On 24th September, the journal Drug Safety retracted a paper it had published in May 2024 regarding the safety of Covaxin, a homegrown COVID-19 vaccine made by Bharat Biotech. The note on Springer about the retraction of the article reads, “The Editor has retracted this article as he no longer has confidence in the conclusions as stated in the article. 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. Given these findings, the editor and the publisher have decided that this article should be removed on public health grounds.”
The authors, however, disagreed with the retraction. The retraction came almost two weeks after Bharat Biotech sued eleven BHU researchers who authored the paper along with Drug Safety, the journal of the International Society of Pharmacovigilance.
Journal’s editor, Nitin Joshi, who is based in Auckland, New Zealand, informed the authors about the journal’s intent to retract the paper on 28th August. Replying to him, one of the co-authors wrote, “This unilateral decision of yours to retract the paper not only risks defaming the authors but also sets a troubling precedent where academic journals may appear submissive to external pressures, including those imposed by industry and others.”
The retraction came almost two weeks after Bharat Biotech sued eleven BHU researchers who authored the paper along with the journal Drug Safety. The case was filed in the City Civil Court, Hyderabad. In its suit, Bharat Biotech International Limited (BBIL) alleged that the claims made by the researchers and the journal created “shock, alarm and hesitancy” among the public over the efficacy of Covaxin and the company’s other products.
The company further stated that the study was “defamatory” and sought a permanent injunction against the research paper. The company sued the researchers involved in the study for Rs 5 crore in damages along with interest.
The petition, accessed by Times of India, noted that BBIL termed the study as poorly designed with a flawed methodology. It also noted that the statements made by the researchers had “irreversibly damaged” the reputation of the company, its products, and commercial interests.
BBIL urged the court to pass orders to take down the study and issue a permanent injunction to restrain the researchers from further publishing defamatory and flawed studies on Covaxin and BBIL.
Responding to the case filed against them, BHU researchers denied the allegations and termed the petition as an instance of a SLAPP (strategic lawsuits against public participation). They claimed the sole objective of the petition was to muffle or stifle any type of criticism or research about the vaccine.
‘Incorrect, misleading and unacceptable’ – How ICMR reacted to flawed study by BHU researchers
On 20th May, the Indian Council of Medical Research (ICMR) strongly refuted the ‘study’ done by researchers at Banaras Hindu University (BHU) where it was suggested that over 30% of the people who received the made-in-India COVID-19 vaccine, Covaxin, experienced side effects. In its statement, ICMR not only labelled the study as “incorrect, misleading and unacceptable” but also demanded that it should be retracted by the publisher, Springer.
Flawed study raises concerns
The study titled “Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from One Year Prospective Study in North India” stirred controversy as it reported several adverse effects from the vaccine. The side effects included nervous system disorders, skin disorders, menstrual abnormalities and hypothyroidism. The study was conducted by Dr Upinder Kaur and Dr Sankha Shubhra Chakrabarti of BHU. The sample size of the study was 1,024 Covaxin recipients and the information about the possible side effects was collected via telephonic conversation a year after the vaccination.
Methodological issues highlighted
ICMR, in its statement, pointed out that there were several methodological flaws in the study. For example, there was no control group of unvaccinated individuals which made it impossible to conclude that the side effects occurred due to the vaccination. Furthermore, the study did not provide any baseline information and background rates of observed events. Such information is crucial for assessing any changes in incidents after the vaccination was taken by the recipients.
Bharat Biotech defends Covaxin
The manufacturer of Covaxin, Hyderabad-based Bharat Biotech, responded to the controversy and defended Covaxin. The company stressed that the study done on the vaccine should consider a broad range of data to avoid any bias. The company further added that the researchers should compare the data of vaccinated and non-vaccinated individuals to get accurate results. Bharat Biotech highlighted that multiple peer-reviewed studies have confirmed Covaxin’s excellent safety profile.
The company said, “For such a study in safety to be effective, informative and to avoid investigator bias, the following data points are also required: AESI safety profile of the subjects before participation in the study; Comparison of safety profile of non-vaccinated subjects during the study; comparison of safety profile of subjects who received other vaccines during the study; all study participants should be followed during the study, instead of only a subset; several studies have been executed on the safety of COVAXIN, and published in peer-reviewed journals, demonstrating an excellent safety track record.”
