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, according to a report published in Springer Nature recently. The report said that nearly a third of the participants of an observational study on the vaccine reported adverse events of special interest (AESI).
The one-year 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’, conducted by a team of researchers at Banaras Hindu University, also said that serious adverse events many occur in 1% of BBV152 recipients, and that extended surveillance is warranted following the administration of the vaccine.
Responding to a query from The Hindu on the study, Bharat Biotech maintained that for such a study in safety to be effective and informative, and for it to avoid investigator bias, some data points were also required, including the AESI safety profile of the subjects prior to their participation in the study; a comparison of the safety profile of non-vaccinated subjects during the course of the study; a comparison of the safety profile of subjects who received other vaccines during the course of the study; and that all study participants should be followed during the course of the study instead of only a subset.
