The Subject Expert Committee (SEC) has approved Bharat Biotech phase 3 trials efficacy data, various media reports said citing sources. According to the data submitted, Covaxin has shown 77.8 per cent efficacy in the Phase 3 trials for the vaccine that were conducted on 25,800 subjects.
The SEC has reviewed Bharat Biotech’s data, but no approval has been given yet. The expert panel met on Tuesday afternoon to review the Covaxin trial results. An official announcement is still being awaited.
Post the SEC review, the data will be forwarded to the Drugs Controller General of India (DCGI) for review.
Last week, Bharat Biotech had said that it will make the data public in July. “Once data from final analysis of phase 3 studies are available, Bharat Biotech will apply for full licensure for Covaxin,” the company had said. It had been facing criticism for not sharing its phase three trial data nearly six months after its vaccine was granted emergency-use authorisation in India. In January, the company had said it would submit efficacy results by March.
In April, an interim analysis of Covaxin’s phase three data had shown that it was 78 per cent effective against Covid-19. This was slightly lower than the 81 per cent efficacy reported by the company in March.