- DCGI has approved Covovax for inoculating adults and children aged 12 to 17.
- The approval comes after the Subject Expert Committee on COVID-19 recommended the EUA.
Serum Institute of India's CEO Adar Poonawalla on Wednesday informed that its vaccine Covovax has received emergency use authorization (EUA) by the DCGI. The approval has been granted for the administration of the Covid 19 vaccine to adults and to children aged above 12. It is the fourth vaccine to receive the regulator's nod for use among those below 18 years.
The Drugs Controller General Of India's (DCGI) approval comes after the Subject Expert Committee on COVID-19 of the CDSCO last week recommended granting emergency use authorization (EUA) to Covovax for those aged 12 to 17.
"Novavax in global trials has demonstrated more than 90% efficacy", said SII CEO Adar Poonawala.
The government has still not not taken a decision on vaccinating those aged below 15 years. The health ministry has consistently said that additional needs for vaccination and inclusion of population for vaccination are examined constantly.
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.
(With PTI Inputs)