According to a one-year follow-up study by researchers at BHU, nearly one-third of individuals who received Bharat Biotech’s Covaxin reported 'adverse events of special interest' (AESI).
Nearly 50% of the 926 participants in the study reported experiencing infections during the follow-up period, with viral upper respiratory tract infections being the most common.
The study, which examined the long-term safety of the vaccine in adolescents and adults, also noted that AESI, such as stroke and Guillain-Barre syndrome, were reported in 1% of the participants.
Negating the study, the vaccine maker, Bharat Biotech, claimed that several studies have been executed on the safety of Covaxin and published in peer-reviewed journals, demonstrating an excellent safety track record.
Bharat Biotech stated that for a safety study to be effective, informative, and free from investigator bias, all study participants should be followed throughout the study, rather than only a subset.
They mentioned the need for the AESI safety profile of subjects prior to participation, a comparison of the safety profile of non-vaccinated subjects during the study, and a comparison of the safety profile of subjects who received other vaccines during the study.
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