Expert panel recommends Covaxin for children between 2 and18 years
- EP News Service
- Oct 12, 2021
NEW DELHI: The Subject Expert Committee (SEC) under India's drug regulator The Drugs Controller General of India (DCGI) has given a nod for use of Bharat Biotech's Covaxin for children in the 2-18 years age group.
The SEC usually takes a decision after thoroughly reviewing the data provided by the vaccine manufacturer however the final decision on administering the vaccine to the pediatric population in the country will have to be taken by the DCGI which is likely shortly. After the DCGI final go-ahead, the governemt may take a decision to include it in COVID-19 immunisation campaign.
The nod of the SEC comes after Bharat Biotech submitted data from clinical trials in the two - 18 age group for Covaxin to CDSCO (Central Drugs Standard Control Organisation) as per which the vaccine has been found to be safe and efficacious in children.
The efficacy data submitted by Bharat Biotech on Covaxin in June is 77.8 per cent effective in protecting against the virus. The World Health Organisation's (WHO) approval for the emergency use authorisation (EUA) for Covaxin has not yet been received and is likely to come shortly.
Covaxin is the first whole-cell inactivated vaccine approved for use and the first in the world for children as small as two years. According to reports while data on these trials has not been made public yet, but tests were conducted on 1,000+ children across the country. The trials have noted that the vaccine showed similar efficacy rates as that on adults.
Pediatric vaccine Novavax from Pune based Serum Institute for kids was cleared for trials for children between seven and 11 years a month ago by DCGI, while another one from Biological E's Corbevax, has been cleared to conduct advanced trials on children above five.