

als in developing countries. 32 To achieve these goals 

IVI has its headquarters in Seoul, field presence in 29 

countries in Asia, Africa, and Latin America, 33 and, 

since 2008, offices of Policy & Economic Research 

and Communications & Development to help raise 

awareness among donors and developing country 


governments of the importance of the organization’s 

work and policies to support vaccination efforts. 

Challenges: 

Attracting senior talent 

The size of the IVI staff working in each of 

these stages has grown considerably from 

a staff of 74 in 2003 to 152 in 2009, with 

projections of 190 in 2012, representing 18 

countries. However, while roughly 50 percent 

of its staff is not Korean, 34 the organization 

has had trouble attracting top international 

talent to come and live in Seoul. Through its 

relationship with SNU, the organization has 

been able to work with Korean Ph.D. candi- 

dates and attract Korean faculty as advisors. 

Nevertheless, IVI’s location in Seoul remains 

a challenge to top-tier recruitment. 

Location 

While the Korean government has been a fi- 

nancial and political asset to IVI by donating 

the land and equipping the facilities among 

other contributions, the location in Korea of 

an organization focused on developing coun- 

try diseases is a challenge, given that the bulk 

of the burden of many diseases is in Africa 

and South Asia. 35 As IVI seeks to broaden 

its reach into Africa and Latin America, this 

challenge may become more acute. 

Funding 

IVI’s funding challenges are two-fold. First, 

as a purely international, non-profit institu- 

tion, the organization’s budget comes exclu- 

sively from governmental, non-profit, and 

private-sector donors. While this budget grew 

from $11 million in 2003 to $26 million in 

2009, 36 the vast majority (80 percent) is ear- 

marked for specific projects, leaving very little 

flexible money to fund the day-to-day opera- 

tions of the organization. 37 Second, the orga- 

nization’s funding is relatively uneven among 

donors and organizational distribution, with 

a disproportionate amount coming from the 

Gates Foundation. Out of an estimated 2007 

budget of $25.5 million, Gates gave $17 mil- 

lion. The next biggest donor, the GOK, gave 

$4.5 million. 38 As referenced in the financing 

challenges section, this reliance on one large 

donor has the potential both to dictate re- 

search efforts and to leave the organization 

vulnerable to the whims of funders’ interests. 


15

16 

The Hilleman Laboratories has the advantage of 

learning from the successes and mistakes of other 

PDPs. One significant challenge the labs leadership 

face, presumably like other PDPs, is how to structure 

operations. Working within a single country could 

lead to perceptions that the labs is intended to solely 

address the Indian market, when in fact leaders hope 

to position the labs as a global presence. In addition, 

there are many logistical and regulatory hurdles as- 

sociated with operating in the Indian context (see the 

Challenges section for additional details). To address 

these concerns, one suggestion is a decentralized 

operation. This could mean that the labs operate in 

multiple countries and/or that the labs exist more 

virtually rather than as a bricks and mortar initiative 

in one location. These multiple outfits could serve 

to connect existing research efforts, academics, and 

global health practitioners. 

This report carefully considers the earlier conception 

of the labs as a physical venture headquartered in 

India, however the task force wished to provide early 

feedback about the idea of decentralized operations, 

whether in lieu of or supplemental to physical labs 

in India. 

An Alternate Approach: 

Decentralized Operations 

Framing questions: 

To decide whether or not to pursue decentralized op- 

erations and a slightly reframed mission, as described 

above, Merck, Wellcome, and Hilleman Laboratories 

leaders must consider several key questions: 

• What exact role would the labs play if decen- 

tralized: would it provide funding to clinical 

researchers and then transfer these discover- 

ies to low-cost manufacturers (LCMs) capable 

of conducting Phase I/II research? 

• Will Merck still potentially make pre-clini- 

cal discoveries available to decentralized lab 

partners, as proposed with the physical labs? 

• What regulations and limitations would the 

labs be subject to (with key contributors in 

different locations and countries, performing 

various operations), and how do these help 

inform and dictate the optimal structure of 

the decentralized labs? 

• Will the labs’ locations accept submissions of 

research from individuals looking for partners 

beyond the initial stages? 

• If so, does Merck have any right to follow up/ 

pick up the research from among the submis- 

sions, along the lines of the preferred com- 


mercial partner status it enjoys through the 

labs as currently configured? What message 

is communicated if Merck passes on an op- 

portunity? 

Benefits of a decentralized set-up: 

• Signals that the intent of the labs is to develop 

low-cost vaccines for the developing world at- 

large, not just for India. 

• Avoids some of the regulatory hurdles associ- 

ated with setting up a brick and mortar entity 

in India (see Challenges section for further 

discussion). 

• Enables Merck and the Wellcome Trust to 

foster partnerships with clinical innovators 

as well as low-cost manufacturers across the 

globe. 

• Creates an independent image for the labs 

(distinct from Merck) by connecting the labs 

to multiple partners; other corporations might 

be more likely to partner with the labs if the 

research seems less closely tied to Merck. 

• Mitigates risk by including a more diversified 

project portfolio and, if pursued in conjunc- 

tion with a physical lab, offers a readily acces- 

sible network of partners to test any products 

developed. 

• Enables Merck to conduct translational re- 

search, possibly more efficient than if per- 

formed in a nascent labs setting, and then 

transferring products to the network. 

Drawbacks of a decentralized set-up: 

• Challenging to define the identity and spe- 

cific value-added of the labs with different lo- 

cations/partners and approaches to diseases. 

This includes the difficult task of addressing 

Merck’s involvement, and the fact that poten- 

tial partners could be hesitant to join for fear 

of pressure from such an entity. 

• Undermines the opportunity to make inroads 

into the Indian market afforded by having a 

physical presence in India; similarly, it is dif- 

ficult to assess whether a virtual arrangement 

would be taken as seriously as an organiza- 

tion with physical location. 

• Places an added administrative burden on 

the Hilleman Laboratories to understand a 

broader array of regulatory environments 

where partners are based. 


17

18 

1. Public Identity 

It is critical for the Hilleman Laboratories’ leaders to 

establish a clear “niche” within the existing sphere of 

vaccine development initiatives. This public engage- 

ment is especially important for ensuring ongoing 

funding (discussed further in a subsequent section). 

While the labs’ leaders have already taken important 

first steps to clarify its role, including a 2009 press 

release indicating that it will seek to move clinical dis- 

coveries to “proof of concept,” and optimize existing 

products for developing country contexts, 39 we sug- 

gest that the Hilleman Laboratories’ leadership take 

further actions to outline the initiative’s aims. 

Members of the task force understand the challenge 

of managing public relations concurrent to launch. 

However, by not advancing a clear message broadly 

and early on, the labs run the risk of misinforma- 

tion spreading or undermining efforts to generate 

publicity at a later stage. To avoid those scenarios, 

we suggest that the labs proactively foster public en- 

gagement. In so doing, leaders will be better able to 

recruit and retain talent, maintain relationships with 

government officials, and ultimately sell products. 

To be sure, the labs must walk a difficult public rela- 

tions line. Though maybe unjustified in some con- 

texts, it is nonetheless true that non-governmental 

organizations, stakeholders, and some individuals 

Recommendations 

view pharmaceutical companies’ actions in the de- 

veloping world with heightened suspicion. 40 In some 

cases, these stakeholders may be wary of motives for 

a pharmaceutical company’s charitable initiatives. In 

a different vein, stakeholders may be unsure of the 

Wellcome Trust’s intentions in investing in the labs, 

particularly given the Trust’s other activities in India 

focused on translational research. Hilleman Labora- 

tories leadership should be aware of these percep- 

tions and respond accordingly. The recommenda- 

tions in this section are intended to offer guidance 

about the best ways for labs executives to craft a pub- 

lic identity: 

RECOMMENDATION 1.1: Hilleman Labo- 

ratories leadership should communicate the labs’ 

underlying goals to the public. 

Action 1.1.1: Advance clear goals 

On the Hilleman Laboratories website, there 

is information available about the operating 

model and answers to frequently asked ques- 

tions. These materials reflect the broad scope 

of what the labs intend address. Part of de- 

fining the labs’ goals should be stating clearly 

that the labs are being created to help the en- 

tire developing world so that expectations are 

not created for it to be an India-focused enti- 

ty. We believe that the labs would also benefit 


from outlining overarching operational goals 

that drive actions or the key reasons under- 

pinning the need for an endeavour focused 

specifically on translational research (Phase 

I and Phase II activities) and how such ac- 

tivities will align with existing efforts. In short, 

the task force believes that more work is need- 

ed to communicate the mission and guiding 

principles driving the Hilleman Laboratories. 

