Covaxin gets emergency use approval for children aged 2-18 years

New-Delhi: The Subject Expert Committee (SEC) on Covid-19 has granted emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group.

The Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and had submitted the trial data to the Drugs and Comptroller General of India (DCGI).

The emergency use authorisation, however, is subject to certain conditions. The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.

Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin. Bharat Biotech had reportedly submitted all documents required for the listing to the WHO by July 9.

 
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