Bharat Biotech has submitted Phase 2/3 clinical trials data of Covaxin for children to the Drugs Controller General of India (DCGI), CNBC-TV18 has reported.
The DCGI will request its subject expert committee (SEC) to consider the request for Emergency Use Authorisation (EUA) for the vaccine against COVID-19, sources told the news channel.
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.
In the trial, Covaxin was administered to 525 children in the 2-18 age group.
ZyCoV-D, has been approved for children aged 12 and above as well as adults. However, the rollout has not yet begun.
The Centre is hopeful of a positive outcome from the final round of discussions with Zydus Cadila about its vaccine, Karnataka Health Minister K Sudhakar said on October 2.
Sudhakar made the statement after a meeting with Union health minister Mansukh Mandaviya.
“I had a lengthy discussion with the Union minister about children vaccination. He (Mandaviya) informed that the government is having a final round of discussion with Zydus with regard to its COVID-19 vaccine for children. He said he was hoping for a positive outcome soon,” he was quoted as saying by PTI.
Since the start of the inoculation drive, 66.7 lakh adults have taken at least one dose a COVID-19 vaccine, and 25.4 crore are fully vaccinated, according to the health ministry’s latest update.