Action 1.1.2: Clarify the role of the labs beyond 

Phase II activities 

Hilleman Laboratories leadership have in- 

dicated a desire to focus on activities around 

Phase I and II of vaccine development. 

While recognizing that resources are limited 

and that it is important not to take on too 

much too early, the task force also contends 

that the labs should take steps to establish and 

clarify, publicly, their role beyond Phase I and 

II. Even if the labs are not going to conduct 

Phase III trials or directly market products to 

countries, we suggest that it is still in the labs’ 

leadership’s best interests to (1) have a clear 

mission beyond taking products to the proof 

of concept phase (discussed further in the 

Mission & Activities section), (2) determine 

how they intend to meet this mission, and 

(3) take steps to communicate this mission to 

the public. For example, the leadership could 

highlight publicly via press releases, websites, 

or joint events their collaboration with inter- 

national organizations and government enti- 


ties 

Taking such actions will amount to more than 

just good public relations. Potential hires will 

have a better sense of the labs’ mission (and 

what is beyond their core mission), as well as 

other entities operating in different aspects 

of the vaccine product development process, 

like low-cost manufacturers who will be less 

apt to view the labs as a competitor and more 

as a potential partner. 


ratories leadership should draw upon funders 

for legitimacy in certain settings, but stake out a 

unique position apart from project funders, par- 

ticularly when working with local partners and 

non-governmental organizations (NGOs). 

Action 1.2.1: Make clear to the public how the 

initiative intends to retain independence 

Though the labs will certainly draw upon ex- 

pertise from Merck and the Wellcome Trust, 

it is also important for the public, stakehold- 

ers, and potential project partners to view the 

initiative as an entity unto itself, not simply 

19

20 

an arm of either of the funders. To that end, 

Hilleman Laboratories leadership should es- 

tablish processes for maintaining some meas- 

ure of independence and communicate these 

strategies. To achieve this goal, the labs may 

wish to appoint an independent advisory 

board without Merck/Wellcome represen- 

tation and/or create other communication 

channels with non-funder partners via regu- 

lar meetings or conferences. Members of the 

board would represent academia, interna- 

tional organizations and first line representa- 

tives from global health policy circles. Further, 

few public-private global health partnerships 

have representatives from low- and middle- 

income countries on their boards. 41 By bring- 

ing these stakeholders to the table, Hilleman 

Laboratories could potentially increase legiti- 

macy in the eyes of future customers while 

simultaneously strengthening public orienta- 

tion and commitment to targeting vaccina- 

tion gaps in the developing world. 

Action 1.2.2: Use the Merck/Wellcome brand to 

maximize impact in certain settings 

Merck and Wellcome have invested signifi- 

cant resources in the labs and leaders should 

take care to publicize in certain settings the 

incredible breadth of experience that both 

partners bring to the table. In fact, CEO Dr. 

Altaf Lal has articulated that he envisions 

that the labs will bring a private sector strat- 

egy to achieve public goods. 42 When connect- 

ing with staff from other industry organiza- 

tions, for example, it is logical for the labs to 

actively highlight Merck’s role and the influ- 

ence of private sector on the labs’ operations. 

For recruitment efforts, the labs’ leaders may 

wish to make this affiliation clear to signal the 

prestige, planning, and stability associated 

with industry buy-in. Likewise, the partner- 

ship with the Wellcome Trust can be use- 

ful in talking with global health community 

partners in India and beyond; the Wellcome 

Trust already has a substantial presence in In- 

dia via a partnership with the Department of 

Biotechnology 43 and an R&D initiative. 44 

2. Mission & Key Activities 

Vaccine development is a risky and expensive busi- 

ness. Even low-end projections estimate the cost of 

developing new vaccines to be $200 to $500 million. 

There are approximately 5:1 odds against a pre-clin- 

ical vaccine reaching the market. 45 Because of this 

risk, many PDPPPs have sought to diversify their 

project portfolios. 


Taking on too much risk too early, however, can 

jeopardize long-term stability if none of the risks 

pan out. Conversely, focusing too narrowly on just 

low-risk projects could expose the labs to competi- 

tion from many other players also seeking the same, 

more approachable targets. Generally speaking, the 

labs should focus on “low hanging fruit” in the short- 

term to help build a reputation for success in the field, 

while undertaking more high-risk projects over time. 

Importantly, to achieve maximal stability, the labs 

will need to seek out partnerships to select projects 

and ensure developed products are manufactured 

and delivered in a safe, efficient manner. With the un- 

derstanding that the labs’ mission and key activities 

should evolve over time, the task force recommends 

a variety of short and long-term goals that will en- 

able the labs to eventually achieve a diverse project 

portfolio. 

RECOMMENDATION 2.1: In the short 

term, the Hilleman Laboratories should focus 

primarily on projects that have a high likelihood 

for success. 

Action 2.1.1: Choose roughly three initial projects 

to take on, at least one of which should focus 

on optimization of an existing vaccine for the 

developing world 

The task force recommends that the labs take 

on a small portfolio of initial projects intend- 

ed to optimize existing products rather than 

develop wholly novel vaccines. Optimization 

could entail focusing on heat-stable products 

in order to address limited cold-chain capac- 

ity in developing country contexts, or safer 

delivery mechanisms (e.g. non-needle-based 

products) that would reduce challenges in 

both delivering and disposing of vaccines. 

(See Appendix 2 for recent vaccine innova- 

tions). 

Specifically, a heat stable rotavirus vaccine 

represents a logical initial target; the labs 

can leverage RotaTeq expertise from its close 

working relationship with Merck. Further, the 

recent generation of a heat stable recombi- 

nant hepatitis B vaccine 46 suggests that this 

goal is technically feasible. Other initial pro- 

jects may address safety issues. While from 

a risk-perspective, taking on more projects 

increases the likelihood of success, the task 

force still recommends that the labs take on 

a fairly modest project portfolio in the early 

years. By staying focused, the labs reduce the 

risk of losing sight of project priorities. Fur- 

thermore, if the labs are able to establish a 

reputation for the capacity to optimize exist- 

ing vaccines, this could help to foster partner- 

ships with other companies that want to opti- 

mize their vaccines. 


21

22 

In the medium- to long-term, the labs may 

want to take on at least one project focused 

on production of a vaccine from a novel strat- 

egy for risk-mitigation and research purposes. 

It is worth noting, however, that no PDPPPs 

have ushered a totally new vaccine from pre- 

clinical discovery to market as of yet. PDPPP 

successes to date, namely the MVP initiative’s 

meningitis vaccine, 47 and the IVI’s cholera 

vaccine have focused on refining existing 

products for the developing world. However, 

it would be fruitful for the labs to build capac- 

ity for production of novel vaccines to avoid 

specializing too much on optimization. 

Action 2.1.2: Monitor the changing landscape of 

private industry vaccine research to determine 

which targets should be selected or avoided, 

including but not limited to the “big three” 

diseases (HIV, malaria, tuberculosis) 

Given the relatively limited resources of the 

labs compared to major pharmaceutical 

companies, leaders should avoid pursuing 

projects with later-stage competitor products 

from major firms. Other PDPPP efforts are 

instructive on this point: some have specu- 

lated that IVI may encounter challenges in 

developing its typhoid vaccine and achiev- 

ing a significant market share given industry 

competition. The scope of products that fall 

in this category is likely to change given that 

certain diseases formerly of interest in devel- 

oping country settings only, now have emerg- 

ing developed country markets due to changing 

ecological conditions (e.g., dengue fever) and 

tourism-based interest. 

Even though as a general precept the labs 

should avoid direct industry competition 

where possible, one exception would involve 

projects like heat-stable RotaTeq, where the 

labs may be able to produce cheaper prod- 

ucts better tailored for delivery in developing 

country settings, where cold-chains and other 

infrastructure are in short supply. This, of 

course would necessitate proper evaluation 

of intellectual property issues and royalty im- 

plications that could undercut the labs’ bot- 

tom line. 

Finally, we suggest that the Hilleman Labo- 

ratories avoid projects related to the “big 

three” diseases since a great deal of money 48 

and time has already been directed to other 

initiatives focused on these diseases, without 

notable success. 

