Bharat Biotech submits Covaxin clinical trials data on children to DCGI
Till now, the company has completed its Phase 2 and Phase 3 trials of Covaxin on children below 18 years of age in September.
FollowBharat Biotech has submitted India’s first indigenous vaccine Covaxin’s Phase 2/3 clinical trials data for children to the Drugs Controller General of India (DCGI).
Till now, the company has completed its Phase 2 and Phase 3 trials of Covaxin on children below 18 years of age in September.
The DCGI will request its subject expert committee (SEC) to consider the request for Emergency Use Authorisation (EUA) for the vaccine against COVID-19, CNBC-TV18 reported.
Two doses of Covaxin will be administered to children with a gap of 28 days, the report said. For adults, the government has set a gap 4-6 weeks between the two shots.
Covaxin was administered to 525 children in the 2-18 age group during the trial.
According to the World Health Organisation, the evaluation to seek Covaxin as an emergency use listing(EUL) is likely to complete at the end of October.
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Bharat Biotech chairman Dr Krishna Ella was quoted by India Today saying, the organisation has submitted the required data to theWorld Health Organization, an agency of United Nations. He further added that Bharat Biotech has been given approvals for their other vaccines and are used based on the approval procedure.
As per WHO’s listing, the company has already submitted all the necessary documents by July 9. The World Health Organization takes at least six weeks to review the process.
Meanwhile, ZyCoV-D, has been approved for children aged 12 and above as well as adults. However, the rollout has not yet begun.
Karnataka Health Minister K Sudhakar said on October 2 that the Centre is hopeful of a positive outcome from the final round of discussions with Zydus Cadila about its vaccine.
Speaking to reporters, Sudhakar said, “I had a detailed discussion with the Union Minister about children’s vaccination. He informed that final discussions are on with Zydus with regard to its Covid-19 vaccine for children and a positive outcome is expected. Bharat Biotech Chairman and Managing Director Krishna Ella was also present. He told us that the second clinical trial of a nasal vaccine developed by them was completed, and the third is expected by November-December,” he added.
