Bharat Biotech’s Covaxin is all set to emerge as the first Covid-19 vaccine globally to be used for vaccinating children as young as 2 years old with the subject expert committee (SEC) that advises the Drugs Controller General of India (DCGI) recommending emergency use authorisation (EUA) for the vaccine for kids in the 2-18 years age group.
The company, in a statement issued on Tuesday, said it had 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 SEC have provided their positive recommendations,” the company said.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, SEC and 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,” Bharat Biotech said.