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Bharat Biotech has received approval from the DCGI to use Covaxin in an emergency situation for children aged 12 to 18.

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Published By:
Peeyush Ghalot
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(Picture: Manorama)

The Drug Controller General of India has approved Covaxin, a vaccine developed by Bharat Biotech, for emergency use in children aged 12 to 18. The regulatory process is being shortened, according to the article, to make it easier for minors to register on the CoWin platform. Covaxin is the second COVID-19 vaccine to receive approval in India for use in children. Hyderabad-based data from phase 2/3 trials of the COVID-19 vaccine Covaxin for use in children aged two to eighteen years was submitted to the Central Drugs Standard Control. Bharat Biotech submitted an emergency use authorization (EUA) to the Central Drugs Standard Control Organization (CDSCO) for verification and approval. The Subject Expert Committee has reviewed the data and considered the EUA application. Following extensive debate, the committee recommended that the vaccine be granted market authorization for the two-to-18-year-old age group for limited use in emergency cases under particular conditions.

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