The retraction has sparked widespread debate, with critics accusing the journal of yielding to legal pressure rather than scientific reasoning.
Published Sep 27, 2024 | 6:37 PM ⚊ Updated Sep 27, 2024 | 6:37 PM
Journal retracts controversial BHU Covaxin study. (Wikimedia)
The Drug Safety Journal has retracted a study conducted by researchers from Banaras Hindu University (BHU) on the post-marketing safety of Covaxin, India’s first homegrown Covid-19 vaccine.
The retraction has sparked widespread debate, with critics accusing the journal of yielding to legal pressure rather than scientific reasoning.
In its retraction notice, Drug Safety stated it no longer had confidence in the study’s conclusions, citing concerns that the presentation of adverse events could lead to “ambiguous or incorrect interpretations” of Covaxin’s safety.
“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 disagree with this retraction,” said the Journal.
The study involved 635 adolescents and 291 adults who received Covaxin, among whom, nearly one-third reported experiencing adverse events of special interest (AESIs), including viral upper respiratory tract infections, menstrual abnormalities, and Guillain-Barre Syndrome.
While no direct causal link was established, the authors recommended further investigation into the potential long-term effects of the vaccine, particularly among adolescents and those with comorbidities.
Shortly after publication, the Indian Council of Medical Research (ICMR), which co-developed Covaxin with Bharat Biotech International Limited (BBIL), distanced itself from the study.
ICMR, which has received substantial royalties from Covaxin sales, criticized the study for lacking scientific rigour, pointing to the absence of a control group and high potential for bias.
The council requested the study’s retraction and demanded the authors remove any acknowledgement of ICMR’s involvement, threatening legal action.
Bharat Biotech, the manufacturer of Covaxin, filed a defamation lawsuit in Hyderabad against the authors and the journal’s editor, accusing them of publishing a “poorly designed” study with “flawed methodology.”
The company sought ₹5 crore in damages, claiming the study’s findings had tarnished its reputation and unfairly favoured competitor vaccines.
Bharat Biotech insisted that Covaxin’s safety record has been proven in multiple studies, and the defamation suit was necessary to protect the company from further harm.
In response, the BHU researchers denied any malicious intent, emphasising that their study was conducted in the interest of scientific inquiry.
They criticised Bharat Biotech for resorting to legal action instead of addressing concerns through scientific discourse, such as publishing a letter to the editor.
The controversy has led to an outcry from the scientific community, with over 600 scientists, doctors, and researchers signing an open letter calling for the lawsuit’s withdrawal.
The letter warned that the defamation suit could have a chilling effect on future scientific research and undermine public trust in the scientific process.
The retraction and the subsequent legal battle raised concerns about the ability to freely investigate and discuss vaccine safety.
Critics argue that the case underscores the importance of transparency and academic freedom, particularly in the assessment of vaccines, which play a critical role in global public health efforts.
Progressive Medicos and Scientists Forum on Friday, in a release, criticising the lawsuits noted that “Scientific literature is scrutinised via open correspondence and review by peers, not in silence of injunction forced by an army of corporate lawyers.”
Further noting that the study has its limitations, the forum emphasised the need to support studies on COVID-19 vaccines.
Recalling the Supreme Court’s observations emphasising the need for the collection of adverse event data, the forum stated, “Following media outlets’ misinterpretation of the study—leading to misinformation amongst general public, such as claims of causal links between the BBV152 vaccine and various health issues—ICMR instead of limiting itself to scientific criticism and issuing clarifications to dispel misinformation in public interest, went beyond the pale of ethical and acceptable by threatening legal action against BHU researchers wrongly blaming them for misinformation, thus preparing a ground for the BBIL defamation suit that followed.”
The release concluded by reiterating: “We believe that restricting the freedom of expression in scientific academia and transparency in medical research will only hinder societal progress and the larger public interest by gatekeeping the access to truth from the masses.”
The controversy continues to unfold, with observers noting that the outcome could have long-term implications for the scientific community, legal processes, and public perceptions of vaccine safety.
(Edited by Sumavarsha Kandula)
