Expert panel set to review Pfizer-BioNTech, SII vaccine applications today

ICMR Director General Balram Bhargava said that in the case of temporary licensure or emergency use, the regulator had to be satisfied with the risk-benefit ratio.

Hyderabad-based 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 Wednesday 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 an EUA for their vaccines.

While many have raised questions over BBIL applying for an EUA during an ongoing efficacy trial, the Indian Council of Medical Research (ICMR), the country’s apex health research institute, has defended