Bharat Biotech to present evidence of vaccine efficacy by February-March

Express News Service
NEW DELHI: A bare reading of the minutes of the three meetings the drug regulator’s expert panel held over the past week to consider accelerated licenses to coronavirus vaccines, indicates what was suspected all along — that the committee perhaps changed its mind on Covaxin overnight due to government pressure to clear a homegrown jab.

After three meetings spread over four days, the subject expert committee of the Central Drugs Standards Control Organisation on Covid-19 recommended restricted emergency use for Covishield by Serum Institute of India and Covaxin by Bharat Biotech-ICMR.

The approval to Covaxin, whose phase 3 trial on about 26,000 volunteers is still underway, however, led to a massive outcry in the scientific community as its efficacy is yet to be established.

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The minutes of the SEC’s meetings on December 30 and January 1 show it was not satisfied with Covaxin’s phase 1 and 2 trial data alone, but changed its mind on January 2.

December 30’s minutes say that “after detailed deliberation, the committee recommended that the firm should update and present immunogenicity, safety and efficacy data for further consideration.”

On January 1, it recommended that Bharat Biotech expedite the recruitment of volunteers and perform interim efficacy analysis for further consideration. In the same meeting, the panel recommended Covishield’s approval. 

However, the very next day when an unscheduled meeting was held purportedly under pressure to clear the indigenous vaccine, Bharat Biotech presented further data and notably “requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection”.

Introducing the protection angle against the infectious UK virus strain perhaps gave the SEC legroom for its somersault. The minutes show the committee echoed Bharat Biotech, as it observed that Covaxin has the “potential to target mutated coronavirus strains”.

‘Covaxin data demonstrates strong immune response’

“The data generated so far demonstrates a strong immune response (both antibody as well as T cell) and in-vitro viral neutralisation,” the committee said, adding Bharat Biotech presented the safety and efficacy data from a non-human primate challenge study where the vaccine was found to be safe and effective.

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“…after detailed deliberation, the committee recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations especially in case of infection by mutant virus,” the panel noted.