Why COVID vaccine safety needs scrutiny | Explained

The story so far: The Indian Council for Medical Research issued a letter to the researchers of Banaras Hindu University last week, countering their study on the side effects of India’s indigenous vaccine for COVID — Covaxin. The one-year observational, follow-up study titled ‘Long-term safety analysis of the BBV152 coronavirus vaccine in adolescents and adults: Findings from a one-year prospective study in North India’, also said that serious adverse events occurred in 1% of BBV152 recipients, and that extended surveillance is warranted following the vaccine administration. In response to this, Bharat Biotech, the vaccine manufacturer which worked with the ICMR’s own National Institute of Virology to develop the vaccine candidate, said for such a study in safety to be effective and informative, and for it to avoid investigator bias, some data points were also required. He alleged that the authors had acknowledged ICMR for research support without prior approval or intimation to the institution, calling this “inappropriate and unacceptable.” With reference to the study itself, he claimed there were critical flaws: the study had no control arm of unvaccinated individuals for comparison with the vaccinated group, and therefore, the reported events in the study cannot be linked or attributed to COVID-19 vaccination; it did not provide background rates of patterns observed in the general population, and thereby made it impossible to study the observed events in the post vaccination period. “While we were hoping and expecting that the ICMR would build upon this study, address its shortcomings, and elevate the standards of vaccine safety, we are aghast to come across letters sent by ICMR asking for the retraction of the paper, and threatening the authors of the study,” it said.