The Drugs and Comptroller General of India (DCGI) is said to have authorised the administration of Bharat Biotech’s Covaxin to children aged 2 to 18.
According to the news agency ANI, the Subject Expert Committee (SEC) has approved the delivery of the anti-Covid vaccination to youngsters.
“The Subject Expert Committee (SEC) has recommended to the DCGI (Drugs Controller General of India) the use of BharatBiotech’s Covaxin for children aged 2 to 18,” the news agency tweeted.
vaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.
“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” a source quoted SEC as having stated in its recommendations.
The recommendations have been forwarded to the Drugs Controller General of India (DCGI) for final approval.
Speaking on the development, Dr E Venkata Rao, chief of clinical trial of Covaxin said, “In the phase-2 trial, it was confirmed that Covaxin can be administered to children above the age of 12 years. When the vaccine was rolled out, testing was conducted on the children between 2 and 18 years and it was found that the vaccine is safe and effective.”
“Even before the approval of the DCGI, we were of the view that Covaxin will be safe and effective on children, given the fact that it is being administered to pregnant women and breastfeeding women,” he added.