It is a matter of pride for us that a person of Indian origin, presently Director of National Institute of Health, USA, is poised to take over one of the most powerful roles in public health. Professor Jay Bhattacharya, an Indian origin physician and a health economist, from Stanford University, USA, will be assuming the appointment of acting head of the Centre for Disease Control and Prevention (CDC), USA. Bhattacharya would be leading two apex institutions in the field of public health which not only shape American health policies but act as bellwether globally.
During the Covid-19 pandemic, Bhattacharya was a vocal critic of school closures and business shutdowns. He co-authored the Great Barrington Declaration in 2020 which recommended ending widespread lockdowns and instead advocating focused protection of the elderly and vulnerable individuals. For this, he received attracted criticisms from the medical community during the pandemic with the former NIH director Francis Collins dismissing him as a “fringe epidemiologist.” Others, however, rallied behind Bhattacharya, viewing him as a sane voice against draconian restrictions and vaccine mandates.
During the pandemic, India missed “the bus of sanity” even though it originated in the country!
It is ironical that persons of Indian origins have to be recognized first by the West, before being acknowledged in their country of origin. Born of Indian parents, Jay Bhattacharya was trained in medicine and economics at Stanford University, where he was a faculty before assuming the appointment of Director at NIH. Perhaps his Indian roots made him perceptive of the trials and tribulations faced by poor people consequent to the restrictive measures during the lockdown. And being a health economist he would also understand the cost-benefits of mass vaccination in a young population like India, besides the risk of harms from the vaccine AstraZeneca (Covishield in India). This vaccine was not licensed in the USA due to serious adverse effects during its trials. Covishield was not given to people below 40 years in European countries as clotting disorders due to it were found to be more among the young.
In view of these concerns, when the Covid-19 vaccine was being rolled out in India, Prof Jay Bhattacharya had advised restraint in rolling out mass vaccination for the Indian population stating that it would cause great harm and little benefit given the country’s demography and the fact that most had naturally acquired immunity due to widespread community transmission, which is more robust than vaccine induced immunity.
India ignored this sane advice from Jay Bhattacharya, apparently considering him a “fringe epidemiologist” as dubbed by the great actors on the scientific stage during the pandemic, viz Anthony Fauci and his disciples like Collins who was the Director of NIH during the pandemic.
Unfolding events increase concerns about the harms predicted by Bhattacharya
The first jolt was the admission by AstraZeneca in a UK court that their Covid-19 vector based vaccine, which is marketed as Covishield in India, could, in “rare” instances cause “thrombocytopenia thrombosis syndrome” or TTS. This causes platelets in the blood to clump and form clots which can block blood supplies to the heart (causing heart attacks) or the brain (leading to stroke). While the epicentre of this confession was the UK, the shocks were felt in distant India, where over 100 crores had received this vaccine.
While still coping with this disturbing news, a further aftershock was the announcement a few days later by AstraZeneca that it is recalling this vaccine. The news sparked panic on social media that their product was being withdrawn because of serious concerns about health risks. The manufacturer of the vaccine on the other hand reiterated that the withdrawal of their product was entirely due to commercial considerations because of steep decline of demand for this vaccine.
AstraZeneca vaccine was the parcel in the Covid pandemic party game
The vaccine was never approved in the USA. Was it due to mishaps during the AstraZeneca vaccine trials in this country? A volunteer in one of the vaccine trial centres in the USA, Brianne Dressen had an harrowing experience after taking the jab. A former rock climber, she was severely incapacitated after the jab. Her vision and hearing were distorted, she had severe heart rate fluctuations, severe muscle weakness, and she had a sensation of internal electric shocks. She had to spend most of her time in a darkened room, unable to brush her teeth, or tolerate the touch of her children. She also found other people who had never suffered from Covid-19 but experienced serious and long-lasting health problems after taking the coronavirus vaccine.
Researchers were non-communicative. Avindra Nath, the lead investigator, conceded that that her injury could be due to the vaccine, but fell short of accepting a “cause-effect” relationship. What dismayed the sufferers of these symptoms post-vaccination was the pullback by the investigators as communications with these patients dwindled by late 2021. One wonders whether such mishaps during the trials in the USA could be the reason for the AstraZeneca not being approved in the USA?
