The data for Bharat Biotech’s Covaxin for Children, the vaccine against coronavirus disease (Covid-19) for children, is under evaluation and the process would more time for final approval from the Drugs Controller General of India (DCGI), officials familiar with the development said on Monday.
“It’s a sensitive matter. Data evaluation is underway. More data has been submitted,” the official told news agency ANI.
The subject expert committee (SEC) had recently given a recommendation to the DCGI for the use of Bharat Biotech’s Covaxin Covid-19 vaccine for the beneficiaries in the age group of 2–18 years. The DCGI will give its final approval after evaluating the data.
Covaxin’s efficacy among children was found to be similar to that in adults but a decision on its inclusion in the national vaccination programme was yet to be taken.
Bharat Biotech said in an official statement earlier that they are waiting for further approvals from the drug regulators.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2–18 age group. Bharat Biotech sincerely thanks the DCGI, 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,” a statement by Bharat Biotech read.
Bharat Biotech had submitted data from clinical trials in the 2–18 years age group for Covaxin (BBV152) to Central Drugs Standard Control Organisation (CDSCO), ANI reported.
The data has been thoroughly reviewed by the CDSCO and the SEC and has provided their positive recommendations, the manufacturer of Covaxin said.
“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 subject to the setting conditions,” the Hyderabad-based vaccine manufacturer said.
Earlier on November 3, the World Health Organisation (WHO) had also given Emergency Use Listing (EUL) to Covaxin.
Covaxin is the second Covid-19 vaccine to be approved for emergency use among children in India after Zydus Healthcare’s ZyCoV-D, meant for children above 12 years of age.