Serum Institute of India’s COVID-19 vaccine Covovax becomes the fourth vaccine to receive the restricted emergency use authorization (EUA) 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: "@SerumInstIndia’s brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and children above the age of 12. Younger age groups will follow shortly.”

Last week, the Subject Expert Committee on COVID-19 of the CDSCO recommended the grant of EUA to Covovax for adolescents aged 12 to 17 years. The vaccine was already approved for adults on December 28 by the DCGI, but has not been introduced in the countrywide vaccination drive yet.

Prakash Kumar Singh, director (government and regulatory affairs) at SII, in the EUA application to the DCGI, 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 world… (ET Healthworld – PTI, March 10, 2022)