Govt Panel Recommends Granting Emergency Approval To Covovax For 12-17 Age Group

Prakash Kumar Singh, the Director of Government and Regulatory Affairs at SII, had earlier submitted an application to the DCGI on February 21 seeking EUA for Covovax

Govt Panel Recommends Granting Emergency Use Authorisation To Covovax For 12-17 Age Group (File Image)

New Delhi: An expert committee of the central drug authority of the country recommended granting emergency use authorisation (EUA) to India-manufactured Covovax for the age group of 12-17, on Friday.     

Prakash Kumar Singh, the Director of Government and Regulatory Affairs at Serum Institute of India (SII), had earlier submitted an application to the DCGI on February 21 seeking EUA for Covovax for the age group of 12 to 17 years.

In his application, Singh had stated that according to two studies conducted on 2,700 children in the age group concerned, Covovax was found to be highly efficacious, immunogenic, safe and well tolerated.

Based on this application, the Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Friday recommended granting EUA to Covovax. The recommendation will now be sent to DGCI for approval, sources close to news agency PTI said.

"This approval will not only be beneficial for our country alone, but will benefit the entire world, fulfilling our Prime Minister's vision of 'Making in india for the World'. In line with the philosophy of our CEO Adar C Poonawalla, we are sure that Covovax will play an important role to protect children of our country and world at large against Covid-19 disease and will keep our national flag flying high globally," a PTI source had quoted Singh as having stated in the application.

Notably, the DCGI had approved Covovax for restricted use in emergency situation in the adults on December 28. However, it has not yet been included in the country's vaccination drive.

Covovax is manufactured by technology transfer from Novavax, and is approved by the European Medicines Agency for the conditional marketing authorization. It was also granted emergency use listing by WHO on December 2017, 2020.

Currently, India has been using Bharat Biotech-manufactured Covaxin to vaccinate adolescents between 15-18 years.