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Total transparency, and preparedness—two answers to COVID vaccine side-effects

By Dr N K Arora

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.

Total transparency, and preparedness—two answers to COVID vaccine side-effects

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)

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