Govt Panel Recommends EUA For Serum Institute’s COVID Vaccine – Covovax – For 12-17 Age Group

The Drugs Controller General of India (DCGI) had approved Covovax for restricted emergency use in adults on December 28.

New Delhi: An expert panel of country’s central drug authority has recommended granting emergency use authorisation (EUA) to Serum Institute of India’s COVID-19 vaccine — Covovax –for the 12-17 age group, official sources said on Friday. The Drugs Controller General of India (DCGI) had approved Covovax for restricted emergency use in adults on December 28. However, it has not yet been included in the country’s vaccination drive.

Prakash Kumar Singh, Director-Government and Regulatory Affairs at Serum Institute of India (SII), had submitted an application to the DCGI on February 21, seeking EUA for Covovax for the 12 to 17 years age group. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday deliberated on SII’s application and recommended granting EUA to Covovax. The recommendation will be sent to the DCGI for approval, sources said.

In the EUA application, Singh is learnt to have stated that data from two studies on about 2,700 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well tolerated in this age group of children.

(With agency inputs)