Serum Institute’s COVID-19 vaccine Covovax becomes the fourth vaccine to receive the restricted emergency use authorization by India’s drug regulator for the 12-17 years age group subject to certain conditions.

On Tuesday, the CEO of Serum Institute of India confirmed the DCGI approval and tweeted that Covovax had been granted Emergency Use Authorization by DCGI for adults and children above the age of 12 and the younger age groups will follow shortly.

Prakash Kumar Singh, director (government and regulatory affairs) at SII, in the EUA application to DCGI on February 21 stated that the data from 2707 children aged 12 to 17 years included in two studies showed the Covovax was effective, safe and well-tolerated in the studied age group and the approval would be beneficial not only for India but the whole country.

Last week, the Subject Expert Committee on COVID-19 of the CDSCO recommended the grant of emergency use authorization (EUA) to Covovax for those aged 12 to 17, following which the Drugs Controller General of India (DCGI) gave EUA for the same.

Covovax has been already approved for restricted use in emergencies in adults on December 28 by the DCGI, but yet not introduced in the countrywide vaccination drive. 

In previous approvals, the DCGI granted restricted EUA to Biological E’s COVID-19 vaccine Corbevax for the 12-18 years age group, under certain conditions on 21st Feb  22.

Covaxin is the country’s only vaccine being administered to children in the countrywide vaccination drive. Last year in August, ZyCov-D was also approved by India’s drug regulator for inoculation of those aged 12 years and above.

Source: ET Healthworld