Bharat Biotech’s Covaxin has received the nod from the Subject Expert Committee (SEC) on Covid-19 for the emergency use approval of the vaccine on 2-18 age groups.
Bharat Biotech has apparently achieved positive results for the phase 2 and phase 3 trials on individuals aged between 2-18.
“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” the statement from SEC read.
While the advised gap between the first and second dose of Covaxin in India is 28 days, it varies for the 2-18 age group.
Two doses of the vaccine need to be administered 20 days apart.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children,” Bharat Biotech stated.