Big Announcement: Covaxin gets emergency use approval for kids aged 2-18 years
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Bharat Biotech’s Covaxin was granted restricted emergency use approval in ‘clinical trial mode’ on January 2.
The Subject Expert Committee (SEC) of the drug regulator has recommended granting an emergency use authorisation to Bharat Biotech’s Covaxin for children 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 expert panel said in a statement.
The SEC has submitted its recommendation to the Drugs Controller General of India.
Bharat Biotech had recently submitted Phase 2/3 clinical trials data of children’s trials to the DCGI.
Two doses of Covaxin are likely to be administered to children with a gap of 28 days. For adults, the government has set a gap of 4-6 weeks between the two shots.
This is the second COVID-19 vaccine to get approved for children in India.
The drugs regulator had earlier approved ZyCoV-D for children aged 12 and above as well as adults. However, the rollout has not yet begun.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing COVID-19 vaccination drive.