Covid vaccine: Want of evidence of adverse reaction 'shouldn't mean' absence of proof

Dr Randeep Guleria

By Dr Amitav Banerjee, MD* 
On 19 August 2023, the former director of the All India Institute Of Medical Sciences (AIIMS), New Delhi, Dr Randeep Guleria, issued a rather irresponsible statement saying that there is no evidence linking vaccines to serious health issues such as blood clots or heart attacks. As an epidemiologist with over four decades of experience, my reaction was biblical with this thought, “Father, forgive them, for they do not know what they are doing.” Let me explain.
The fascinating discipline of public health can be compared to the game of chess. Public health is the chessboard, various factors which affect the health of the people are the chess pieces and the rules of the game are the principles of epidemiology. Both the practice of public health and the game of chess call for abstract thinking.
To tackle public health problems a holistic epidemiological view is necessary. Few doctors choose this unglamorous and abstract discipline. As doctors, we all start with clinical medicine and the majority continue in this stream. Even during the pandemic, eminent clinicians were sought for their views being well known public figures.
The transformation from clinical medicine to epidemiology is akin to a chess player evolving to grandmaster’s level. In pandemics clinicians and epidemiologists will have different perspectives. Clinicians contributed immensely in the crises, some lost their lives. As a result, treatment regimes got refined, and case fatality came down considerably. 

However, they are not ideally positioned to see the dynamics of pandemics in the population. And post-pandemic, they are again not ideally placed to see the short and long term effects of the interventions. Seeing only one piece at a time, they are unable to see the whole chessboard.
However, one would have thought that experience might have made them wiser. Restrictive measures like lockdowns increased transmission in our country instead of preventing it due to our crowded housing conditions. To add insult to injury many hawkers and small time traders who conducted businesses in the open lost their livelihoods as they were pushed indoors by the police “danda.”
What is done cannot be undone. No point crying over spilt milk. But one should learn from past mistakes. “Experts” should substantiate their statements and not give opinions through their hats. These can mislead. At stake are human lives.
Dr Guleria categorically stated that there is no data or research that proves Covid vaccines could cause major changes in the body. “We have to first consider this: there is no vaccine or medicine that will have zero side effects. Every medicine or a vaccine will have some side effects. But there’s no concrete data that says heart attacks are caused by vaccines or sudden deaths are caused by vaccines,” he said.
Vaccines are given to healthy people while medicines are given to sick people. Howsoever rare even one death in a healthy person is one too many. Data and research from different countries are disconcerting. They are in the public domain. Let us hope Dr Guleria is unaware of them for then we can forgive him for he knows not what he does.
Western Australian Vaccine Safety Surveillance Annual Report 2021 shows a dramatic rise in AEFI following mass roll out of the Covid-19 vaccines in February 2021. The rates of AEFI following Covid-19 vaccines were almost 24 times higher compared to other vaccines. While AEFI following non-Covid-19 vaccines occurred in 11.1/100,000 doses administered, in case of Covid-19 vaccines AEFI occurred in 264.1/100,000 doses. This by no stretch of imagination can be called acceptable.
The rate of AEFI was highest for Astrazeneca (Covishield) at 306/100,000 doses. This is of particular relevance for India where Covishield was the main vaccine administered. Due to our poor vaccine adverse events reporting system we do not have similar figures for our country. 

This absence of evidence will tend to be taken as evidence of absence of AEFI. Perhaps this might be the reason why use of Astrazeneca/Covishield was suspended in many European countries which had better reporting systems for AEFI.

According to Australian data, Astrazeneca had the highest rate of adverse events at 306/100,000 (3 in 1000 doses administered)

Another misleading statement made by Dr Guleria was, “In many countries, as soon as there were doubts about a vaccine, the governments paused distribution for a while and then re-started it once there was enough study to prove it was safe for the body. There could be some side-effects of the vaccines but nothing claims lives.”

In fact many European countries have suspended and did not resume using the Astrazeneca (Covishield) vaccine over reports of blood clotting among the recipients. Eminent British Cardiologist, Dr Aseem Malhotra, during his visit to India, said that the Astrazeneca or Covishield vaccine, the main vaccine used in India, was even worse in terms of "cardiovascular events" compared to the mRNA vaccines. 

 “A comparison done up till June 2021, and published in a peer-reviewed research journal, showed that the Oxford/AstraZeneca's Covid vaccine is far worse than Pfizer's mRNA jab in terms of cardiovascular effects, heart attacks, strokes, some death and clotting problem in both younger and older adults,” according to Dr Malhotra.
Dr Guleria is a clinician. He may be forgiven if he misses the big picture. According to Australian data, Astrazeneca had the highest rate of adverse events at 306/100,000 (3 in 1000 doses administered). A clinician does not follow up 1000 cases, even if one does, the three scattered among the 1000 will be passed off as coincidental. But the patterns at the global level, i.e. seeing the whole chessboard, are disturbing. 

An op-ed on these patterns based on hard data calls for investigation of reports of otherwise healthy people suddenly collapsing and dying to determine if there is any correlation with vaccines or something else.
We have a poor Adverse Events Following Immunization (AEFI) reporting system. Even in developed countries only 2% of AEFI are reported. We should go for serious investigations and not wish away uncomfortable truths. Absence of evidence of adverse events due to poor AEFI should not be taken as evidence of absence. 

Our advisers, present and past, to the government should maintain a scientific temper instead of being opinionated and ostrich like in face of disturbing patterns of sudden deaths globally. When science is suppressed due to various conflicts of interest, people die.
---
*Professor in a Medical College in Pune. Earlier served in the Indian Armed Forces as a field epidemiologist; currently chairperson, Institutional Ethical Committee, National Institute of Virology, Pune (ICMR), and chairperson, Institutional Ethical Committee, Armed Forces Medical College, Pune; formerly chairperson, Institutional Ethical Committee, Chellaram Diabetic Institute, Pune