Vaccine maker Bharat Biotech on Tuesday said that it is awaiting further regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for its Covid-19 vaccine Covaxin for the 2-18 years age group.
However, earlier in morning, the Hyderabad-based pharma major Bharat Biotech's Covaxin said it has got the emergency use approval for children in the age group of 2 to 18 years from the Drugs Controller General of India (DCGA).
Meanwhile, now they claim to have submitted data from clinical trials of the vaccine in the 2-18 years age group to CDSCO.
The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and have given their positive recommendations, the company said.
According to the form, this represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group.
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"Bharat Biotech sincerely thank 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," it said.