Journal ‘retracts’ BHU’s controversial paper on Covaxin safety

File image.
| Photo Credit: SHIV KUMAR PUSHPAKAR

The journal ‘Drug Safety’ has retracted a paper published on May 13 by researchers of the Banaras Hindu University, on the safety of COVID-19 vaccine Covaxin.

The paper, “Long-term safety analysis of the BBV152 coronavirus vaccine in adolescents and adults: Findings from a 1-year prospective study in North India”, was based on a follow up of 635 adolescents and 291 adults one year after vaccination, to find the safety of Covaxin. It was a prospective observational study conducted from January 2022 to August 2023 where the recipients of the vaccine were interviewed over the telephone about the long-term adverse events of special interest (AESIs) one year after vaccination.

Also read | The right way to counter a poor Covaxin safety study 

The retraction notice put up on Tuesday 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.”

While criticising the authors for the “poorly designed” study, the Indian Council of Medical Research (ICMR) on May 18 wrote to the editor to retract the paper that “implicitly makes conclusions about the vaccine safety that are not supported by evidence”. But the paper was not retracted as demanded by the ICMR. Besides criticising the study for its limitations, Bharat Biotech also filed a defamation case against the authors and the editor of the journal. In the prayer of the defamation notice, Bharat Biotech wanted the journal to take down the “defamatory research study” and a “permanent injunction” against the authors and the editor from “further publishing defamatory and flawed studies” on Covaxin. Bharat Biotech also wanted ₹5 crore for the “loss and injury caused by the defamatory research study”.

Contrary to the claim by the journal that the paper has been retracted — where the original paper is still available on the journal website with a retracted watermark appearing on each page of the paper, the original paper has been removed from the website with only the “retraction” notice mentioning the reasons available. “That the paper has been removed from the website instead of a retraction watermark being added to the original paper suggests that the removal of the paper was due to the defamation case and not due to scientific reasons as the notice mentions,” Amar Jesani, editor of the Indian Journal of Medical Ethics told The Hindu. “The journal has thrown the authors under the bus.”

In an open letter written to Bharat Biotech and the Director-General of ICMR, over 600 scientists, researchers, ethicists, doctors, patients, and civil society members had said that the defamation suit will lead to a “chilling effect on researchers, and is harmful for science and the trust people have on the institution of science”. The open letter further adds: “In our view, the actions of ICMR and BBIL are short-sighted and punitive. Scientific disagreements have to be articulated as counterpoints in scientific fora.”