Other developed countries also cold shouldered the AstraZeneca vaccine developed by Oxford University in the UK, with Swedish collaboration. A peer reviewed paper in the journal Vaccines, established from real world data that the Odds of developing TTS or blood clots was 4 to 6 times more with the AstraZeneca vaccine compared to Pfizer vaccine and 4 to 10 times more compared to the Moderna vaccine. In March 2021, in response to spontaneous reports of blood clots among individuals who received the Oxford-AstraZeneca vaccine, several European countries halted the administration of this vaccine.
While such concerns were coming out during the trials in the USA and real world data emerging from the European continent, AstraZeneca entered into partnership with Serum Institute of India, Pune to scale up production of this vaccine, marketed as Covishield in India. The parcel was passed from USA to Europe which passed it on to India and the music stopped!
The Indian Irony – young with higher risk of blood clots and little risk from Covid-19 given the vaccine on a mass scale
Trials and real world data in the West had established that such serious events from the AstraZeneca were more common among the young. In response, the UK restricted its use in people below 40 years of early during the mass rollout before phasing it out completely. India, sadly, succumbed to the promotion of the vaccine.
India is the country of the youth. Around three-fourths of its population is below 40 years of age. A paper in the Journal of Medical Ethics states that administering Covid-19 vaccines to the young is not ethical as it may result in a net harm.
In a country of over 140 crores with around 75% of our population below 40 years as a ballpark estimate we have administered the Covishield vaccine to around 80 crores young Indians at least risk from the Covid-19 and at higher risk of adverse events. Early in the pandemic it was established that the infection fatality rate of the novel coronavirus was in the range of 0.00% to 0.05% among people below 70 years, tending towards zero among the youth. Moreover, by the time vaccine was rolled out among the young, serosurveys showed that over 80% of the young had recovered from natural infection adding to their already robust immunity.
The great Indian Irony is that our policy makers got it right early on. Dr N K Arora, Head, National Technical Advisory Group on Immunization wrote an opinion piece dated April 12, 2021, in the Times of India, titled, "Opening up vaccines for younger adults (18 to 45 years) right now will be a gamble with lives." However, they lost the way as political and commercial pressures piled up.
Andrew Bridgen an UK parliamentarian recently gave a statement in the British Parliament based on extensive research and study of scientific journals, He summarized the incidence of serious injuries from the covid-19 vaccines as around 1 in 800. So even on a conservative estimate if we take that 100 crores Indians were given the Covid-19 vaccine, around 1,250,000 of our citizens, 75% of them young, might have suffered from serious adverse events, including deaths, most of them going unnoticed and unreported.
With our poor system of Adverse Events Following Immunization (AEFI reporting), we are unable to capture even a fraction of the adverse events. According to a peer reviewed paper we are able to report only 1% of the deaths due to the Covid-19 jabs.
The safety of the Covid-19 vaccines was promoted with such force that even leading experts in vaccine science have difficulty in reporting vaccine injury, as reported by New York Times. Dr Gregory Poland, 68, Editor-in-Chief of the journal, Vaccine, said that a loud whooshing sound in his ears had accompanied every moment since his first shot, but that his entreaties to colleagues at the Center for Disease Control and Prevention to explore the phenomenon, tinnitus, has led nowhere. He received polite responses to his many emails, but “I just don’t get any sense of movement,” he said. “If they have done studies, those studies should be published,” Dr Poland added. In despair that he might “never hear silence again,” he has sought solace in meditation and his religious faith!
If this is the ordeal of a vaccine injured Editor of a leading Medical Journal on the subject, in a developed country with better reporting of adverse events, one can only imagine the fate of those who have suffered or died from the vaccine in our country.
In spite of overwhelming evidence on the contrary, our experts continue to parrot that while adverse events including deaths are rare, the benefits of the vaccine outweigh the miniscule risk. They support this claim based on mathematical model studies sponsored by the Gates Foundation among others with serious conflicts of interest. On the other hand real world studies show no correlation between vaccination coverage and incidence of Covid-19, while data in public domain show rise in cases as well as deaths from Covid-19 after the introduction of mass vaccination. For illustration the cases and deaths before and after mass vaccination are illustrated below for Israel and Singapore. Similar phenomenon has been observed in Australia, Sri Lanka, Japan, USA, UK, Indonesia, Malaysia, and many other countries. A presentation on this paradox was made on 01 March 2024, in a session hosted by AIIMS New Delhi with a request to send counterview supported by data. No rebuttal has been received yet. I leave it to the reader to decide whether the risk from the Covid jab outweighs the risks.
