Covaxin was approved for restricted use in an emergency situation by the Drug Controller General of India on January 3. However, since Bharat Biotech had not finished recruiting and vaccinating enough participants for Phase 3 trials, the approval was without efficacy data.
So far, the vaccine has been administered to healthcare and frontline workers “in clinical trial mode” as part of the government’s mass vaccination campaign against the coronavirus.
The Hyderabad-headquartered vaccine maker said the first interim analysis is based on 43 cases, of which 36 cases of Covid-19 were observed in the placebo group versus seven cases observed in the Covaxin group, resulting in a point estimate of vaccine efficacy of 80.6 per cent.
The interim analysis showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups, the company added.
The Phase 3 trial results assume significance as the company had approached the Central Drugs Standard Control Organisation (CDSCO) for approval to conduct late-stage clinical trials of Covaxin in children aged 5-18.
The Indian Express had learned that the Subject Expert Committee (SEC) that was looking into the request had told the vaccine-maker to submit data on Covaxin’s efficacy in adults.
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