An expert panel on Tuesday granted emergency use approval (EUA) to Bharat Biotech’s Covaxin for children between the ages of two and 18, news agency ANI said.
Final approval for the use of the vaccine on children will be given by the Drug Controller General of India.
“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 source,” news agency ANI tweeted
“After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” the SEC said in a statement.
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The EUA, however, is subject to certain conditions. “The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol,” the SEC said.
Hyderabad-based Bharat Biotech had completed Phase 2/3 trials of Covaxin on children below 18 years of age in September and submitted the data to the DCGI at the start of this month.
Two doses of the vaccine are likely to be administered to children with a gap of 28 days. For adults, the government has set a gap of four to six weeks.
Dr Sanjay K Rai, a professor at Centre for Community Medicine, All India Institute of Medical Sciences, has told ANI that the latest trials show that the safety and immunogenicity of Covaxin are almost the same in children as adults above 18 years of age.