Serum Institute seeks EUA for its Covovax vaccine for 12-17 yrs age group

Serum Institute of India has sought emergency use authorisation from India's drug regulator for its COVID-19 vaccine Covovax for the 12 to 17 year age group, official sources said on Monday.

The government has not yet decided on vaccinating those aged below 15.

The Health Ministry had recently said the additional need for vaccination and inclusion of population for inoculation is examined constantly.

In the application for emergency use authorisation (EUA) for the 12-17 year age group, Prakash Kumar Singh, Director, Government and Regulatory Affairs at SII, is learnt to have stated that data from two studies on about 2,707 individuals aged 12 to 17 years show Covovax is highly efficacious, immunogenic, safe and well-tolerated in this age group.

"We are submitting our application along with documents for grant of permission for restricted use in emergency situation for Covovax vaccine in children aged 12 to 17 years in addition to approved age of individuals 18 years and older," an official source quoted Singh as having said in the application.

This approval will not only be beneficial for the country but will also benefit the world, fulfilling Prime Minister Narendra Modi's vision of 'Making in India for the World', Singh is learnt to have said.

"In line with the philosophy of our CEO Dr Adar C Poonawalla, we are sure that Covovax will play an important role in protecting the children of our country and the world against COVID-19 and will keep our national flag flying high globally," Singh stated.

The Drugs Controller General Of India has already approved Covovax for restricted use in emergency situations in adults on December 28.

Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation.

It has been granted emergency use listing by the World Health Organisation on December 17, 2021.

India has been using Bharat Biotech's Covaxin to vaccinate adolescents between 15 and 18 years.