One more shot: vaccines, counters and flip flops

This week in Health Matters newsletter: the contentious BHU study on Covaxin, use of AI in drug development and the latest update on West Nile Virus.

This week in health: the contentious BHU study on Covaxin, use of AI in drug development and latest update on West Nile Virus.

Famous last words. Or, first. We wondered if the sordid vaccine issue had been set to rest, last week, but that is not to be. In the endless, sometimes cyclical news cycle, things get pushed up to the top, inevitably, in similar avatars, or different, seeking resolution or conclusion. Often there is no conclusion, just endless episodes and series that keep the story going long, long after the show started. While last week, the health community was all aflutter with the Covishield side effects controversy, this week, it has been about Covaxin, a study and a consequent flip flop. 

Bindu Shajan Perapaddan reported the study done by the Benares Hindu University researchers and published in Springer Nature recently. It concluded that adolescent girls and those with comorbidities are at a higher risk of adverse events after receiving Bharat Biotech’s BBV152 (Covaxin) vaccine against COVID-19. Further, it said that nearly a third of the participants of an observational study on the vaccine reported adverse events of special interest (AESI). Among adolescents, female individuals, those with a history of allergy and post-vaccination typhoid were respectively at 1.6, 2.8, and 2.8 times higher risk of AESIs. The majority of the AESIs persisted at the 1-year follow-up. Female individuals, adolescents with pre-vaccination COVID-19, those with comorbidities, and those with post-vaccination typhoid had respectively 1.6, 2, 2.7, and 3.2 times higher odds of persistent AESIs. Adults with comorbidities had more than 2 times higher odds of AESIs and persistent AESIs,” the paper said.

But that was not all. In a counter to the study, the Indian Council of Medical Research, that was acknowledged in the original paper, distanced itself, in a couple of days. In its letter to the researchers, the ICMR said the body has not provided any financial or technical support for the research. ICMR director general Rajiv Bahl called the paper “poorly designed” and said it “incorrectly and misleadingly” acknowledges financial or technical support from the ICMR. “ICMR cannot be associated with this poorly designed study,” the director general’s letter says, and calls for an immediate retraction of the hat tip to ICMR from the article, and publish an Erratum. “We have also noticed that you have similarly acknowledged ICMR in similar previous papers without permission. Please explain why ICMR should not seek legal and administrative action against you,’’ it notes. 

What were the flaws in the study? According to the ICMR, it does not have a control group of unvaccinated individuals to prove that the side effects are indeed associated with vaccination. Also, it does not mention how frequently these adverse events were reported by the sample population to establish that they were associated with vaccination, the study tool was not consistent with the definition of “adverse events of special interest” that is globally accepted and lastly the responses of the participants were recorded one year after immunisation without verification of any clinical records or physician examination, increasing the chances of biased reporting.

BHU issued a statement later saying: “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,” the BHU said. 

Let’s note the bizarre circumstances of this publication and the counter, while we acknowledge that much more needs to be done in the country to regulate scientific research and hold it up to the highest accountable standards. The ICMR’s sudden discovery of the use of its research, data or even merely name belatedly is also something that rankles. We’ll stay on this story, you stay with us.