Clumsy attempts in damage control by ICMR by hastily assembled flawed studies
A study published in the Indian Journal of Medical Research has ruled out any association between the Covid-19 vaccines and sudden cardiac deaths. On first glance the paper looks quite impressive if not intimidating, with over 100 authors spread over 47 tertiary care hospitals. Almost all the premier institutes in the country are involved in this research as well as many private medical colleges. A large number of ICMR researchers also took part in the study; in fact the media headlines refer to this as an ICMR study.
The study with so many heavyweight researchers from premier institutions in the country and with the stamp of authority of the country’s apex medical research body, the ICMR, must be quite reassuring to Indians as the majority of us have taken the covid jabs. To criticize such a study would perhaps be blasphemy.
But taking a lead from Einstein, I cannot restrain myself from conveying the “uneasy feeling” I experienced after reading the paper. In response to the book, “A Hundred Authors against Einstein,” he had stated that if he were wrong, then one author would have been enough.
I am no Einstein by any stretch of imagination. And instead of one author being challenged, I am raising some concerns about the work of a hundred authors. I know I may be considered highly presumptuous. But risking this, I offer some questions around the study. The journal which published this ICMR study was sporting enough to publish my critique , enough to render the study null and void. More flaws in the ICMR study was pointed out by a data scientist from IIT Bombay; this communication was also published.
After reading the original study by ICMR and its critiques, the reader can decide how much reassurance is offered by the study conducted by our premier research body.
Countries with good data, alas India does not fall in this category, are showing disturbing trends of all cause mortality and sudden deaths, particularly of young people. This is the person distribution. That these deaths are showing rising trends following mass Covid-19 vaccine rollouts is the time distribution. The place distribution is almost global particularly in places with high vaccine coverage. Of particular interest is the phenomenon in Australia. The Australian data is not reassuring. Australia, due to its stringent measures, almost had no Covid-19 outbreak.
A very recent study published in mainstream journal, “International Journal of Risk and Safety in Medicine,” has raised strong evidence about the link between Covid-19 mass vaccination and all causes excess mortality and health events in the Australian population. The paper concluded that combined with increasing evidence that the efficacy/effectiveness and safety of COVID-19 vaccines have been greatly exaggerated, including acknowledgements from the Australian and American governments that several deaths have been caused by the vaccines, these findings make it a near-certainty that COVID-19 vaccines have been – and continue to be – contributing to excess mortality.
The way forward
Science should be objective and should not get polarized like politics or swayed by commercial interests. The ICMR has entered into various collaborations and agreements with various organizations having commercial interests and such liaisons disqualify them from investigating into vaccine harms.
No wonder, the ICMR tried to intimidate researchers from the prestigious Banaras Hindu University (BHU) investigating adverse effects of the Covaxin and got their paper retracted by threat of legal action. For this they drew flak from Universal Health Organization (UHO), an independent public health watchdog.
Members of the UHO, based on meticulously analysed data, also drew attention to the rise in sudden deaths, way back in December 2022, and recommended a thorough investigation and well matched follow up study of the vaccinated vis-à-vis the unvaccinated to get the correct picture. But yet, such a basic study needs to be undertaken.
We need an independent body to monitor the safety and efficacy of the Covid-19 vaccines and other newly emerging vaccines as well as vaccines in use. Our Adverse Events Following Immunization (AEFI) system also needs to be beefed up. We should explore the use of emerging technologies like Artificial Intelligence with full transparency for monitoring of adverse events following vaccination with full access for public reporting and follow up investigations including post-mortem studies where relevant by independent researchers without any conflicts of interests.
Unless these robust measures are in place, public trust, which has been badly shattered due to reports of adverse events from interventions, real or rumored, during the pandemic, cannot be restored.
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*Dr Amitav Banerjee, a renowned epidemiologist, is currently Professor Emeritus at Dr DY Patil Medical College. Pune, India. He is included in Stanford University’s list of top 2% scientists globally for three consecutive years. He is the Founder Chairperson of Universal Health Organization, a registered watchdog on public health issues (https://uho.org.in/). He has authored the book, Covid-19 Pandemic: A Third Eye
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