The Drugs Controller General of India (DCGI), has granted restricted emergency use authorisation to Serum Institute of India's Covid-19 vaccine Covovax for the 12-17 years age group subject to certain conditions, official sources said on Wednesday.

The 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.

"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, Dr 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.

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.

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.