RECOMMENDATION 2.2: In the longer 

term, the labs leadership should broaden its proj- 

ect scope to mitigate risk and monitor down-mar- 

ket activities. 


Action Item 2.2.1: Expand the institutional focus 

beyond Phases I and II to ensure the quality of 

product development and monitor how external 

developments affect project scope and launch 

Though the labs’ core activities will initially 

focus on Phases I and II, the task force strong- 

ly recommends that the Hilleman Laborato- 

ries define its plans for engaging in efforts be- 

yond Phase II. While the labs will not conduct 

Phase III trials or get into direct marketing 

efforts, it is important from a “brand name” 

perspective to ensure that there is satisfac- 

tory product demand and that the products 

ultimately sold by low-cost manufacturers are 

of a quality commensurate with Merck’s, the 

Wellcome Trust’s, and the Hilleman Labora- 

tories’ reputations. 

There is of course, the danger of mission 

creep in entering into too many downmarket 

activities. Even MVP has conceded problems 

in getting too involved in marketing and dis- 

tribution, noting scenarios where countries 

were fully mobilized to distribute the ini- 

tiative’s vaccine when the product was not 

ready. 49 In other words, the labs’ leadership 

should be hesitant to engage in too much 

marketing activity before products are ready 

to sell. However, having a process ready for 

overseeing down-market activities well in ad- 

vance of sales will safeguard the labs’ reputa- 

tion and increase the likelihood of marketing 

success. 

Specifically, we suggest that the labs hire a 

market liaison to focus on public awareness, 

advocacy and market assessment. 50 Such a 

position could partner with LCMs during 

Phase III trials or when products are formal- 

ly brought to market. Also, to more broadly 

monitor the environment into which the labs 

products will be released, we suggest that the 

labs establish an Office of Communications 

and Public Affairs (OCPA), discussed in more 

detail later in this report. Staff within this of- 

fice should be responsible for interacting with 

Indian government officials and other key 

stakeholders in India. This type of work en- 

sures that the labs’ leadership are kept abreast 

of any policy, legal, or technological changes 

that influence their projects. The Partner- 

ships section describes specific actions this of- 

fice could take to support the labs. 


ratories should establish and adhere to a rigorous 

systematic scientific audit to continually assess its 

project portfolio. 

Examples such as the RV144 HIV vaccine trial 


23

24 

have shown a reluctance of corporations to cut 

ties with seemingly ineffective vaccine candi- 

dates. 51,52 To prevent a similar scenario, every 1-2 

years the Hilleman Labs should be diligent about 

having a review to measure progress (performed 

by an independent, external group within the 

vaccine development community). Given that 

the labs will be a non-profit organization, strictly 

adhering to this requirement will be important, 

rather than just initially committing to it without 

follow-through. Merck and the Wellcome Trust 

may want to establish contingencies whereby 

continued funding is dependent on the successful 

administration of these meetings. Making such 

reviews meaningful will require a firm endorse- 

ment from the labs’ leadership, communicated 

from the initial launch. These assessments will 

provide a useful, recurring incentive for scientists 

to produce tangible results by stated deadlines. 

RECOMMENDATION 2.4: The Hilleman 

Laboratories should offer technical training to 

both low-cost manufacturers (LCMs) and gov- 

ernment regulators to bolster capacities to ensure 

a safe vaccine manufacturing process and mar- 

keting success. 

Action 2.4.1: Hilleman Laboratories leadership 

should be prepared to assess whether a lowcost 

manufacturing partner has the necessary 

capacity to safely manufacturer vaccines 

While the labs may not produce or distribute 

the vaccine, the labs will be irreversibly asso- 

ciated with any product mishaps that occur 

as a result of negligence in the production 

chain. To preserve the Hilleman Laborato- 

ries reputation and integrity, the labs’ lead- 

ership must thoroughly assess the capacities 

of its manufacturing partners and identify a 

methodology for improving weaknesses in its 

partners. 

Action 2.4.2: Create a department responsible 

for training and capacity building focused on 

working with both government officials and lowcost 

manufacturers in India 

The long-term safety and efficacy of the 

Hilleman Laboratories’ products depends 

on the ability of governments to effectively 

regulate manufacturers and administrators 

of vaccination programs for safety. It will be 

necessary to have varying degrees of capac- 

ity building in the design and scaling-up of 

the vaccine production and delivery process. 

Hilleman Laboratories-designed and imple- 

mented training modules can likely help fill 

this gap in capacity as well as protect against 

potential accidents. As previously discussed, 

a staff position or department tasked with 

overseeing market strategies could fulfil these 

goals. As a part of this effort, this office could 


also be responsible for exploring opportuni- 

ties for small-scale data collection, potentially 

via LCM partners, to evaluate product safety 

in the after-market. 

3. Partnerships 

Effective collaboration with both host-country and 

global stakeholders is essential for the Hilleman 

Laboratories’ long-term stability. Meaningful part- 

nerships can enable the labs’ leadership to identify 

both potential roadblocks as well as opportunities for 

innovation. Building trusting relationships can also 

improve the labs’ reputation, knowledge base and ca- 

pacity in identifying and developing vaccines that ad- 

dress a true global health need for poor populations. 

Further, one of the comparative advantages of plac- 

ing the Hilleman Laboratories in a less-developed 

country is its proximity to the challenges posed by 

infectious diseases. The labs’ leadership should seize 

upon the opportunity to work with on-the-ground 

governmental, non-governmental and for-profit or- 

ganizations to better understand what these stake- 

holder groups perceive to be the priorities and ob- 

stacles to effectively combating disease in developing 

contexts. This local expertise can provide the labs’ 

leadership with valuable feedback about its priorities 

and a host of potential partners for product design, 

vaccine production, and delivery. This section high- 

lights a range of potential organizations and entities 

that the labs’ leadership should consider as potential 

partners. 

RECOMMENDATION 3.1: Strengthen re- 

lationships with Indian government ministries 

and departments that oversee vaccine production 

and policies to secure the Hilleman Laboratories’ 

long-term position in India. 

Action 3.1.1 Establish an Office of 

Communications and Public Affairs (OCPA) tasked 

with outreach to the Government of India 

Government relationships are vital to under- 

standing and complying with the regulatory 

framework in which the Hilleman Labora- 

tories will operate. For example, in its early 

stages, the Hilleman Laboratories may have 

to rely on foreign nationals to fill senior re- 

search positions. The OCPA could focus its 

early efforts on attaining an expedited visa 

agreement for hiring foreign nationals and 

any other potential administrative roadblocks 

to bringing foreign nationals into the country. 

The OCPA could also push for a similar tax- 

advantaged status that the Hilleman Labo- 

ratories’ peers were accorded in order to be 

competitive within India and internation- 


25

26 

ally. 53 The emphasis on building strong re- 

lationships between the labs and the Indian 

government reflects the Wellcome Trust’s 

previous experience working with the De- 

partment of Biotechnology and the role that 

a positive working relationship can have in 

expediting project progress. 54 

Action 3.1.2 Identify and support public sector 

initiatives at higher education institutions that 

complement the work of Hilleman Laboratories 

Laboratory and research assistant positions 

are junior-level positions that would ideally be 

filled by Indian nationals rather than recruit- 

ing and relocating more expensive foreign 

nationals. The labs’ leadership should pursue 

a policy of partnering with national labora- 

tories or colleges and universities to expand 

the number and quality of technically trained 

graduates that can fill laboratory positions at 

the labs. These partnerships might include 

establishing an internship or externship pro- 

gram through a higher education institution 

or sponsoring campus recruitment activities. 

The Wellcome Trust can offer vital expertise 

in this area, since it has already made inroads 

into Indian universities through partnering 

with the Government of India’s Department 

of Biotechnology. 

Connections to academia can provide the 

labs with a more dispassionate local perspec- 

tive on vaccine needs and challenges, as well 

as a sense of the true capacities of local gov- 

ernments and NGOs to deliver and monitor 

services. The Wellcome Trust’s pre-existing 

relationships with Indian academics and civil 

society would be an effective way to begin es- 

tablishing these connections. 55,56 These con- 

nections can also provide a perspective on 

research occurring outside of the purview of 

the government, which should prove valuable 

in areas that lack government presence or ca- 

pacity. 


ratories should identify several LCMs or vac- 

cine importers in target countries to see projects 

through to completion in ways that meet quality 

standards. 

