The study is titled “Long-Term Safety Analysis” bbv152 Coronavirus vaccine in adolescents and adults: findings from a 1-year prospective study in North India, which was published in the journal Drug Safety in May 2024, was retracted and deleted on September 24. The journal editor announced the retraction, saying that the article was being retracted “because they no longer have confidence in the conclusions stated in the article.” A number of researchers, doctors, ethicists, scientists and members of civil society wrote an open letter condemning the decision, saying it “will have a negative impact on researchers and is damaging to public trust in science and the institution of science “
Why did the journal editor lose confidence in the article’s findings?
According to the withdrawal notice, a post-publication review concluded that the reported adverse events The AESI were presented in a manner that may lead to ambiguity or misinterpretations regarding the relationship with the BBV152 vaccine, popularly known as Covaxin. The notice said that, given these findings, the editor and publisher, Springer Publishing Company, decided that the article “should be removed.” public health Field.” It added that the authors disagreed with the retraction. Incidentally, the published study had been approved by the journal’s editor and reviewed by two independent reviewers. It was reviewed after incorporating revisions suggested by peer reviewers and the editor. Questions to the editor about whether the post-publication review was shared with the authors in accordance with Committee on Publication Ethics (COPE) guidelines, and whether they had the opportunity to respond to concerns raised in the review. There was no response as to how the study actually affected public health, and the journal decided to retract and remove the article before the case was filed in court. Bharat Biotech India Limited (BBIL), the manufacturer of the vaccine, took action against the authors and the journal editor.
Why did the study cause controversy when it was published?
When the study was published, there was significant media coverage, with most headlines stating that one-third of study participants who received the vaccine reported adverse events. The paper also said that only 1% of participants developed severe AESI. However, AESIs are defined by WHO as pre-specified clinically significant events that are likely to be causally associated with a vaccine and require careful monitoring and confirmation by further specialized studies . Obviously, AESI after vaccination cannot be unequivocally said to be caused by the vaccine. There is only a possibility that they may be “reasonably associated” with the vaccine and this needs to be studied further. Many pointed out several flaws in the study’s design, while some felt that parts of the discussion in the paper could be misleading. The Indian Council of Medical Research (ICMR) reacted sharply to the uproar created in the media regarding this.), which, within days of the study’s publication, sent a letter to the journal editor and authors raising several objections and demanding its retraction.
Why did ICMR want to withdraw the paper?
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 the acknowledgment being made “for research assistance”, stating that it was not associated with the study nor had it provided any financial or technical support for the research. The council said the acknowledgment was “without any prior approval or intimation to ICMR”, which was “inappropriate and unacceptable”. Although the authors explained why they had accredited ICMR, they later asked for all acknowledgments to be removed, as the journal objected to the fact that they did not have written permission from ICMR to accredit the institution. Incidentally, while ICMR had 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 only 176 participants (aged 15–18 years), In which telephonic interviews were used to collect adverse data. Events seven days after vaccination. ICMR in the letter also did not disclose its conflict of interest as a co-developer of the vaccine with BBIL, from which it earned about Rs 172 crore in royalties. A group of epidemiologists, doctors and public health experts criticized ICMR for “academic censorship” instead of addressing its shortcomings to advance studies and raise standards. vaccine safetyThe group urged ICMR to demand publication of the long-term follow-up of the phase-3 trials, which has not yet been published by Bharat Biotech.
Why did Bharat Biotech file a defamation case against the authors of the paper?
Bharat Biotech, in its petition, claimed without providing any evidence for this allegation that the research was done at the behest of its competitors. It claimed that “the study created shock, concern and hesitation in the public mind about the quality and efficacy of the vaccine”, even though covid vaccination The program ended long before the study was published in May 2024. Additionally, the study was on AESI, which is not necessarily related to any vaccine. This only emphasized the need for confirmation from future studies. The company claimed that the study had negatively impacted its business and that it had lost the contract to supply the vaccine due to the defamatory study. The company sought damages of Rs 5 crore for loss in business and defamation. However, exports of Covaxin were halted from April 2022 after WHO raised unspecified concerns about its manufacturing following an inspection of production facilities in Hyderabad. Due to lack of demand, the company had stopped production of Covaxin after the first quarter of 2023, much before the study was published. In their affidavit in the court, the authors pointed out that the company should have sent its objections to the journal and sought debate and discussion on the study’s methodology and findings within scientific forums instead of sending and filing their comments to the media. Case against him.
What objections were raised by researchers, doctors, ethicists, scientists and civil society members supporting the study authors?
The paper noted that, like most research studies, it had various limitations, which the authors acknowledged in the paper. The study showed that 99% of people did not have any serious events, which the government could have used to increase public confidence in the vaccine. The letter said ICMR should have set up a follow-up study to investigate the causal relationship between any 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 individuals, although the study could not make such a claim because it was designed to investigate a causal relationship between the two. Was not designed for. Vaccine and adverse events. “The action of ICMR and BBIL is short-sighted and punitive. Scientific disagreements should be expressed as counterpoints in scientific forums. The letter said that forcing the journal to withdraw the paper or filing a defamation suit of Rs 5 crore reflects badly on researchers and is detrimental to science and people’s trust in the institution of science. 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.
