The 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findings from a 1-year prospective study in north India,” which was published in May 2024 in the journal Drug Safety, was retracted and removed on September 24. Announcing the retraction, the journal editor stated that the article was being retracted “as he no longer has confidence in the conclusions as stated in the article.” Several researchers, doctors, ethicists, scientists, and civil society members wrote an open letter condemning this decision, saying it would have “a chilling effect on researchers and is harmful to science and the trust people have in the institution of science.”
Why did the journal editor lose confidence in the conclusions of the article?
According to the retraction notice, a post-publication review concluded that the reported adverse events of special interest (AESIs) were presented in a way that could lead to ambiguous or incorrect interpretations regarding the relationship with the BBV152 vaccine, popularly known as Covaxin.The notice added that, given these findings, the editor and the publisher, Springer Publishing Company, decided that the article “should be removed on public health grounds.” It stated that the authors disagreed with the retraction. Incidentally, the published study had been cleared by the journal’s editor and peer-reviewed by two independent reviewers. It had been published after incorporating the revisions suggested by the peer reviewers and the editor. Questions to the editor about whether the post-publication review had been shared with the authors, as mandated by the Committee on Publication Ethics (COPE) guidelines, and whether they were given a chance to respond to the concerns raised in the review, went unanswered. There was also no response on how exactly public health was affected by the study. The journal decided to retract and remove the article even before a decision was made on the court case filed by Bharat Biotech India Ltd. (BBIL), the manufacturers of the vaccine, against the authors and the journal editor.
Why did the study create controversy when it was published?
When the study was published, there was significant media coverage, with most headlines stating that one-third of the study participants who took the vaccine reported adverse events. The paper also stated that only 1% of participants developed serious AESIs. However, AESIs are defined by the WHO as pre-specified medically significant events that have the potential to be causally associated with a vaccine and need to be carefully monitored and confirmed by further special studies. Clearly, AESIs after vaccination cannot be categorically said to be caused by the vaccine. There is only a probability that they could be “causally associated” with the vaccine and need to be studied further. Many pointed out several flaws in the study design, while some felt that parts of the discussion in the paper could be misleading. The media frenzy around it drew a sharp reaction from the Indian Council of Medical Research (ICMR), which, within a few days of the study’s publication, sent a letter to the journal editor and the authors, raising several objections and seeking its retraction.
Why did ICMR want the paper retracted?
Most of the objections to the study, including those raised by ICMR, were already recorded and explained by the authors in the limitations section of the study. ICMR strongly objected to being acknowledged “for research support,” stating that it was not associated with the study nor had it provided any financial or technical support for the research. The council added that the acknowledgment was “without any prior approval or intimation to ICMR,” which was “inappropriate and unacceptable.” Although the authors explained why they had acknowledged ICMR, they subsequently asked for all acknowledgments to be removed, as the journal objected to the fact that they did not have written permission from ICMR to acknowledge the institution. Incidentally, while ICMR objected to the use of telephonic interviews for data collection in the study, it did not mention that BBIL had also conducted a safety study with just 176 participants (aged 15-18 years), using telephonic interviews to collect data on adverse events seven days after vaccination. ICMR also did not disclose in the letter its own conflict of interest as a co-developer of the vaccine with BBIL, from which it earned about Rs 172 crore in royalty. A group of epidemiologists, doctors, and public health experts criticized ICMR for “academic censorship” instead of building on the study and addressing its shortcomings to elevate the standards of vaccine safety. The group urged ICMR to seek publication of the long-term follow-up of phase-3 trials, which is yet to be published by Bharat Biotech.
Why did Bharat Biotech file a defamation case against the authors of the paper?
Bharat Biotech claimed in its petition that the research was conducted at the instance of its competitors, without providing any proof for this allegation. It claimed that “the study created shock, alarm, and hesitancy in the minds of the public regarding the quality and efficacy” of the vaccine, even though the Covid vaccination program had ended long before the study was published in May 2024. Moreover, the study was on AESIs, which are not necessarily causally related to a vaccine. It only emphasized the need for confirmation from future studies. The company claimed that the study had negatively affected its business and that it had lost out on contracts for the supply of the vaccine because of the defamatory study. The company sought Rs 5 crore in damages for loss of business and defamation. However, the export of Covaxin had been halted since April 2022 after the WHO raised unspecified concerns about its manufacturing following an inspection of the production facilities in Hyderabad. The company stopped producing Covaxin after the first quarter of 2023, long before the study was published, due to a lack of demand. In their affidavit in court, the authors pointed out that the company ought to have sent its objections to the journal and sought a debate and discussion on the methodology and findings of the study within scientific forums instead of sending their comments to the media and filing a case against them.
What were the objections raised by researchers, doctors, ethicists, scientists, and civil society members supporting the study authors?
The letter pointed out that, like most research studies, this one had various limitations, which the authors had acknowledged in the paper. The study showed that 99% of people did not have any serious events, which could have been used by the government to bolster people’s trust in the vaccine. The letter added that ICMR ought to have set up follow-up studies to examine the causal relationship between any reported adverse events and the vaccine. According to the letter, several media reports misinterpreted the study, suggesting that the vaccine caused side effects in one-third of the individuals, even though no such claims could be made from the study because it was not designed to examine a causal link between the vaccine and the adverse events. “The actions of ICMR and BBIL are short-sighted and punitive. Scientific disagreements have to be articulated as counterpoints in scientific fora. Forcing the journal to retract the paper or filing a Rs 5 crore defamation suit leads to a chilling effect on researchers and is harmful to science and the trust people have in the institution of science,” the letter stated. It called for “a mature, open-minded, and more confident response” from ICMR and demanded that the lawsuit be withdrawn and the paper reinstated in the journal.