Action 3.2.1: Partner with more than one LCM 

while making incentives for LCMs clear 

It will be important to broaden the range of 

potential low-cost manufacturing partners 

that the Hilleman Laboratories’ leadership 

work with to conduct Phase III trials. Mar- 

keting will be also be important to ensure that 

adequate quantities of new vaccines are pro- 


duced and priced at reasonable levels. 

The labs’ leadership should avoid allowing 

a sole manufacturer or firm to function as a 

monopoly in the vaccine market so vaccine 

prices remain affordable and the potential for 

manufacturing failures is not concentrated 

within one firm. Similarly, by working with 

more than one LCM in more than one coun- 

try, the labs’ leaders reduce the risk of hav- 

ing production undermined or delayed by a 

change in government or business climate. To 

make sure LCMs both fulfill obligations and 

that target markets are adequately reached, 

the labs’ leaders should consider embedding 

benchmarks into a competitive bidding pro- 

cess. 57,58 Having an open competitive bidding 

process can be a useful way to build legitima- 

cy and a sense of independence for potential 

partners to feel confident working with the 

labs. Issues concerning pricing and royalties 

paid to the labs should be worked out well 

in advance before signing agreements with 

LCMs. 

Hilleman Laboratories leadership, however, 

should also not assume that LCMs will come 

to them; certain LCMs may be wary of lim- 

ited profit margins in PDPPP-related proj- 

ects targeted toward the developing world. 

To incentivize partnerships, the labs’ leaders 

should consider granting periods of exclusiv- 

ity for new vaccines in exchange for securing 

price guarantees and minimum production 

volume. These agreements would be revoked 

in the event that a low-cost manufacturer is 

unable to uphold a purchase or license agree- 


ment. 

Action 3.2.2: Protect the quality of the Hilleman 

Laboratories’ research and its reputation through 

agreements with LCMs 

Even after turning over a vaccine to another 

entity for development after Phases I and II, 

the end result is a reflection on the Hilleman 

Laboratories, both among decision makers 

determining vaccine policies and vaccine 

consumers. Any agreements between the Hil- 

leman Laboratories and partners carrying 

out later stage development work should con- 

sider including clauses that allow the labs to 

conduct unscheduled and regularly scheduled 

on-site visits to ensure agreement compliance 

and to enforce quality control measures. 


ratories leaders should identify local and inter- 

national public health experts to collect relevant 

epidemiological data through field surveillance. 

27

28 

Action 3.3.1: Collaborate with local government 

officials and international organizations focused 

on data collection rather than create a parallel 

data collection system 

Meaningful assessment of the local infectious 

disease burden to inform target product man- 

ufacture is contingent on collection of accu- 

rate and timely information. Building rela- 

tionships with public health and information 

bureaus in developing countries as well as 

with local representatives from international 

agencies including the WHO and UNICEF 

can help the Hilleman Laboratories make 

strategic decisions while lowering data collec- 

tion costs. Partnerships with these organiza- 

tions can be particularly valuable to raising 

awareness about disease burden and to stimu- 

lating demand for new low-cost vaccines. 

In India, for example, collecting reliable do- 

mestic epidemiological data is one of the key 

challenges facing both the Indian govern- 

ment and the labs’ initiative. The absence of 

reliable data is part of the reason that gov- 

ernment authorities have difficulty taking-up 

new vaccines: without being able to clearly 

demonstrate the impact that vaccines have in 

reducing disease, it has been difficult to make 

the case for government investment in new 

products. 59 Lack of reliable data also allows 

the persistence of unfounded rumors about 

the relative safety of vaccines, which reduces 

the number of vaccines delivered, and leaves 

children vulnerable. 

Action 3.3.2: Determine project portfolio with 

input from epidemiological research entities 

located in developing countries 

The Hilleman Laboratories is not in the busi- 

ness of doing original epidemiological re- 

search and thus should seek out meaningful 

partnerships with entities conducting surveil- 

lance efforts or seeking to improve the land- 

scape of diagnostic information in developing 

countries. The purpose of such partnerships 

should be to ideally inform new projects for 

the labs to take on, not simply to monitor im- 

plementation of new vaccines. To formalize 

these relationships, the labs should enter into 

agreements or contracts with organizations 

that focus on demographic surveillance, 60 in 

target countries. 

4. Sustainability & Marketing 

Considering the expense and risk involved in devel- 

oping vaccines, it is necessary to have substantial 

funding to bring products to the Phase III stage, not 

to mention to market. The initial commitment of 


£90 million over seven years from Merck and the 

Wellcome Trust positions the Hilleman Laboratories 

well to establish company infrastructure and to be- 

gin operations. However, to realistically achieve the 

partnership’s goals, the labs will need financing that 

continues past the initial seven years. 

Long-term funding streams could be diverse and 

come from a variety of sources such as foundations, 

donor governments, academia, the private sector, 

multilateral organizations, and, hopefully, product 

revenue. As the Hilleman Laboratories leaders seek 

funding it will be important to maintain a balance 

between money that is donated for a specific proj- 

ect and funds that can be used unconditionally as the 

labs see fit. If too many funders require that their 

contributions be channeled toward specific projects, 

it may constrain the labs’ ability to direct funding as 

necessary. This section offers suggestions for how to 

promote sustainability while maintaining the labs’ 

commitment to addressing burden of disease in the 

developing world. 

RECOMMENDATION 4.1: Merck and the 

Wellcome Trust should consider further funding 

of the Hilleman Laboratories to ensure project 

completion and to reduce distractions from core 

project development activities. 

It is vital that the Hilleman Laboratories’ funding 

structure reflects the long time horizon of both 

vaccine development and optimization projects; 

on average vaccine development requires over 

ten years. 61 The initial investment from Merck 

and the Wellcome Trust will enable the labs to 

get off the ground and hopefully make significant 

progress toward a first product. Nevertheless, 

funding needs will continue beyond the initial 

phase. To that end, we suggest that Merck and 

the Wellcome Trust provide additional funding 

beyond the initial £90 million if certain pre-de- pre-de- 

termined benchmarks are met. 

Continued investment can and should be tied to 

the labs’ ability to demonstrate achievement of 

these core objectives over the course of their start- 

up. The task force recommends that Merck and 

the Wellcome Trust collaborate with leadership 

at the Hilleman Laboratories to establish realistic 

objectives that can be monitored throughout the 

start-up phase. While it will be important for the 

labs to have lofty, overarching goals that drive its 

mission, these benchmarking objectives should 

be kept at a level that will be achievable during 

the initial phase. For example, funders may set 

short-term objectives for the labs like: finalizing 

siting arrangements, hiring staff members, mak- 

ing significant progress on selected projects, initi- 

ating partnerships with the Indian government, 


29

30 

and so on. The second round of funding from the 

two partners could be contingent on whether the 

labs are able to meet such goals or, at a minimum, 

if they can show that they are taking actions to 

address the reasons they have not been able to 

achieve them. 

This recommendation is not meant to discount 

the role of external funding streams for the labs. 

The intent, however, is to ensure that the Hille- 

man Laboratories have a steady stream of core 

funding that allows for infrastructure building 

concurrent to product development. Moreover, 

if this second round of funding allows the labs 

to reach a point where they are generating suf- 

ficient revenue to sustain a significant portion of 

their operations, human and financial resources 

that would otherwise be channelled towards 

grant writing and fundraising could be freed up 

for research and product development. Finally, 

setting benchmarks has merit in its own right, as 

discussed in the Mission & Activities section, in 

that it establishes a culture of accountability. 

RECOMMENDATION 4.2: Once products 

are developed, Hilleman Laboratories leadership 

should assess the potential of tiered pricing strat- 

egies so that markets in both lower and middle- 

income countries can access products. 

According to a 2002 report, developed country 

markets comprise 82 percent of the vaccine in- 

dustry revenue but only 12 percent of the vol- 

ume. 62 Differential pricing (also called “tiered 

pricing”) is one strategy for enabling low-income 

countries or other purchasers to access products 

at prices their respective markets can bear. By 

lowering the price of these products in low-in- 

come settings, vaccine manufacturers can capi- 

talize on a tremendous opportunity for sales. In 

fact, because tiered pricing expands the share of 

potential purchasers, it could reduce prices across 

the board (even in high-income country settings) 

because of efficiencies derived from economies 

of scale. 63 The task force therefore recommends 

that the labs pursue a tiered pricing system for 

their products. Explicit pricing agreements be- 

tween the labs and partner LCMs must be well 

defined before the partnerships are set. 

