Serum Institute of India’s COVID-19 vaccine Covovax has been granted emergency use authorisation (EUA) for the 12-17 age group, said official sources on Friday. Covovax is already available for restricted use in emergency situation. The permission was granted by the Drugs Controller General of India (DCGI) on December 28. It has not yet been included in the country’s vaccination drive.
An application to the DCGI was submitted by Prakash Kumar Singh, Director-Government and Regulatory Affairs at Serum Institute of India (SII), on February 21. The application sought EUA for Covovax for the 12 to 17 years age group.
Sources said that 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.
“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,” an official source had quoted Singh as having stated in the application earlier.
Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO on December 2017,2020. India has been using Bharat Biotech’s Covaxin to vaccinate adolescents between 15-18 years.