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 the move. 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. “In this emergency situation, if the benefit is more, then it may be considered. Numbers are there — from phase 1, we get the safety data. And from phase 1 and 2, we get safety-immunogencity data.”

He added that this data was available for many vaccines covering a period of several months. “These numbers are available for different vaccines, on a very small number of participants…the risk-benefit is the most important thing to look at in a pandemic situation, but ultimately the national regulatory authority has to take the decision.” At least two experts working closely with the regulator on this process said that in a risk-benefit analysis during a pandemic, one had to first look at the safety parameters of the candidate, and then evaluate its efficacy…Read More

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