COVID-19 Mutant Strain Threat Prompted Covaxin’s Approval, Say Minutes Of SEC Meetings
New Delhi: The impending danger of the new mutant strain of coronavirus found in the UK helped Bharat Biotech get emergency use approval for its vaccine candidate Covaxin. India has now reported 71 cases of mutant strain with number rising each day.
The Subject Expert Committee (SEC) meeting of the Central Drugs Standard Control Organisation (CDSCO), however, showed it changed its stance regarding Bharat Biotech’s vaccine candidate.
In three meetings, SEC changed its decision from insisting on efficacy data to approving Covaxin under the ‘clinical trial mode’ sans the Phase 3 clinical trials data, reported India Today.
According to the minutes, SEC insisted on efficacy data between December 30 and January 1. On January 1, 2021, the same SEC asked Bharat Biotech to expedite the hiring process and furnish interim efficacy data.
However, it approved emergency use authorisation to Covaxin on January 2 under the mysterious ‘clinical trial mode’.
“In light of the recommendations of the committee dated 01.01.2021, the firm further presented the updated data, justification and requested for consideration of their proposal in the wake of incidence of new mutated coronavirus infection. As already noted by the committee, this vaccine is Inactivated Whole Virion, coronavirus vaccine having the potential to target mutated coronavirus strains,” said minutes of the SEC meeting on January 2 as quoted by India Today.
However, minutes of the December 30 meeting quoted the SEC as saying, “After detailed deliberation, the committee recommended that the firm should update and present immunogenicity, safety and efficacy data for further consideration.”