Given the economic diversity within India, the 

expanding middle class, and the fact that 80 

percent of the health sector is private, 64 the labs 

would not need to look far to implement tiered 

pricing. India’s robust demand for private health 

care 65 suggests that while there are certainly large 

numbers of extremely impoverished citizens, 

there is nevertheless a market that could pay for 

the types of products that the labs might develop. 


The natural urban-rural poverty divide provides 

a useful natural market segmentation to aid in 

tiered pricing. Before pursuing this approach in 

India (or any country), however, leaders of the 

Hilleman Laboratories (or perhaps a separately 

appointed entity) should conduct rigorous will- 

ingness-to-pay studies to ensure that pricing re- 

flects true demand and capacity. Furthermore, 

it will be necessary to determine whether trade 

laws will allow for this differential pricing across 

states in India or other countries. Finally, it will be 

necessary to assess whether bulk purchases made 

by the GAVI Alliance/UNICEF/PAHO can be 

segmented to allow for inter-country tiered pric- 

ing. While these types of analysis may go beyond 

the purview of the labs, it is nevertheless a topic 

leaders of the labs should discuss when partner- 

ing with manufacturers. 

RECOMMENDATION 4.3: Leaders of the 

Hilleman Laboratories should communicate with 

and work closely with government and non-gov- 

ernment partners to foster demand for its prod- 

ucts. 

Action 4.3.1: In the longer term, reach out to 

governments of both middle income countries 

that may be interested in the laboratories’ 

products 

Hilleman Laboratories CEO, Dr. Altaf Lal, 

has indicated that eventually the labs may 

seek to create revenue by marketing products 

at higher prices in middle-income countries, 

in line with the tiered pricing strategy de- 

scribed earlier. This revenue could conceiv- 

ably offset losses from lower-priced products 

in developed countries. Though this strat- 

egy may not be fully implemented for many 

years, the laboratories leadership should not 

simply assume that middle-income countries 

will be interested in candidate products and 

instead, begin to establish relationships with 

middle-income countries now, with the goal 

of attracting LCMs, creating competition, 

and driving down costs. In addition, the pro- 

cess of introducing products in these contexts 

might be very different from marketing tac- 

tics used in developing country contexts (e.g. 

marketing may need to be directed to insur- 

ers rather than to government ministries). 

Action 4.3.2: Develop relationships with entities 

such as the GAVI Alliance, UNICEF and PAHO to 

ensure product procurement 

The GAVI Alliance and UNICEF and 

PAHO are three organizations that demand 

a significant number of vaccines for low- and 

middle-income countries. From 2000-2005, 

GAVI’s Immunisation Services Support 

(ISS) distributed 2.4 million doses of DTP3 


31

32 

to children worldwide. 66 In 2009, UNICEF 

procured US$390 million worth of vaccines 

to 63 countries for GAVI. 67 PAHO also pur- 

chases large amounts of vaccines through its 

revolving fund for a broader economic base 

that includes both developing and middle- 

income countries. Because GAVI, UNICEF 

and PAHO are key players in the world de- 

mand for vaccines, especially to the develop- 

ing world, the Hilleman Laboratories leaders 

must invest in the labs’ relationship with these 

entities. The labs should have a specific and 

targeted approach to working with GAVI, 

UNICEF and PAHO to create and secure a 

strong working relationship with the goal of 

product procurement. 


The task force believes that addressing the recom- 

mendations in the previous section will help to set 

the Hilleman Laboratories on a path toward success. 

Even so, there are other issues that will pose ongoing 

challenges for the labs and for which solutions are not 

immediately evident. In meetings, experts and practi- 

tioners flagged the following items for labs leadership, 

in partnership with Merck and the Wellcome Trust, 

to carefully consider moving forward. 

Intellectual Property 

Based on the partnership and funding from Merck, 

the task force understands why Merck has the right 

of first refusal on products created by the Hilleman 

Laboratories. However, the labs’ leadership should be 

aware that this agreement might discourage LCMs 

or even industry partners from collaborating with the 

labs. Potential partners might believe that Merck will 

ultimately reap the rewards of the labs regardless of 

how products fare or partner contributions. Further, 

if Merck does not choose to pursue a particular pro- 

ject, partners may be suspect of the viability or mar- 

ketability of a potential project. 

Working in India 

India offers a great deal of opportunities including 

Ongoing Challenges 

work force, development capabilities and substantial 

markets for potential products, but it is undeniably 

a challenging environment. For example, there are a 

number of low-cost manufacturers in India that over- 

see Phase I and II activities, like the Serum Institute 

of India Ltd. The Hilleman Laboratories runs the 

risk of being seen as a competitor to these entities, 

even though opportunities will presumably exist for 

collaboration during Phase III and beyond. 

In addition, the regulatory environment in India is 

daunting. Officials from the Ministry of Health in- 

dicated the significant hurdles associated with enter- 

ing the Expanded Programme on Immunization in 

the country, even after WHO pre-qualification. This 

commentary suggests that even if the labs produce a 

candidate vaccine for which there is substantial need 

and demand, it does not necessarily mean that the 

government will be quick to procure the product. For 

example, the Hepatitis B vaccine was sold on the pri- 

vate market for some time before entering the EPI in 

India, despite WHO support. 68 

Part of the challenge in entering the EPI and in moni- 

toring vaccine safety is that epidemiological research 

and disease surveillance data is relatively weak in In- 

dia. 69 Because of limited data, it can be difficult to 

make the case that vaccines need to be introduced. 

Furthermore, sometimes officials believe that because 

of scarce resources, it makes sense to invest in prod- 


33

34 

ucts that address diseases with high mortality out- 

comes, not those that address diseases which substan- 

tially reduce quality of life but do not necessarily lead 

to immediate death. 70 

Perceptions Associated with Siting 

As flagged in the decentralized operations section, 

one question that will continue to be relevant to the 

Hilleman Laboratories during its beginning stages is 

the perception associated with its location in India. 

The labs have sought to be recognized as an initia- 

tive aimed at addressing the global burden of disease, 

not just diseases in India. The labs leadership should 

capitalize on all that India has to offer: a wide array 

of potential LCMs, scientific talent, and proximity to 

need, but if the Hilleman Laboratories is to become 

a global presence, it must carefully balance its actions 

to best maximize the benefit of being in India with- 

out letting its geographic location limit partnerships 

or marketing efforts. 


Closing the global gap in vaccine coverage will re- 

quire initiative and commitment equal to the scope 

of this monumental health challenge. The Hilleman 

Laboratories represent the type of innovation, col- 

laboration, and cooperation required to bring life- 

saving vaccines to untapped markets in many of the 

world’s poorest communities. 

As this report has shown, easing the global burden 

of disease is neither easy nor without risk. To that 

end, the authors have sought to highlight both the 

opportunities and potential challenges facing Merck 

and the Wellcome Trust as they identify the mission 

of the Hilleman Laboratories and define its market 

niche. In meeting with a diverse set of stakeholders, 

the task force broadened its understanding of the is- 

sues and opportunities that the labs will face. These 

discussions helped generate recommendations that 

the task force hopes can narrow the laboratories’ fo- 

cus, and better position the labs to make a meaning- 

ful and sustainable impact in reducing disease bur- 

den in developing countries. 

No one intervention or initiative can mitigate the 

challenges posed by infectious disease worldwide. 

Part of the value of the Hilleman Laboratories, 

therefore, is its stated objective not simply to pro- 

duce products, but rather to unite a diverse set of 

individuals and organizations in pursuit of a shared 

objective. Though it will not be without its flaws and 

Conclusion 

challenges, the task force is confident that the Hille- 

man Laboratories have a unique opportunity to lev- 

erage their position as a public-private entity, and to 

create important new vaccines while simultaneously 

galvanizing a diverse set of global health actors in a 

sustained effort to reduce the global burden of infec- 

tious disease. 


35

36 

Date Location Meetings 

• Dr. Mark Feinberg 

September 30, 2010 Princeton, NJ 

Vice President for Medical Affairs and Policy in 

Merck Vaccines and Infectious Diseases at Merck 

& Co., Inc. 

