The Subject Expert Committee (SEC) on Covid-19 has granted emergency use authorisation to the Bharat Biotech’s Covaxin for children aged 2 to 18 years. The SEC has submitted its recommendation to the Drugs Controller General of India (DCGI) for final approval.
The expert panel of the drug regulator said in a statement that “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”.
SEC further added that “the developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol”.
However, this emergency use authorization is subjected to certain conditions. The updated prescribing information, package insert, summary of the product charectoristics, and factsheets shall be provided later. Bharat Biotech shall submit the safety data as per the requirements of the New Drugs & Clinical Trials Rules, 2019 soon.
Meanwhile, World Health Organization (WHO) is yet to grant emergency use authorization to Covaxin. On July 9, Bharat Biotech had submitted all the required documents required for the listing to the WHO and they are under review process.
Earlier in August, India had granted emergency use approval to ZyCov-D’s Covid-19 vaccine for use in children 2-18 years. The vaccine was developed by Zydus, a pharmaceutical and is the first DNA vaccine to be approved in the world.