Total transparency, and preparedness—two answers to COVID vaccine side-effects
When recent reports of four people in the US suffering Bell's Palsy post-vaccination for Corona Virus Disease-19 [COVID] in one of the ongoing trials went viral, few had the patience to wait for evidence on whether the condition was caused by the vaccine or not. Despite the US and UK drug regulator's assurance that four cases in forty-thousand people who were part of the clinical trialare not enough data to press the panic button on vaccine, fear had gripped enough people.
Irrespective
of
what
the
investigation
reveals
in
future
to
scientifically
establish
if
indeed
the
cases
of
temporary
facial
paralysis
could
be
attributed
to
vaccine,
many
people
would
have
decided
to
delay
their
decision
for
vaccination.
This
may
not
be
the
last
such
experience,
as
the
world
embarks
on
a
never
before
attempted
exercise
of
vaccinating
elderly
population
and
many
more
with
co-morbidities.
Coincidences
masked
in
COVID
vaccination
Because of the existing vulnerabilities in the health profile of those getting vaccines, the chances of a health condition masking as a side-effect of the vaccine is very high. Those are what we call 'coincidental' events-random in nature but as they followed vaccination, they get associated with vaccine till the air is cleared. It means heart-attacks or strokes or other diseases, which would have happened even without the vaccine in some people, are likely to get linked to the vaccine, just because those events followed vaccination.
As part of massive immunization programmes involving children, we have seen the potential of such scares to create vaccine reluctance in parents who inadvertently increase the health-risks for their child by missing life-saving doses. But here in case of COVID, as we enter uncharted territories in vaccinating so many adults with vulnerable health profiles in such a short-span of time-two aspects are most important-total transparency and full preparedness on our part to monitor, investigate and address side-effects of vaccinations. And most importantly accept if any of the events are truly linked to the vaccine.
For
India,
it's
ready,
steady
and
go
for
vaccinations
along
with
vaccine
safety
surveillance
Not
many
people
know
this,
but
for
almost
a
decade
now
we
have
an
extensive
network
of
AEFI
[Adverse
effect
following
immunisation]
surveillance
and
monitoring
system
with
over
700
district
committees,
as
well
as
state
level
and
national
level
panels
for
children.
Because
this
time,
we
are
dealing
with
adults,
with
many
of
them
suffering
chronic
diseases;
cardiologists,
pulmonologists,
general
physicians
and
neurologists
have
been
inducted
in
the
national
panel
last
month.
More
medical
specialists
are
in
the
process
of
being
inducted
at
state
level
as
well
at
district
level.
Since what is being envisaged right now are different vaccines for COVID, an exhaustive list of possible anticipated side-effects for each probable vaccine is being drawn-up by a national expert committee.
Training of health-workers and doctors in the AEFI surveillance system to identify symptoms of possible side-effects is expected to begin over next few weeks.
Back-end preparations are underway in full swing to enable seamless reporting on a platform where the side-effects occurring any time after the vaccination can be tracked. To distinguish between coincidental events and real adverse events, a baseline survey for different health-conditions such as heart-attacks, strokes, respiratory problems for various age-groups is being conducted. This will alert us to identify 'excess' in adverse health events post vaccination, if any.
We are also designing studies to be conducted at various sites across the country to proactively seek linkages between health conditions and vaccination. One such study will monitor across hospital sites whether number of vaccinated patients presenting one type of disease, exceed the number of non-vaccinated patients. If so, our suspicions around linkages between disease and vaccination will need to be deeply probed. Since we have been conducting similar studies for immunised children since last several years, we have systems in place to do it for adults with some adaptations without delay.
For individuals getting vaccinated, we have to ensure exceptional transparency in communicating about side-effects. More than preparing the individual for all known eventualities, absolute transparency fosters trust. And trust is the most critical currency in any mass vaccination drive, whether it involves children or adults-this is one lesson history has reminded us again and again.
(Author is heading Operations Research Group, a part of the National Task Force set up by Indian Council of Medical Research (ICMR) in response to COVID-19)