ICMR distances itself from safety study on Covaxin
ICMR distances itself from BHU study on Covaxin safety, threatens legal action against authors for unauthorized acknowledgment.
The country’s apex biomedical research regulator, the Indian Council of Medical Research (ICMR), has distanced itself from a Banaras Hindu University (BHU) study that raised concerns on safety of Bharat Biotech’s Covid vaccine, Covaxin, and threatened legal action against the study’s authors for acknowledging ICMR’s support for a poorly designed study without its consent.
ICMR chief Rajiv Bahl has formally written to the researchers criticizing the research paper entitled “Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a 1-Year Prospective Study in North India”.
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“The Indian Council of Medical Research (ICMR) has been incorrectly and misleadingly acknowledged in the paper. ICMR is not associated with this study and has not provided any financial or technical support for the research. Further, you have acknowledged ICMR for research support without any prior approval of or intimation to ICMR, which is inappropriate and unacceptable. ICMR cannot be associated with this poorly designed study which purports to present a “safety analysis” of Covaxin,” said Bahl in the letter.
Bahl said the study had no control arm of unvaccinated individuals for comparing the rates of events between the vaccinated and unvaccinated groups. Hence, the reported events in the study cannot be linked or attributed to Covid-19 vaccination, he reasoned.
The ICMR DG has written a letter to the authors of the paper and Editor of the journal to immediately remove the acknowledgement to ICMR and publish a correction.
ICMR collaborated with Bharat Biotech on developing the inactivated vaccine. While there were concerns about the dose being launched without reaching adequate clinical trial stages, it was administered in millions and the post rollout adverse effects monitoring did not pick up any significant signs.
In a statement, Bharat Biotech 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 prior to participation in the study; comparison of safety profile of non-vaccinated subjects during the course of the study; comparison of safety profile of subjects who received other vaccines during the course of the study; all study participants should be followed during the course of 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.”
The paper stated that nearly one-third of the 926 participants in the study who received Hyderabad-based vaccine manufacturer’s Covaxin reported “adverse events of special interest”, or AESI. The study, conducted by researchers from the Banaras Hindu University from January 2022 to August 2023, claimed that nearly 50% of study participants complained of infections during the follow-up period.
Serious AESI, which included strokes and Guillain-Barre syndrome, were reported in 1% of individuals, the study, which looked at long-term safety of the BBV152 (Covaxin) vaccine in adolescents and adults, claimed.
The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine.
Bahl said that ICMR was acknowledged for research support without any prior approval of the study or intimation to ICMR, which is inappropriate and unacceptable. He stated that ICMR cannot be associated with this poorly designed study which purports to present a “safety analysis” of Covaxin due to several critical flaws. He said the study does not even provide background rates of observed events in the population, making it impossible to assess the change in incidence of observed events in the post-vaccination period. Baseline information of study participants is missing.
He pointed out more gaps too in his letter: “The study tool used is inconsistent with ‘Adverse Events of Special Interest (AESI)’ as defined in the reference provided in the paper for AESI. The method of data collection has a high risk of bias. Study participants were contacted telephonically one year after vaccination and their responses were recorded without any confirmation with clinical records or by physician examination.”
“The authors have been urged to immediately rectify the acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address the methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action,” said Bahl in his letter.
In another letter written to the Editor of Drug Safety Journal, Adis International Limited, Auckland, New Zealand, which published the paper, Nitin Joshi, Bahl has asked for the retraction of the paper that implicitly makes conclusions on vaccine safety which are not supported by evidence.
'Poor methodology': ICMR dissociates itself from Covaxin safety study
Some experts have also criticised the study methodology.
“I read through the study and found it sub-standard and not methodically sound… it has increased anti-vaccine sentiments within the public in India, who were already misinformed and mis-led by reports on extremely rare side effects of Covishiled (AZ vaccine)…,” wrote Dr Cyriac Abby Philips, hepatologist and clinician-scientist, on X.