New Delhi: Days after Bharat Biotech was recommended to undertake interim efficacy analysis to receive restricted emergency use for its Covid vaccine, India's drug regulator granted approval to the firm, the minutes of meetings accessed by IANS have revealed.
The three meetings of the Subject Expert Committee (SEC) held between December 30, 2020 and January 2, to examine the accelerated approvals for the Covid vaccines, showed a sudden change before recommending Bharat Biotech's vaccine for restricted emergency use.
As per the minutes, on December 30, the SEC concluded that the firm should update and present immunogenicity, safety and efficacy data for further consideration. The conclusion was based on the updated recruitment status and safety data including the serious adverse events that occurred in the Phase 3 clinical trial ongoing in the country.
On January 1, the committee recommended that the firm should perform interim efficacy analysis for further consideration of restricted emergency use approval.
However, the next day, the committee recommended that the firm be granted the permission for restricted emergency use in clinical trial mode. The committee noted that Bharat Biotech's vaccine is inactivated whole virion, coronavirus vaccine with potential to target mutated corona strains of the virus.
The SEC recommended it as "more options for vaccinations, especially in case of infection by mutant strains".
The restricted emergency use was approved for Bharat Biotech's vaccine by the Drug Controller General of India on January 3.
Interestingly, the minutes also revealed that the Bharat Biotech requested the committee to consider its vaccine for the emergency use approval in the wake of incidences of new mutated coronavirus infection which is said to have arrived from the UK.
However, during a press conference held by the firm on Monday, its CMD Dr Krishna Ella stated that the vaccine's efficacy over the UK strain is under study and he would require a week to present the "confirmative data" before the public.
The statement by Ella and his request to the SEC suggest that the restricted emergency use to its Covid vaccine Covaxin, was granted on the basis of its potential and not on the concrete data ascertaining its efficacy over the mutant strains of the novel coronavirus.
The All India Drug Action Network (AIDAN) questioned the sudden shift in SEC's recommendation before approving Bharat Biotech's vaccine for restricted emergency use.
"We are perplexed at the abrupt change in thinking of the SEC from the first two meetings to the third day on which the approval was recommended, while apparently discounting the need for efficacy data as the condition of the approval," Malini Aisola, co-convenor of AIDAN told IANS.
"The hesitation of the SEC in granting REU approval in the absence of any efficacy data has been documented in the meetings," she added.
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