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Covaxin cleared for kids aged 6 to 12 years

Bharat Biotech asked to keep submitting safety data

Covaxin cleared for kids aged 6 to 12 years

As India once again sees an uptick in Covid-19 cases, the Drugs Controller General of India granted restricted emergency use authorisation to Bharat Biotech's Covaxin for children aged 6 to 12 years on Tuesday.

The panel had approved Covaxin for emergency use in children above 12 years in December 2021.

On vaccination of 6-12 year-olds, the company has been asked to submit safety data, including that on adverse events, with due analysis every 15 days for the first two months and monthly thereafter for five months.

On April 21, the Subject Expert Committee (SEC) of DCGI had asked Bharat Biotech to provide additional data on administration of Covaxin for kids in the 2-12 years age group.

At the time, the panel recommended granting emergency use authorisation to Biological E's Covid-19 vaccine Corbevax for children in the five to 11 years age group.

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