Why has India's top medical body, ICMR, slammed the study on Covaxin side effects?

Days after Banaras Hindu University (BHU) researchers’ study on the side effects experienced by some people who took Bharat Biotech’s Covaxin came to light, the Indian Council of Medical Research (ICMR) has distanced itself from the research.

Calling it a “poorly designed study”, India’s premier medical research body pointed out methodological flaws in the paper.

The BHU study published by Springer Nature came amid reports of AstraZeneca’s admission that its COVID-19 vaccine can cause a rare side effect.

What did the BHU study say? Why has the ICMR taken objection to it? Let’s find out.

BHU study on Covaxin

According to the paper, researchers reached out to 1,024 adolescents and adults in January 2022  who were administered Covaxin.

These individuals were contacted via telephone 14 days after immunisation and asked whether they experienced any side effects.

The researchers again got in touch with these individuals one year later – in August 2023 – when 926 of the 1,024 participants responded. They were asked whether they still faced any symptoms or had developed any long-term adverse events of special interest (AESIs).

The study claimed that more than 40 per cent of 926 participants complained of upper respiratory tract infections.

About 10.5 per cent of adolescents developed new skin or under-skin disorders, general disorders (10.2 per cent), and 4.7 per cent experienced nervous system disorders, as per the research.

In adults, 5.8 per cent complained of musculoskeletal disorders and 5.5 per cent reported nervous system disorders.

About 4.6 per cent of female participants reported menstrual abnormalities.

Among serious adverse effects, about 0.3 per cent of participants experienced strokes and 0.1 per cent had Guillain-Barre syndrome – a rare condition wherein a person’s immune system attacks the peripheral nerves.

“Our findings are confined to BBV152 (Covaxin) and should not be extrapolated to viral vector or mRNA vaccines. The study primarily involved adolescents and the sample size of adults was relatively small. Larger adult-based studies are needed to understand long-term safety of BBV152 in adults,” the authors of the study said.

Why has ICMR dismissed the study?

ICMR has criticised the study over certain flaws. The medical body says that the study did not have a control group of unvaccinated individuals to prove the side effects were linked to vaccination, as per an Indian Express report.

It also underlines that the researchers failed to mention the frequency of these adverse events experienced by the participants to connect it with India-made Covaxin jabs.

The study tool was also inconsistent with the globally-accepted definition of “adverse events of special interest”, the report added.

The method of data collection of contacting the participants via phone a year after vaccination to record their responses without verification of their clinical records or physician examination was also flagged by ICMR.

It has to be noted that ICMR, which has the virus isolate for Covaxin, gets a royalty from the vaccine, reported Indian Express.

ALSO READ: After AstraZeneca side effect, adverse events in some who took Covaxin. Is it a reason to worry?

ICMR head shots off letter

ICMR Director-General Dr Rajiv Bahl wrote a letter to the authors of the paper and the editor of the journal that published it, saying that the study “incorrectly and misleadingly” acknowledges the apex medical research body and asked them to remove the acknowledgment.

Dr Bahl said ICMR has not provided any technical or financial support for the paper.

“The authors are urged to rectify acknowledgment to ICMR and publish an erratum. Additionally, they are asked to address methodological concerns raised,” the ICMR chief said.

“Failure to do so may prompt ICMR to consider legal and administrative action.”

“ICMR cannot be associated with this poorly designed study,” the letter says.

Bharat Biotech responds

Last week, Hyderabad-based vaccine maker Bharat Biotech said that any study on Covaxin and its side effects should take into account a wide range of data to avoid investigator bias. It also stated that comparisons should have been made with non-vaccinated individuals, along with the safety profile of people who took other vaccines.

“Several studies have been executed on the safety of Covaxin and published in peer reviewed journals, demonstrating an excellent safety track record,” it asserted, as per Businessline.

Covaxin and AstraZeneca’s COVID-19 vaccine , which was sold as Covishield in India, were the two main vaccines administered during India’s immunisation drive.

Concerns about the safety of Covishield arose recently after AstraZeneca admitted its vaccine can cause a rare side effect of blood clotting. The British-Swedish pharma giant announced a global withdrawal of its vaccine but attributed it to commercial reasons, citing “surplus of available updated vaccines” for COVID-19.

With inputs from agencies