Bharat Biotech International (BBIL) had changed the dosage from 3 micrograms of antigen to 6 micrograms during its Covid-19 vaccine trial, a point that the subject expert committee (SEC) would closely examine when it meets on 9th December 2020 to review its application for an emergency use authorisation (EUA) for Covaxin.
The panel would also review the applications of Pfizer-BioNTech and Serum Institute of India (SII) seeking a EUA for their vaccines.
While many have raised questions over BBIL applying for a EUA during an ongoing efficacy trial, the Indian Council of Medical Research (ICMR), the country’s apex health research institute, has defended the move.
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