The study had stated that one-third of the 926 participants in the study, who received Bharat Biotech's anti-Covid vaccine Covaxin, reported 'Adverse Events of Special Interest,' or AESI.
The ICMR has requested the Editor of the Drug Safety Journal to retract the recently published study
The Indian Council of Medical Research(ICMR) Director General, Dr Rajiv Bahl, criticised a published study on the long-term safety analysis of the Covaxin in adults and adolescents for its poor methodology and design.
He clarified that the article misleadingly and erroneously “acknowledges” ICMR.
The ICMR has requested the Editor of the Drug Safety Journal to retract a recently published study on Covaxin side effects authored by researchers from Banaras Hindu University (BHU).
A research paper, titled ‘Long-Term Safety Analysis of the BBVl52 Coronavirus Vaccine in Adolescents and Adults: Findings from a l-Year Prospective Study in North India’ states that nearly one-third of the 926 participants in the study, who received Bharat Biotech’s anti-Covid vaccine Covaxin, reported ‘Adverse Events of Special Interest,’ or AESI.
Nearly 50 percent of 926 study participants in the study complained of infections during the follow-up period, predominated by viral upper respiratory tract infections.
Serious AESI, including stroke and Guillain-Barre syndrome, were reported in one percent of the individuals, the study claimed.
Dr Bahl said the study lacked a control arm of unvaccinated individuals to compare 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.
The ICMR is not associated with the study and has not provided any financial or technical support for the research, he said.
The ICMR DG has written a letter to the authors of the paper and the Editor of the journal to immediately remove the acknowledgement to ICMR and publish an erratum.
Dr Bahl said that ICMR was acknowledged for research support without any prior approval or notification 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 fails to provide background rates of observed events in the population, making it impossible to assess the change in the incidence of observed events in the post-vaccination period. Furthermore, baseline information of study participants is missing.
The study tool used is inconsistent with the definition of ‘Adverse Events of Special Interest (AESI)’ provided in reference cited in the paper, Dr Bahl continued, adding that the method of data collection carries 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, he pointed out.
Dr Bahl also noted that similar acknowledgements to ICMR have been made in previous papers without permission, raising concerns about the authors’ practices.
“The authors have been urged to immediately rectify the acknowledgment to ICMR and publish an erratum. Additionally, they have been asked to address the methodological concerns raised. Failure to do so may prompt ICMR to consider legal and administrative action,” he said.
The Editor has been asked to retract the paper which implicitly draws conclusions on vaccine safety that are not supported by evidence.
The study, conducted by researchers from the BHU from January 2022 to August 2023, stated that nearly 50 percent of 926 study participants in the study complained of infections during the follow-up period.
The study involved 635 adolescents and 291 adults, who received the BBV152 vaccine.
Published in the journal Springer Nature, the study comes in the wake of UK pharmaceutical giant AstraZeneca admitting its COVID-19 vaccine can cause rare side-effects of blood clotting and lowering of platelet count in UK court.
“Close to one-third of the individuals developed AESIs. New-onset skin and subcutaneous disorders, general disorders, and nervous system disorders were the three most common disorders observed in adolescents after receiving the vaccine,” the study, conducted from January 2022 to August 2023, said.
Reacting to the issue, the Banaras Hindu University has issued a statement.
“The Institute of Medical Sciences is looking into the matter. The individuals have communicated their responses to the ICMR. Additionally, the Institute of Medical Sciences is also working on further strengthening and improving its research ecosystem,” said the statement.
In a statement regarding the study to South First, Bharat Biotech said that for such a study to be effective, informative and to avoid investigator bias, other data points are also crucial.
This includes AESI safety profile of subjects before participating in the study, and a comparison of the safety profile of non-vaccinated people during the study and those who received other vaccines.
The pharmaceutical giant further said that several studies have been executed on the safety of COVAXIN, and published in peer-reviewed journals, demonstrating an excellent safety track record.
Dr Cyriac Abby Philips, a Kerala-based researcher and hepatologist, has criticized the study, describing it as “quite clownish.”
“Telephonic query. Thus playing into bias. A whole lot of bias. Telephonic interviews are the worst in measuring realistic primary events/outcome measures. There is no way to qualify or quantify it. Did they actually call these people included in the study? We do not really know because there is no raw data for us to analyze,” Dr Philips said.
He explained that AESIs are side effects that are not necessarily the same as AEFIs (Adverse Effects Following Immunization). In fact, AESIs can be considered a subset of AEFIs.
“In this study, the significant number of self-reported AESIs were actually observed in individuals with pre-vaccination comorbidities, meaning they were already at risk for such events regardless of their vaccination status. This suggests that the authors had predetermined the study results,” Dr Philips said.
“Many events marked as AESIs are known to be associated with COVID-19/long COVID. They could have been due to other flu/flu-like illnesses. But the study does not account for this, and a significant number of AESIs turn out to be upper respiratory tract infections (URTIs),” he continued.
“However, the authors did not test for COVID-19 or other infections. Conveniently, they claim ‘they can’t rule out it’s not COVID-19’ but fail to acknowledge that it could be COVID-19. It’s all in the phrasing, but it reveals their agenda—to promote anti-vaccine sentiments,” Dr Philips stated.
He also noted that one of the authors, Sankha Shubhra Chakraborty, from the Department of Geriatrics at BHU, is a prominent anti-vaxxer on Twitter, who frequently spreads vaccine misinformation.
“I am not tagging him here because he has been abusive towards me due to my posts on Ayurveda pseudoscience. He is also an alternative medicine sympathizer and a fanatic, who believes in miracles rather than science (go through his timeline if you have nothing else to do).”
“The BHU group, led by Sankha Shubhra Chakraborty and his co-authors, has been publishing low-quality, methodologically poor, and controversially biased papers for brief bursts of fame on social media,” Dr Philips said.
“The majority of the Indian media have been uncritically echoing their findings, adding anti-science fuel to the growing anti-vaccine sentiments among the public,” he concluded.
A lot of people have been sharing a recently published study on adverse events associated with Covaxin [Indian made Covid vaccine from Bharat Biotech] which was published in the journal, Drug Safety by a team from Banaras Hindu University, Varanasi, Uttar Pradesh.
I read through… pic.twitter.com/ajUqZ4hCYx
— TheLiverDoc (@theliverdr) May 18, 2024
(Edited by Shauqueen Mizaj)
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