• Dr. Peter Agre 

October 7, 2010 Princeton, NJ 

Nobel Laureate, Director of the Johns Hopkins 

Malaria Research Institute 

November 1, 2010 London, UK • Wellcome Trust 

November 3, 2010 



Appendix 1: Timeline of Meetings 

• Dr. Ajay Khera 

Deputy Commissioner, MCH Ministry of Health 

& Family Welfare, Government of India 

• Panacea Biotec 

Delhi, India 

• Officials from 

Polio Surveillance Office 

• Dr. Vinod Paul 

Chief of Pediatrics, All India Institute of Medical 

Science 

Seoul, South Korea • IVI officials 

• Dr. N.K. Ganguly 

Former Director General of Indian Council of 

General Research 

Delhi, India 

• Dr. Shirshendo Mukherjee 

Strategic Adviser, R&D Initiative, India Technology 

Transfer, Wellcome Trust 

• Officials at US Embassy Meetings with 

staff from Apollo Healthcare 

Seoul, South Korea • IVI officials 

• Dr. Altaf Lal 

Delhi, India 

CEO of the Merck Wellcome Trust Hilleman 

Laboratories 

Seoul, South Korea 

• 

• 

IVI 

MOFAT 

November 12, 2010 West Point, PA • Site visit, Merck Gardasil Plant 

November 18, 2010 Princeton, NJ 

• Dr. Jeremy Farrar 

Director of the Oxford University Clinical Re- 

search Unit (OUCRU), Ho Chi Minh City, Viet- 


nam. 

December 17, 2010 West Point, PA • Merck officials

Recent Vaccine Innovations and Related 

Opportunities 

This section reviews three recent vaccine innovations 

and identifies opportunities for further funding/poli- 

cy interventions that the Hilleman Laboratories may 

be interested in exploring independently or in part- 

nership with other entities. 

HPV: 

In 2005, 260,000 women died from cervical can- 

cer, while another 500,000 women became in- 

fected with the human papillomarivus (HPV), a 

major cause of cervical cancer. 71 While 85 per- 

cent of deaths from cervical cancer occur in the 

developing world, the development of HPV vac- 

cines offers the possibility of reversing this trend. 72 

A series of challenges involved with introducing 

the vaccine into the developing world means the 

vaccine remains largely out of the hands of those 

who need it most in low resource settings. As with 

many of the existing available vaccines, “coun- 

tries that need the largest quantity of the HPV 

vaccine will be the least likely to afford it.” 73 

While WHO recommends that the target popu- 

lation be 9-13 year old adolescent girls, 74 build- 

ing herd immunity will require the vaccination of 

girls and boys. In developing countries, this seg- 

ment of the population is relatively healthy and 

Appendix 2 

therefore, rarely comes into contact with health 

systems. Furthermore, the current high cost of 

production for Gardasil, (especially compared to 

Ceravix), means that optimization would have to 

occur to lower the end user cost. 

Rotavirus: 

Rotavirus is the leading cause of severe diarrhea 

in infants and children worldwide. In the United 

States, before the rotavirus vaccine was intro- 

duced in 2006 for all infants, almost all children 

were infected with rotavirus before their fifth 

birthday. 75 Symptoms include severe diarrhea, 

sometimes vomiting, and fever. 76 These symp- 

toms can be life threatening in settings with in- 

adequate sanitation, nutrition, and lack of access 

to medical care. The WHO estimates that diar- 

rhea caused by rotavirus infection claims more 

than 500,000 deaths among children less than 

five years of age, approximately five percent of 

all deaths of children in that age group. 77 There 

are currently two vaccines for rotavirus, RotaTeq, 

which had clinical trials and was approved for the 

market in 2006, 78 and Rotarix®, which also had 

clinical trials that showed efficacy among African 

children in 2010. 79 In 2009, the WHO recom- 

mended both of these vaccines for all children 

worldwide. 80 The current challenge is to make 

these vaccines part of every country’s national 


37

38 

immunization program, and to sustainably man- 

ufacture and distribute them worldwide. Today, 

only 19 81 of the 193 member states have rotavirus 

in their immunization schedules, and the WHO 

does not monitor rotavirus in its report of vac- 

cine-preventable diseases. 

Cholera: 

Cholera affects about 3-5 million people each 

year, 100,000-200,000 of whom will die. 82 While 

seen in pockets of the developed world, cholera is 

most common in impoverished countries in Sub- 

Saharan Africa and South Asia, and also one 

of the most under-reported diseases by govern- 

ments. 83 While safe hygiene practices can prevent 

cholera, the development and distribution of 

low-cost cholera vaccines can be the best solu- 

tion to curb its spread. There are challenges to 

administering the vaccine, however, and in times 

of emergency when a cholera outbreak occurs, 

administering the required two doses of the vac- 

cine is nearly impossible owing to logistical and 

operational difficulties. 84 

Several vaccines have been developed, tested 

and licensed but some were short-lived because 

of sub-par efficacy and side effects while others, 

such as the WC/rBS vaccine, are found to be ef- 

ficacious. 84 Dukoral is the more expensive, more 

efficacious, WHO pre-qualified oral vaccine that 

is currently in use, while cheaper alternatives, 

such as Shanchol and ORC Vax, are un- 

dergoing scrutiny and have yet to be WHO pre- 

qualified. Emerging outbreaks like that in Haiti 

will continue to foster the demand for a single- 

dose efficacious cholera vaccine. 


1 Lopez, Alan D, C. D. Mathers, M. Ezatti, D. 

Jamison, and C.J. Murray. “Global and regional 

burden of disease and risk factors, 2001: systematic 

analysis of population health data.” The Lancet 367, 

no. 9524 (2006): 1747-1757. 

2 Ibid. 

3 Ibid. 

4 In a study of pneumococcal and haemophilus 

meningitis at Ethio-Swedish Childrens’ Hospital in 

Addis Ababa, cases of meningitis suspected by a 

physician were tested by a lumbar puncture procedure 

in an in-patient setting. In a Mozambique 

study of pneumococcal disease, cases of meningitis 

were thought to be underestimated since children 

demonstrating clinical signs of meningitis did not 

always have cerebrospinal fluid samples tested. 

(Muhe, Lulu, and K.P. Klugman. “Pneumococcal 

and Haemophilus Influenzae meningitis in a children’s 

hospital in Ethiopia.” Tropical Medicine and 

International Health 4, no. 6 (1999): 421-427.) 

5 Such factors that may not be accounted for include 

ethnic or tribal relationships that extend over 

national borders as is the case with the Hausa-Fulani 

ethnic group cross border interactions between 

Niger and Nigeria, which complicates measles 

eradication efforts in Niger. Another example concerns 

the contrast between the seasonality of measles 

and rotavirus, which both differ across African 

countries, and the incidence of measles in the United 

Kingdom, which is biennial, highly seasonable, 

and fueled by the school year. (Bharti, N, A Djibo, 

MJ Ferrari, RF Grais, AJ Tatem, CA McCabe, ON 

Bjornstad, and BT Grenfell. «Measles hotspots in 

Niger.» Epidemiology and Infection 138 (2010): 1313.) 

6 Ferrari, Matthew J, Rebecca F Grais, Nita Bharti, 

Andrew JK Conlan, Ottar N Bjornstad, Lara J 

Wolfson, Philippe J Guerin, Ali Djibo, and Bryan T 

Grenfell. “The Dynamics of Measles in sub-Saharan 

Africa.” Nature 451 (2008): 681. 

7 Bharti, N, A Djibo, MJ Ferrari, RF Grais, AJ Tatem, 

CA McCabe, ON Bjornstad, and BT Grenfell. 

“Measles hotspots in Niger.” Epidemiology and 

Infection 138 (2010): 1313. 

References 

8 WHO. “Challenges in global immunization 

and the Global Immunization Vision and Strategy 

2006-2015.” Weekly Epidemiological Record 12, no. 81 

(2006): 190-195. 

9 Wolfson, Lara J, Francois Gasse, Shook-Pui Lee- 

Martin, Patrick Lydon, Ahmed Magan, Abdelmajid 

Tibouti, Benjamin Johns, Raymond Hutubessy, 

Peter Salama, and Jean-Marie Okwo-Bele. “Estimating 

the costs of achieving the WHO-UNICEF 

Global Immunization Vision and Strategy, 2006- 

2015.” Bulletin of the World Health Organization 86, 

no. 1 (2008): 27-39. 

