Covaxin Update, Dec 26: The Drug Controller General of India (DCGI) on December 25 gave nod to Bharat Biotech’s vaccine, Covaxin, for emergency use for kids aged 12-18 years.
The report added that further regulatory process is being streamlined to make children registrations on the Cowin platform.
India had in August approved Zydus Cadila’s three-dose needle-free vaccine ZyCoV-D, making it the first vaccine to get permission to be administered to children in the age group of 12 to 18 years.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between two and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in early October.
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The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application.
The committee had noted that the interim safety data of the Phase 2/3 clinical trial was reviewed in a meeting on August 26. After detailed deliberation, the committee had recommended the grant of market authorisation of the vaccine for the two to 18 years age group for restricted use in emergency situations subject to certain conditions.
