Even though there’s nothing in it to be proud of or gloat, being 55 years old, I suffer from numerous medical conditions that typify me as the quintessential high-risk case who can easily contract coronavirus.
Among some of the medical conditions that I need to contend with on a regular basis are cardiac problems (I have had two open-heart surgeries), hypertension, hyperuricemia, hyperlipidaemia and the worst of all chronic fatigue and immune deficiency syndrome.
I suppose this should imminently qualify me to be among the first recipients of one of the Covid-19 vaccines cleared by the DCGI for emergency use in India.
I have managed to stay free from getting infected till now despite staying in Delhi (the city has been among the worst-affected places in the country). So, the quandary is should I embrace the vaccines which seem to have raised more questions than they have answered?
The government itself is saying that the Phase III trial is incomplete. Let alone that, even the safety and efficacy data of phase I and Phase II trial, which are over, are not out in the public domain. So, apart from word of mouth, there’s nothing to substantiate the government’s claim of safety.
The government is asking us to trust the vaccine on the basis of its argument in favour of Atmanirbhar Bharat or the achievement of the country in developing a vaccine but not on the basis of its safety and efficacy report.
So, we have a vaccine for which efficacy is not known and safety is only being claimed but not being scientifically vetted in any way.
At this stage, it would seem agreeing to take a shot of the promised panacea would amount to lending myself voluntarily to be a guinea pig at the altar of the vaccine that gleams amidst so many uncertainties.
I read in the newspaper that one volunteer died in Madhya Pradesh and one is in serious condition. In India, there is already a track record of violation of norms, and the regulators themselves appear regulated, especially in a situation of all round institutional atrophy. Though increasingly getting far from ideal, but still a far greater robustness of scientific and regulatory institutions in western countries offers a greater possibility of documenting failures and seeking redressal.
My second concern is the authenticity of efficacy data which the government has promised to put in the public domain within a month. Now if you see today the active cases are declining. In such a situation rate of infection has been going down. Then how will they generate the authentic efficacy data?
Let’s sa, for example, out of 1,000 people, 500 are given a placebo and the remaining 500 are given a vaccine. Unlike laboratory animals, we cannot possibly deliberately expose these 1,000 people in the control and vaccine groups to the virus so that we can find out how many of them in either group were prevented from getting infected and how many of them remained safe. This is unethical and against the principles of the clinical trial. So, all 1,000 people take all precautions like they wear masks, maintain social distancing and hand hygiene. It means that to test the efficacy of the vaccine in these 1,000 volunteers we shall have to depend on the natural course of infection happening in their environment.
When the infections are declining, then how can the government promise to produce the efficacy data in a month or so?
To find out efficacy accurately in such a situation, the sample size needs to be very large and the time period of the study also be longer. When the epidemic curve was on the rise then even a smaller sample size would have served the purpose.
My third objection is that all these things are happening in utter defiance of public health logic and vaccine science.
It is not possible that the government is not aware of it or can’t get access to the best medical opinion. They are conveniently ignoring it as has been evident through numerous examples during the course of this pandemic. This shows that it has a different agenda.
I think that when the government is being pushed into a corner because of other developments that are there, it has no option but to harp on vaccine just to divert the attention of the people from the issues which it is finding difficult to address. It looks like the government is not concerned to protect people but protect themselves behind the vaccine shield. This is a dangerous game plan drought with the following risks.
My fourth objection is that when there is no assurance of safety and if it causes any side effect or adverse reaction to me or any other recipient, suspicions are bound to be raised among common people vis a vis Covid vaccine, as also other essential vaccines despite these having proven efficacy.
My fifth point is that the government has granted emergency use permission. What is the meaning of that?
Anyone who will be vaccinated will produce the immune response in four to six weeks. The vaccine will not provide any immediate protection. If it will give protection in four to six weeks, or adequate protection only after the mandatory second dose. Then what is the meaning of emergency in this?
Regarding the corona warriors, the Union minister for health and family planning Dr Harsh Vardhan submitted on the floor of the parliament that the government has no data regarding the number of corona warriors who died during the pandemic despite the fact that most of such doctors, nurses, and other paramedical workers are part of the formal/institutionalised medical structure. Would the government then be interested in diligently recording adverse events following vaccination? Should I then be taking the vaccine when in the event of any eventuality I may not even be counted as a statistic?
(The author is an Assistant Professor. Centre of Social Medicine and Community Health, Jawaharlal Nehru University. He is also a National Executive Member of Progressive Medicos and Scientists Forum (PMSF), a group of socially-committed doctors and scientists. Views expressed are personal and do not reflect that of Outlook Magazine)
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