The Drugs Controller General of India (DCGI) approved Covovax for 12-17 years after the Subject Expert Committee on COVID-19 of the CDSCO last week recommended granting emergency use authorisation (EUA). It was authorized by DCGI to the Serum Institute subject to certain conditions.
Adar Poonawalla, CEO of Serum Institute said confirming the DCGI approval, “@SerumInstIndia’s brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorization by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly”.
To receive the regulator’s nod, this is the fourth vaccine to be used for people below 18years but the government only approved Bharat Biotech’s Covaxin is used for the 15-18 years age group in the vaccination drive.
The decision to vaccinate below 15 years is still pending and the health ministry has repeatedly said that the additional need for vaccination and inclusion of population for vaccinations are examined constantly.̧
A statement in the EUA application to DCGI was made by Prakash Kumar Singh, director (government and regulatory affairs) at SII, in which it was stated that Covovax is highly effective, immunogenic, safe, and well-tolerated in about 2707 children aged 12 to 17 years.