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The Drugs and Comptroller General of India (DCGI) has reportedly approved the administration of Bharat Biotech's Covaxin to children in the 2-18 years age group.
According to news agency ANI, the Subject Expert Committee (SEC) has given the necessary approval for the administration of the anti-Covid vaccine to children.
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"Subject Expert Committee (SEC) has given a recommendation to DCGI (Drugs Controller General of India) for the use of BharatBiotech's Covaxin for 2-18 year olds," the news agency tweeted.
Subject Expert Committee (SEC) has given a recommendation to DCGI (Drugs Controller General of India) for the use of BharatBiotech's Covaxin for 2-18 year olds: Official sources
— ANI (@ANI) October 12, 2021
The phase-2 and phase-3 trial of the vaccine on children have been completed. Earlier this month, Bharat Biotech had submitted the trial data on Covaxin for children in the 2-18 years age group to the DCGI.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid vaccine Covaxin 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.
(With PTI Inputs)
