No Covid vaccine for children yet as regulatory approval awaited: Bharat Biotech

By Jasleen Kaur - October 12, 2021 8:10 pm

The Subject Expert Committee (SEC) has given a recommendation to the Drugs Controller General of India (DCGI) for the use of Bharat Biotech's Covid-19 vaccine, Covaxin, for the beneficiaries aged between 2-18 years, the official sources said on Tuesday.

Also read | After banning coal-based power plants in Delhi, Arvind Kejriwal cries 'coal shortage'

Pfizer asks FDA to authorize Covid vaccine for kids ages 5 to 11

After evaluation of the data, the final approval will be given by the Drug Controller General of India (DCGI). Bharat Biotech in an official statement has said they are waiting for further approvals from drug regulators.

"This represents one of the first approvals worldwide for Covid-19 vaccines for children in the 2-18 age group. Bharat Biotech sincerely thanks the DCGI, Subject Experts Committee, and Central Drugs Standard Control Organisation (CDSCO) for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children," stated the statement issued by Bharat Biotech.

Also read | Jammu and Kashmir: Five LeT terrorists killed by security forces in Shopian

This is one of the first worldwide approval for Covid-19 vaccines for the age group of beneficiaries belonging to 2-18 years.

Pfizer seeks authorization to vaccinate kids 5-11: COVID updates

Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for Covaxin (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have provided their positive recommendations, the vaccine maker said. The Subject Expert Committee on Covid-19 examined the data on Monday.

COVID Vaccines For Healthy Kids Will be Available in India by 2022, Says Central Panel Chief

-PTC News