Covid vaccine: Bharat Biotech gets 23,000 volunteers for Covaxin Phase 3 trials

Hyderabad-based vaccine manufacturer Bharat Biotech on Saturday announced successful recruitment of 23,000 volunteers and continued progress towards achieving the goal of 26,000 participants for the phase 3 trial of its coronavirus vaccine candidate Covaxin in India.

In a statement, Bharat Biotech said that the Phase III human clinical trials of Covaxin began in mid-November. It is also the largest phase III efficacy trial ever conducted for any vaccine in the country, as per the statement.

"Phase-3 human clinical trials of Covaxin began mid-Nov, targetted to be done in 26,000 volunteers across India, this is India's first and only phase-3 efficacy study for Covid-19 vaccine, and largest phase-3 efficacy trial ever conducted for any vaccine in India," it added.

Bharat Biotech's statement comes minutes after a government panel today recommended Covaxin for "restricted use in an emergency situation in the public interest".

DCGI to take final call on vaccine approval

The Drugs Controller General of India (DCGI) will take the final call on approving the Covid-19 vaccine. The national regulator is scheduled to address the media tomorrow at 11 am.

The subject expert committee (SEC) of Central Drugs Standards Control Organisation (CDSCO) has made recommendations for "grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd, Hyderabad," the health ministry said in a statement.

The SEC's decision is likely to soon be followed by a final authorisation by DCGI VG Somani, who heads the CDSCO. Typically, the DCGI clears a proposal for approval or emergency licence when it is recommended by the SEC.

Covaxin -- a highly purified and inactivated two-dose SARS-CoV2 vaccine -- has completed only two of three trial phases; the third - which tests for efficacy and which the company has called "the largest... ever conducted for any vaccine in India" - began in mid-November.