The controversial study on the Covaxin vaccine, published by a team of researchers at the Banaras Hindu University (BHU) has been retracted by its journal, Springer Nature’s Drug Safety yesterday, September 26, over a “lack of confidence” in the conclusions drawn in the article.
This study, titled Long-Term Safety Analysis of the BBV152 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India, was published on May 13.
Following its publication, several news reports on the study claimed that it showed one-third of the participants of the research suffered from side effects within a year after getting the vaccine and that some of them even went through Adverse Effects of Special Interest like stroke and Guillian-Barre Syndrome.
In response, the Indian Council of Medical Research (ICMR) criticised the study on May 28, questioning the research methodology of the study and demanding that the paper be retracted. Soon enough, on September 13, Bharat Biotech International filed a defamation suit of Rs 5 crore on the research team.
It must be noted that ICMR and Bharat Biotech produced Covaxin jointly.
Responding to the lawsuit, a group of researchers, scientists, doctors, and civil society members issued an open letter to Bharat Biotech on September 23, expressing their shock at its “short-sighted and punitive” response to the research paper.
Defamation suit detrimental to research, scientists say
According to the authors of the letter, slamming a Rs 5 crore defamation suit on the scientists behind the research and forcing their paper to be retracted creates a “chilling effect” on researchers.
“Such lawsuits would make doctors think twice before conducting research studies,” says Dr Veena Shatrugna, a nutritionist and retired scientist at the National Institute of Nutrition, who is also one of the signatories of the letter.
She adds, “Medical research in India is already very scarce, and doctors rely on studies conducted by Western doctors — which may not be completely compatible with Indian bodies. This lawsuit sets a bad precedent in the independent research from doctors.”
Moreover, the reactions by ICMR and Bharat Biotech are also harmful to the trust people have in the institution of science, the letter argues.
Elaborating more on this, Dr Akshay S Dinesh, a public health researcher and one of the signatories of the letter, says that this defamation suit only increases vaccine hesitancy — an already serious challenge to public health in India.
He says that most of the time, vaccine hesitancy stems from a deep mistrust in the government.
“During the COVID-19 pandemic, the Government of India tried to accelerate the production of the vaccine drug, so that the first batch of the vaccines could start from August 15, which is our Independence Day. As a result, when the vaccine becomes a tool to score political points, it is obvious that people would hesitate to get the vaccine, as they deem their bodily integrity more important than political points,” he explains.
Moreover, with superstition, fake news, misinformation and pseudoscience running rampant in India due to a lack of scientific literacy, such responses to a study on the health conditions of those who were administered the vaccination by their manufacturers only add to the mistrust, and creates an environment of panic among the people, he says.
“Forcing the study to be retracted and pressing defamation charges on its authors can be seen as ICMR and Bharat Biotech imposing their power to shut down alternate viewpoints, criticisms or possibilities around the vaccine — especially when the study got the relevant ethics clearances, and does not contain malpractice,” he adds.
Both Dr Dinesh and Dr Shatrugna opine that contestations in scientific studies must be countered through more research.
“The question is not about the study, the robustness of its methodology, or its findings — rather, it is about the interpretation of said findings. Ideally, ICMR should have come out with new interpretations of the study or demonstrated why it disagrees with its findings. It should have taken this opportunity to ignite a discussion on the study’s merits and demerits, and arrive at a common consensus,” he explains.
Adding to this, Dr Shatrugna says that such deliberations and reviews are important traditions in the act of knowledge production, and must be encouraged. Instead, through this episode, the “whole terrain of scientific research has landed in the court of law,” she laments.
The open letter
In the letter, the authors express their dismay with the lawsuit and worry about the events that may transpire in the scientific community as a result.
Defending the research methodology employed in the study, the letter says that the study, similar to other research papers, has its flaws, which the authors of the study acknowledge. “It is common in science for starting from broad, simple studies and drawing on the results of these to go into more targeted and directed studies,” the letter states.
Terming it a “bare minimum” to document what happened to people who have taken the COVID-19 vaccine after it was universally rolled out, the letter mentions a Supreme Court verdict asking for the collection of data about adverse events, “even if they are not already known to be caused by the vaccine.”
According to a report by The Hindu, Bharat Biotech and ICMR are yet to publish the long-term safety data of the Covaxin phase-3 trial three years after the interim data was published.
Further, the letter also defends the integrity of the research, claiming it was only conducted following the approval from the Institutional Ethics Committee at BHU.
“The results were published in Drug Safety, the official journal of the International Society of Pharmacovigilance after a peer review process required and facilitated by the journal itself,” the letter said.
Unlike what was reported in the media, the study itself showed that 99 per cent of the respondents did not show any serious health problems, and the Government of India and ICMR should have used this opportunity to “bolster people’s trust in vaccine science,” the letter says.
“They (Government of India and ICMR) could have reassured the public about how low the rate of serious events after vaccination were, even if they are later discovered to be caused by the vaccine,” it adds.
The letter goes on to say that the media coverage of the study made ICMR and Bharat Biotech act defensively, with the former distancing itself from the paper and calling for its retraction, and the latter slamming the authors with a Rs 5 crore defamation suit. This was despite there being no link established between the vaccine and adverse events faced by the respondents in the study.
Expressing solidarity with the researchers, the letter thus states, “We demand for the lawsuit to be withdrawn, for the paper to be reinstated in the journal, and for constructive engagement from all stakeholders,” and calls for a more “mature, open-minded, and confident response” from organisations like ICMR.