10 New vaccines require between $300 and $800 

million to develop. (Plotkin, Stanley A. “Vaccines: 

past, present, and future.” Nature Medicine 11, no. 4 

(2005): S5-S11 

11 Wolfson, Lara J, Francois Gasse, Shook-Pui 

Lee-Martin, Patrick Lydon, Ahmed Magan, Abdelmajid 

Tibouti, Benjamin Johns, Raymond Hutubessy, 

Peter Salama, and Jean-Marie Okwo-Bele. 

“Estimating the costs of achieving the WHO-UNI- 

CEF Global Immunization Vision and Strategy, 

2006-2015.” Bulletin of the World Health Organization 

86, no. 1 (2008): 27-39. 

12 Lydon, P, R Levine, M Makinen, L Brenzel, V 

Mitchell, JB Millstien, L Kamara, and S Landry. 

“Introducing new vaccines in the poorest countries: 

What did we learn from the GAVI experience with 

financial sustainability?.” Vaccine 26, no. 51 (2008): 

6706-6716. 

13 Plahte, Jens. “Tiered pricing of vaccines: a winwin-win 

situation, not a subsidy.” The Lancet 5, no. 

1 (2005): 58-63. 

14 This study is based on data from the Global 

Funding of Innovation for neglected diseases (G- 

Finder) project, which surveyed 2007 global investments 

into R&D of products for neglected diseases. 

(Moran, M, J Guzman, AL Ropars, and A Illmer. 

“The role of Product Development Partnerships in 

research and development for neglected diseases.” 

International Health Journal 2, no. 2 (2010): 114-122.) 

15 McCoy, David, Gayatri Kembhavi, Jinesh Patel, 

and Akish Luintel. “The Bill & Melinda Gates 


39

40 

Foundation’s grant-making programme for global 

health.” The Lancet 373, no. 9675 (2009): 1645- 

1653. 

16 Bryce, EA, J Ford, L Chase, C Taylor, and S 

Scharf. “Sharps injuries: Defining prevention priorities.” 

American Journal of Infection Control 27, no. 5 

(1999): 447-452. 

17 Holodnick, Cherie, and Violet Barkauskas. 

“Reducing Percutaneous Injuries in the OR by 

Educational Methods.” Association of Operating Room 

Nurses 72 (2000): 461-476. 

18 Setia, Sabeena, Hugh Mainzer, Michael Washington, 

Gary Coil, and Robert Snyder. “Frequency 

and causes of vaccine wastage.” Vaccine 20, no. 7-8 

(2002): 1148-1156. 

19 Arya, SC, and N Agarwal. “Relationship between 

vaccine vial monitors and cold chain infrastructure 

in a rural district of India.” Rural Remote 

Health 7, no. 1 (2007): 730. 

20 Ellenberg, SS, and RT Chen. “The complicated 

task of monitoring vaccine.” Public Health 

Reports 112 (1997): 10-21. 

21 Hoffman, Howard J, Jehu C Hunter, Karla Damus, 

Jean Pakter, Donald R Peterson, Gerald van 

Belle, and Eileen G Hasselmeyer. “Diphtheria-Tetanus-Pertussis 

Immunization and Sudden Infant 

Death: Results of the National Institute of Child 

Health and Human Development Cooperative 

Epidemiological Study of Sudden Infant Death 

Syndrome Risk Factors.” Pediatrics 79, no. 4 (1987): 

598-611. 

22 Stetler, Harrison C, John R Mullen, John-Paul 

Brennan, John R Livengood, Walter A Orenstein, 

and Alan R Hinman. “Monitoring system for adverse 

events following immunization.” Vaccine 5, no. 

3 (1987): 169-174. 

23 A 2010 report from Moran et al indicates that 

in 2007, 42.0% of global funding for neglected 

diseases was funneled to various types of PDPs. 

This percentage excludes the National Institute of 

Health because it is the largest funder of research 

into neglected diseases, but directs a relatively small 

portion of its funding toward PDPs (.4%) on account 

of large internal R&D operations. Other 

funding went to biotechnology firms, universities, 

industry, and non-profit entities. (Moran, M, J 

Guzman, AL Ropars, and A Illmer. “The role of 

Product Development Partnerships in research and 

development for neglected diseases.” International 

Health Journal 2, no. 2 (2010): 114-122.) 

24 Meningitis Vaccine Project. “Meningitis Vaccine 

Project: Our strategy and principles.” http:// 

www.meningvax.org/principles.php (accessed January 

11, 2011). 

25 LaForce, Marc, K Konde, S Viviani, and M 

Preziosi. “The Meningitis Vaccine Project.” Vaccine 

25S (2007): A97-A100. 

26 This document offered highly detailed recommendations 

including that vaccines should be administered 

in a single dose and that mass vaccination 

campaigns should occur in two phases: first 

targeting individuals age 9 months to 30 years and 

then be introduced into routine epidemiological 

procedures at 9 months, combined with measles or 

yellow fever vaccines. “Joint Recommendations for 

the Development and Introduction of Conjugate 

Vaccines Against Meningococcal Disease in the African 

and Eastern Mediterranean Regions,” available 

at http://www.path.org/files/WHO-meningjoint-recs.doc. 

27 LaForce, Marc, K Konde, S Viviani, and M 

Preziosi. “The Meningitis Vaccine Project.” Vaccine 

25S (2007): A97-A100. 

28 Ibid. For clinical and laboratory work, MVP 

has also employed other Indian-based partners: 

B.Y.L. Nair Charitable Hospital, India (PsA- 

TT-001); Nizam’s Institute of Medical Sciences, 

India (PsA-TT-001); King Edward Memorial Hospital 

(KEM), India. Finally, MVP is working with 

India-based DiagnoSearch Life Sciences to oversee 

data collection and statistical analysis and clinical 

trial monitoring for all trials in India. 

29 Gothefors, L, M Troye-Blomberg, and L Ake 

Persson. “The relevance and future role of the 

International Vaccine Institute (IVI) 2000-2006.” 


Swedish International Development Agency Department for 

Research Cooperation 07/09 (2007): 21. 

30 Personal communication with Mr. Kweon Kihwan, 

Representative from Korea’s Ministry of 

Foreign Affairs and Trade, Seoul, South Korea (5 

November 2010). 

31 “International Vaccine Institute.” International 

Vaccine Institute. http://www.ivi.int (accessed January 

11, 2011). 

32 “Strategic Plan 2008-2012.” The IVI Newsletter 

20 (2009). http://www.ivi.int/newsletter/eng/ 

disp/news_view.asp?snlid=99 (accessed January 7, 

2011). 

33 “Annual Report.”International Vaccine Institute 

(2009). http://www.ivi.int/event_news/news_ 

view.asp?enid=114 (accessed January 11, 2011). 

34 Dr. John Clemens, General Director, IVI, 

Seoul, South Korea, interview by authors November 

4, 2010. 






36 “Annual Report.” International Vaccine Institute 

(2009). http://www.ivi.int/event_news/news_ 

view.asp?enid=114 (accessed January 11, 2011). 

37 “Strategic Plan 2008-2012.” The IVI Newsletter 

20 (2009). http://www.ivi.int/newsletter/eng/ 

disp/news_view.asp?snlid=99 (accessed January 7, 

2011). 






39 “Wellcome Trust and Merck Launch First of its 

Kind Joint Venture to Develop Affordable Vaccines 

for Low-income Countries.” MSD Wellcome Trust 

- Hilleman Laboratories. http://www.hillemanlaboratories.in/news/ 

(accessed September 17, 2009). 

40 Stephens, Joe. “As Drug Testing Spreads, Profits 

and Lives Hang in Balance.” The Washington Post, 

December 17, 2000, sec. A. http://www.washingtonpost.com/ac2/wp-dyn/A11939-2000Dec15 

(accessed January 11, 2011). 

41 Buse, K, and A Harmer. “Seven habits of highly 

effective global public-private health partnerships: 

Practice and potential.” Social Science & Medicine 64, 

no. 2 (2007): 262. 

42 Lal, Dr. Altaf. Interview by authors. Personal 

interview. New Delhi, India, November 5, 2010. 

43 “Press Release: Wellcome to India.” Wellcome 

Trust. http://www.wellcome.ac.uk/News/2008/ 

News/WTX051323.htm (accessed January 11, 

2011). 

44 “Research & Development for Affordable 

Healthcare in India | Wellcome Trust.” Wellcome 

Trust. http://www.wellcome.ac.uk/Funding/ 

Technology-transfer/Awards/R-and-D-for-Affordable-Healthcare-in-India/index.htm 

(accessed 

January 12, 2011). 

