Covaxin Approved By Drugs Controller General of India For Children Aged 2-18 Years

New Delhi: Covaxin has been approved by the Drugs General of India to be administered in children aged between 2 to 18 years. Previously, the vaccine was available only for adults above the age of 19.

This has made Covaxin the second vaccine in India to be approved by the DCGI for children. The first one to be approved by the DCGI was ZyCoV-D which was available for children above the age of 12 in addition to adults.

The Phase-2 and Phase-3 trials of Covaxin had been successfully completed by Bharat Biotech back in September. Children below the age of 18 years old were administered Covaxin doses during the trial. Last week, the data of the trial was presented to the Drugs Controller General of India.

The market permission was granted to Covaxin by the committee after a proper and detailed discussion. However, the vaccine has been approved for restricted use in an emergency for children between 2-18 years of age.

A child will require to administer the Covaxin vaccine in two doses, with a gap of 20 days between the 1st and 2nd doses.

It is noteworthy that Covaxin has still not be given approval for emergency use authorisation by the World Health Organisation (WHO).

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