Bharat Biotech’s Covaxin gets emergency use approval by the Subject Expert Committee on Covid-19 for children in the 2-18 years age group. Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs and Comptroller General of India (DCGI) in the first week of October.
Simultaneously, the WHO is looking in to grant emergency use authorization to Covaxin. Bharat Biotech had submitted all documents required for the listing to the WHO by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.
And today, India got its second COVID-19 vaccine for children with Bharat Biotech’s Covaxin approval. Zydus Cadila’s ZyCoV-D had previously received approved approval for all individuals aged 12 and above, this is the first jab to cater to younger children.