Official sources said on Friday that an expert panel of the country’s federal drug regulator recommended awarding emergency use authorisation (EUA) to Serum Institute of India’s COVID-19 vaccine Covovax for the 12-17 age range.
On December 28, the Drugs Controller General of India (DCGI) authorised Covovax for limited usage in emergency situations in adults.
It is yet to be incorporated into the country’s immunisation campaign.
On February 21, Prakash Kumar Singh, Director-Government and Regulatory Affairs at the Serum Institute of India (SII), applied to the DCGI for an EUA for Covovax for children aged 12 to 17.
On Friday, the Central Drugs Standard Control Organisation’s (CDSCO) Subject Expert Committee on COVID-19 debated on SII’s application and recommended that Covovax be granted EUA.
According to sources, the recommendation will be given to the DCGI for approval.
Singh is said to have indicated in the EUA application that results from two trials involving around 2,700 children aged 12 to 17 years suggest that Covovax is highly effective, immunogenic, safe, and well tolerated in this age range.
“This permission will benefit not just our nation, but the whole globe, bringing our Prime Minister’s goal of “Making in India for the World” to fruition.
We are confident that, in keeping with our CEO Adar C Poonawalla’s philosophy, Covovax will play an important role in protecting children in our country and around the world from COVID-19 disease, and will keep our national flag flying high around the world “Singh had previously stated in the application, according to an official source.
Covovax is made through a technology transfer from Novavax and has been awarded conditional marketing authorisation by the European Medicines Agency, as well as emergency use listing by the World Health Organization (WHO) in December 2017 and 2020.
