The expert panel of the central drug regulator has recommended that Bharat Biotech's Covaxin be given marketing authorization with conditions for restricted emergency use (EUA) in children and adolescents aged two to eighteen years.
But, top government sources stated on Tuesday that the ultimate approval of EUA from the drug authority and inclusion of the vaccine in the national Covid vaccination program for the pediatric population will take a few more days since data supplied by the company will be further scrutinized.
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"Only a portion of the subject expert committee's (SEC) recommendation for EUA for Covaxin was accepted. The recommendations come with a slew of conditions. "We're currently evaluating the application and won't have a final decision for a few more days," a top regulatory official said.
The National Technical Advisory Group on Immunisation (NTAGI) for Covid-19 will assess the data after the Drugs Controller General of India gives final regulatory approval for Covaxin for restricted emergency use in the 2-18 age group.