45 Serdobova, Irina, and M Kieny. “Assembling 

a Global Vaccine Development Pipeline for Infectious 

Diseases in the Developing World.” American 

Journal of Public Health 96 (2006): 9. 

46 Jezek, J, D Chen, L Watson, J Crawford, S Perkins, 

A Tyagi, and L Jones-Braun. “A Heat-Stable 

Hepatitis B Vaccine Formulation.” Human Vaccines 

5, no. 8 (2009): 529-35. 

47 Dugger, Celia W. “New Meningitis Vaccine 

Brings Hope of Taming a Ravaging Illness in Africa.” 

The New York Times, December 4, 2010. 

48 According to G-Finder, 42.3% of R&D funding 

has been directed toward HIV/AIDS, 18.3% 

of funding toward Malaria, and 16.03% toward 

Tuberculosis; these three diseases constituted 80% 

of the total global R&D funding toward neglected 

diseases. (Moran, Mary, Javier Guzman, Anne- 

Laure Ropars, Alina McDonald, Nicole Jameson, 

Brenda Omune, Sam Ryan, and Lindsey Wu. “Neglected 

Disease Research and Development: How 

much are we really spending?” Public Library of Sci- 


41

42 

ence 6, no. 2 (2009).) 

49 Rochlin, D. “From Polysaccharides to Proteins: 

The Challenge of Vaccination Against Serogroup 

B Meningococcal Disease.” Princeton University Thesis 

(2010): 113. 

50 IVI Website “International Vaccine Institute 

Organizational Structure.” International Vaccine 

Institute. http://www.ivi.int/about_us/acheivements.html 

(accessed January 12, 2011). 

51 Despite objections to the fact that the RV144 

trial involved the combined use of two vaccines 

which individually did not show any protective 

effect, a large 16,000 person trial was conducted 

to test for a synergistic effect. Although the initial 

results were hailed as a “qualified success”, closer 

examination of the data revealed that only in very 

particular statistical tests was a marginal rate of significance 

reached. These results only serve to bolster 

the claims that the NIH funds used were a waste 

of resources. (Burton, DR, et al, “Public Health: A 

Sound Rationale Needed for Phase III HIV-1 Vaccine 

Trials.” Science 303, no. 5656 (2004): 316.) 

52 Cohen, J. “HIV/AIDS Research. Beyond 

Thailand: Making Sense of a Qualified AIDS Vaccine 

‘Success’.” Science 326, no. 5953 (2009): 652-3. 

53 Preferential tax treatments include the Government 

of Korea granting tax-exempt status to 

the International Vaccine Institute and the Government 

of India’s Industrial R&D Promotion 

Program, which allows manufacturers, including 

pharmaceutical companies like Panacea Biotech, 

an India-based vaccine manufacturer, to deduct up 

to 150% of costs on its research and development 

facilities among other tax-advantaged opportunities. 

54 Mukherjee, Dr. Shirshendo. Strategic Adviser, 

R&D Initiative, India Technology Transfer, Wellcome 

Trust. Interview by authors. New Delhi, India, 

November 4, 2010. 

55 Ganguly, Dr. N.K., Former Director General 

of Indian Council of General Research. Interview 

by authors. New Delhi, India, November 4, 2010. 

56 Mukherjee, Dr. Shirshendo, Strategic Adviser, 

R&D Initiative, India Technology Transfer, Wellcome 

Trust. Interview by authors. New Delhi, India, 

November 4, 2010. 

57 Favorov, Dr. Michael, Deputy Director General 

Translational Research Division, International 

Vaccine Institute. Interview by authors. Seoul, 

South Korea, November 4, 2010. 

58 Smith, Dr. Greg, Production and Quality Control 

Coordinator, International Vaccine Institute. 

Interview by authors. Seoul, South Korea, November 

4, 2010. 

59 Khera, Dr. Ajay. Interview by authors. New 

Delhi, India, November 3, 2010. 

60 Baiden, Frank, Abraham Hodgson, and Fred 

Binka. “Editorial: Demographic surveillance 

sites and emerging challenges in international 

health.” Bulletin of the World Health Organization 84, 

no. 3 (2006). 

61 Grabowski, Henry. “Encouraging The Development 

Of New Vaccines.” Health Affairs 24, no.3 

(2005): 697-700. 

62 Whitehead, P and Pasternak, A “Lessons 

learned: new procurement strategies for vaccines.” 

Report to the GAVI Board, June 2002. Boston: 

Mercer Management Consulting 

63 Ibid. 

64 PriceWaterhouseCoopers Health Care Group, 

“Emerging Market Report: Health in India 2007.” 

PriceWaterhouseCoopers (2007). 

65 Bardhan, Pranab “The State Of Health Services 

In China And India: A Larger Context.” 

Health Affairs 27, no. 4 (2008): 933-936. 

66 Chee, G., Molldrem, V., Hsi, N., and Chankova, 

S. “Evaluation of the GAVI Phase 1 Performance 

(2000-2005).” Report prepared for GAVI Alliance, 

(October 2008). 

67 UNICEF website “GAVI” http://www.unicef. 

org/supply/index_gavi.html (accessed December 

29, 2010). 


68 Ganguly, Dr. N.K. Former Director General of 

Indian Council of General Research, Interview by 

authors. New Delhi, India, November 4, 2010. 

69 Vinod, Dr. P., Chief of Pediatrics, All India 

Institute of Medical Sciences, interviewed by authors, 

New Delhi, India, November 3, 2010. 

70 Khera, Dr. A., Deputy Commissioner, MCH 

Ministry of Health & Family Welfare, New Delhi, 

India, November 3 2010. 

71 WHO “Human papillomavirus vaccines WHO 

position paper.” Weekly epidemiological record 84 no. 

15 (April 9, 2009): 117–132. 

72 Ibid. 

73 IAVI and PATH “HPV vaccine adoption in developing 

countries: Cost and financing issues” New 

York: IAVI (2007): 1-40. Available at: http://www. 

rho.org/files/IAVI_PATH_HPV_financing.pdf. 

74 WHO “Human papillomavirus vaccines WHO 

position paper.” Weekly epidemiological record 84 no. 

15 (April 9, 2009): 117–132. 

75 Centers for Disease Control and Prevention 

website. “Rotavirus Homepage” http://www.cdc. 

gov/rotavirus/index.html (accessed October 28, 

2010). 

76 Kossinets, G. and Watts, D.J., “Origins of Homophily 

in an Evolving Social Network.” American 

Journal of Sociology 115 (2009): 405-450. 

77 Chandran A., Fitzwater S., Zhen A., and Santosham 

M., “Prevention of Rotavirus Gastroenteritis 

in Infants and Children: Rotavirus Vaccine 

Safety, Efficacy, and Potential Impact of Vaccines.” 

Biologics 9, no. 4 (2010): 213-229. 

78 Ruiz-Palacios, G., et al., “Safety and Efficacy 

of an Attenuated Vaccine Against Severe Rotavirus 

Gastroenteritis.” The New England Journal of Medicine 

354 (2006): 11-22. 

79 Madhi, S.A., et al., “Effect of Human Rotavirus 

Vaccine on Severe Diarrhea in African Infants.” 

The New England Journal of Medicine 362 (2010): 289- 

298 

80 WHO, “Global use of rotavirus vaccines recommended.” 

Joint News Release of WHO, GAVI, 

and PATH on June 5, 2009. Available at: http:// 

www.who.int/mediacentre/news/releases/2009/ 

rotavirus_vaccines_20090605/en/index.html (accessed 

December 27, 2010). 

81 South Africa, Brazil, Canada, Colombia, Ecuador, 

El Salvador, Honduras, Mexico, Nicaragua, 

Panama, U.S., Venezuela, Bahrain, Qatar, Austria, 

Belgium, Finland, Luxembourg, Australia, and Palau. 

82 WHO website, “Cholera Factsheet” http:// 

www.who.int/mediacentre/factsheets/fs107/en/index.html 

(accessed December 27, 2010). 

83 Ibid. 

84 WHO Department of Immunisation, Vaccines, 

and Biologics, “2006 Report of the Steering Committee 

on Dengue and other Flavivirus Vaccines including 

Minutes of the Steering Committee Meeting.” 

Geneva: WHO (May 15-17, 2006). 


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