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The Subject Expert Commitee (SEC) of the drug regulator Drugs Controller General of India (DCGI) has recommended emergency use of authorisation (EUA) to Bharat Biotech’s Covaxin for children in the age group of 2–18 years.
“The overall antibody response for the paediatric population is similar to that of the adult population in phase-III efficacy study,” a government official who didn’t wish to be quoted said.
Also see: Covaxin’s policy review completed, technical review coming up: WHO expert group
“There was a detailed discussion by the committee for giving EUA to Bharat Biotech for Covaxin approval for children. After studying all the clinical trial data, the decision was taken,” the official said.
Hyderabad-based Bharat Biotech had presented its proposal for market authorisation of whole virion, inactivated coronavirus vaccine in the age group of 2 to 18 years for restricted use in emergency situation, along with the interim safety and immunogenicity data of phase II and phase III clinical trials conducted in the age group 2–18.
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