Skip to main content

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


Maya Valecha said…
Dr Guleria is not just a clinician. He was the Director of AIIMS, Delhi, a premier institution that conducts many studies for intervention in public health policies. he himself appeared on TV during pandemic to advise about pandemic. He cannot be forgiven for such irresponsible, misleading statement.

An Indian study and statistics would have helped because it is known that different races react differently to drugs and vaccines.


IMA vs Ramdev: Why what's good or bad for goose should be good or bad for gander

By Dr Amitav Banerjee, MD* Baba Ramdev and his associate Balkrishna faced the wrath of the Supreme Court for their propaganda about their Ayurvedic products and belittling mainstream medicine. Baba Ramdev had to apologize in court. His apology was not accepted and he may face the contempt of court with harsher punishment. The Supreme Court acted on a public interest litigation (PIL) moved by the Indian Medical Association (IMA).

Women innovators on simple, revolutionary alternate solutions for water problems

By Proshakha Maitra, Mansee Bal Bhargava* The detrimental effects of uncontrolled population rise and accelerated change in the global climate have posed tremendous pressure on the water and sanitation. This calls all stakeholders, from both developed and developing nations, to improve their resilience and to instigate sustainability. It is more crucial than ever to optimise the use of the resources we have on hand since the world population is projected to reach 9.7 billion by 2050.

Magnetic, stunning, Protima Bedi 'exposed' malice of sexual repression in society

By Harsh Thakor*  Protima Bedi was born to a baniya businessman and a Bengali mother as Protima Gupta in Delhi in 1949. Her father was a small-time trader, who was thrown out of his family for marrying a dark Bengali women. The theme of her early life was to rebel against traditional bondage. It was extraordinary how Protima underwent a metamorphosis from a conventional convent-educated girl into a freak. On October 12th was her 75th birthday; earlier this year, on August 18th it was her 25th death anniversary.

Alleged killing of another Bangladesh youth inside Indian territory: NHRC inquiry sought

By Kirity Roy* There was yet another incident of the killing of a Bangladeshi youth by the Border Security Force personnel attached with ‘Barthar’ BOP of ‘G’ Company of 75 BSF Battalion. In last five years several incidents of killings happened under this police station’s jurisdiction and the cases will get the award as “Not Guilty” as usual.

Modi model, Hindutva icon 'justified' alliance with Muslim League before Independence

By Shamsul Islam*  Our PM describes himself as ‘Hindu’ nationalist and member of RSS. He proudly shares the fact that he was groomed to be a political leader by one of the two fathers of the Hindutva politics, MS Golwalkar (the other being VD Savarkar) and given the task of establishing Hindutva polity in India after eradicating secularism.

A Hindu alternative to Valentine's Day? 'Shiv-Parvati was first love marriage in Universe'

By Rajiv Shah*   The other day, I was searching on Google a quote on Maha Shivratri which I wanted to send to someone, a confirmed Shiv Bhakt, quite close to me -- with an underlying message to act positively instead of being negative. On top of the search, I chanced upon an article in, imagine!, a Nashik Corporation site which offered me something very unusual. 

Crusader for people’s causes, this Hollywood actor entered 'unexplored zones' in US

By Harsh Thakor*  Marlon Brando on April 3rd completes his birth centenary. He perished in 2004, on July 1, aged 80 years. Arguably in Hollywood Brando penetrated sensitivity and versatility at an unparalleled scale and discovered new horizons or explored path breaking zones in acting.

Nuclear power expansion: Is AEC's new, 'unrealistic' target fully backed by PMO?

By Shankar Sharma*  Another unrealistic and tall claim by Atomic Energy Commission (AEC) has been announced: India is eyeing 100 GW nuclear power by 2047, the AEC chairman  AK Mohanty   has said. A few years ago, the dream target for the Indian nuclear establishment was 275,000 MWe of nuclear power by 2050 (as per DAE document of 2008 "A Strategy for the Growth of Electricity in India”). Now this target of 100 GW nuclear power by 2047. And as at the end of February 2024, the actual nuclear power capacity was only 7,480 MWe, which formed only 1.7% of the total power capacity in the country. 

How huge crowd at Mukhtar Ansari funeral is comparable to BJP's 'people's court' talk

By Vidya Bhushan Rawat*  The massive crowd at the funeral of Mukhtar Ansari in Mohammadabad reflects the power and influence that his family wields in the area. One can't deny that he had enormous power in Ghazipur and Mau districts. But the crowd that came and chanted slogans in his favour does not exonerate him of his conviction by the court.  It is important that we understand this. 

'Critical for cultural and ecological security': Ladakh women seek statehood, self-rule

By Our Representative Six Ladakhi women from different organisations in the region, who concluded their 10 day fast, have told an online press conference that it is necessary to provide statehood to Ladakh, even as declaring the region under the 6th schedule, for “deepening democracy, preserving ecology, and for survival.” Feminists across India joined the media meet in solidarity with the Ladakh movement “for 6th schedule, statehood and justice.”