FM November2020 Digital P

THE HUNT FOR A VACCINE
Researchers around the world are working at a breakneck
pace to test different types of vaccines to stop COVID-19.
PHASE 1
35
vaccines
vaccines
testing safety
and dosage
PHASE 2
14
in
vaccines
expanded
safety trials
PHASE 3
11
in
vaccines
large-scale
efficacy
tests
LIMITED
6
Vaccines
approved for
early or
ltd use
APPROVED
0
approved
for use
J&J halts
vaccine study
Johnson & Johnson has halted the study
of its experimental COVID-19 vaccine
candidate due to an unexplained illness in
a study participant.
A document sent to outside
researchers running the 60,000-patient
clinical trial states that a “pausing rule”
has been met, that the online system used
to enroll patients in the study has been
closed.
J&J’s vaccine is a single-dose COVID-19
vaccine in phase 3 trials.
In a statement on the decision to
pause the trials J&J said: “It’s important
to have all the facts before we share
additional information.” It added that it
was not always immediately apparent
whether a participant received the vaccine
or a placebo.
The participant’s adverse reaction
was being reviewed by an independent
data safety monitoring board and the
company’s doctors, the New Jersey-based
drugmaker said. It added that serious
adverse events were not uncommon in
clinical trials, and that their frequency
was expected to increase as trial sizes
expanded. J&J said that while it normally
communicates clinical holds to the public,
it does not usually inform the public of
study pauses.
J&J is at present studying its vaccine
candidate in one- and two-dose regimens.
It is unclear which trial the participant was
enlisted in.
J&J is the second company to have
halted COVID-19 vaccine trials in recent
months. AstraZeneca stopped its trial in
September when at least one participant
developed unexplained neurological
symptoms.
EMA panel begins first rolling
review of AstraZeneca’s
COVID-19 vaccine
EMA’s human medicines
committee (CHMP) has started
the first ‘rolling review’ by evaluating
the first batch of nonclinical data of
the COVID-19 vaccine developed by
AstraZeneca in collaboration with
the University of Oxford.
The vaccine is made up of an
adenovirus that has been modified
to contain the gene for making the
SARS-CoV-2 spike protein.
A rolling review is one of the
regulatory tools that the agency
uses to speed up the assessment
of a promising medicine or vaccine
during a public health emergency.
Normally, all data on a medicine’s
effectiveness, safety and quality
and all required documents must
be submitted at the start of the
evaluation in a formal application for
marketing authorization. In the case
of a rolling review, the CHMP reviews
data as they become available from
ongoing studies, before deciding
that sufficient data are available and
that a formal application should be
submitted by the company.
The CHMP’s decision to start
the rolling review of the vaccine is
based on preliminary results from
non-clinical and early clinical studies
suggesting that the vaccine triggers
the production of antibodies and T
cells that target the virus.
Results from large-scale clinical
trials will be assessed in later rolling
review cycles. All the available
data on the safety of the vaccine
emerging from these studies, as well
as data on its quality, will also be
reviewed.
The rolling review will continue
until enough evidence is available
to support a formal marketing
authorization application.
The rolling review process
has been used previously in the
assessment of COVID-19 medicine,
remdesivir.
18 / FUTURE MEDICINE / November 2020