Lagatar24 Desk
New Delhi, March 9: The Serum Institute of India’s Covovax has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12, officials said on Wednesday.
It’s the fourth vaccine to be approved by the FDA for use in children under the age of 18. The permission by the Drugs Controller General of India (DCGI) comes after the CDSCO’s Subject Expert Committee on COVID-19 recommended last week that Covovax be given an emergency use authorization (EUA) for individuals aged 12 to 17.
The government has yet to make a judgement on whether or not children under the age of 15 should be vaccinated. The health ministry has continually stated that increased immunisation needs and population inclusion for vaccination are always being assessed.
Prakash Kumar Singh, director (government and regulatory affairs) at SII, stated in the EUA application to DCGI on February 21 that data from two studies involving 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.
