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How Covaxin continues to be targeted by vested interest groups: ICMR rejects BHU ‘study’ that claimed adverse effects, doctors highlight misleading methods

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.

On 20th May, the Indian Council of Medical Research (ICMR) strongly refuted the claims made by a recent ‘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.

Criticising the study for lacking scientific rigour, ICMR Secretary and Director General, Rajiv Bahl, stated that no support was provided by ICMR for the research. Bahl asserted, “The 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.”

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.

Bahl said, “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.”

ICMR to take legal action

ICMR has demanded that the university and the authors remove the acknowledgement on behalf of ICMR to be removed from the study with immediate effect. They also demanded a corrigendum to be published by the researchers and the university. The agency warned of potential legal action as the publications used their names without permission previously as well. Please explain why ICMR should not seek legal and administrative action against you,” Bahl’s letter stated.

BHU’s response

Responding to ICMR’s reaction, BHU issued a statement and acknowledged the concerns raised by ICMR about the study. The university emphasised that it is committed to improving its research ecosystem and mentioned that the Institute of Medical Sciences is reviewing the matter. BHU said, “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.”

In its study, BHU scholars claimed that 50% of the participants complained of infections during the follow-up period. Adverse Events of Special Interest or AESI included strokes, and Guillain-Barre syndrome that was reported in 1% of the individuals by the researchers. The study involved 635 adolescents and 291 adults.

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.”

The controversy revolving around Covaxin came at the time when Oxford–AstraZeneca COVID‑19 vaccine, Covishield, which was manufactured by Serum Institute of India for Indian recipients, also came under scrutiny after AstraZeneca admitted in the court again that it may result in severe side effects.

In a recent statement in a UK court AstraZeneca admitted that the AZ vaccine can, in very rare cases, cause TTS. The causal mechanism is not known. “Our sympathy goes out to anyone who has lost loved ones or reported health problems. Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” AstraZeneca said in a statement.

Notably, the chances of rare side effects of possible TTS or blood clotting are just 3-4 cases in a million-strong population, and the effects are seen within a few weeks of vaccination, that too after the first dose itself.

Ayodhra Ram Mandir special coverage by OpIndia

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Anurag
Anurag
B.Sc. Multimedia, a journalist by profession.

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