Drug Controller General of India (DGCI) recommends Emergency Use Authorisation (EUA) for the Hyderabad-based Bharat Biotech's Covaxin for children under the age group of 2-18 years. Covaxin is all set to become the first covid-19 vaccine worldwide to be used for vaccinating children as young as 2 years old.
The Subject Expert Committee (SEC) of the drug regulator has recommended granting an emergency use Authorisation to Bharat Biotech's Covaxin for children between the age group of 2-18 on Tuesday.
"After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation," said the expert panel.
Bharat Biotech had last week submitted phase2/3 clinical trials data of children's trials to the DGCI for its verification and subsequent approval for emergency use authorization (EUA) for the jab. Bharat Biotech had submitted the clinical trial data which was reviewed by the Central Drugs Standard Control Organisation (CDSCO) and SEC.
"This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DGCI, Subject Experts Committee, 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," the vaccine developer said.