In the latest development, the Serum Institute of India's vaccine Covovax has been granted Emergency Use Authorisation by the Drugs Controller General Of India (DCGI) for adults and for children above the age of 12.
"Younger age groups will follow shortly. Novavax in global trials has demonstrated more than 90% efficacy," said SII CEO Adar Poonawala.
It is the fourth vaccine to receive the regulator's nod for use among those below 18 years.
The emergency use approval comes after the Subject Expert Committee on COVID-19 of the CDSCO last week recommended granting emergency use authorisation (EUA) to Covovax for those aged 12 to 17.
In the EUA application to DCGI, Prakash Kumar Singh, director (government and regulatory affairs) at SII on February 21 had stated that the data from two studies on about 2707 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well tolerated in this age group of children.
The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28. It has not yet been included in the country's vaccination drive.
The DCGI on February 21 granted restricted EUA to Biological E's COVID-19 vaccine Corbevax for the 12 to less than 18 years age group subject to certain conditions.
