Hyderabad, Oct 12 (FN Representative) Indigenous Covaxin developed for adults by Bharat Biotech (BB), is waiting for regulatory approvals from the CDSCO (Central Drugs Standard Control Organization) prior to product launch and market availability of Covaxin for Children between the age group of 2-18. Covaxin, indigenously developed by Hyderabad-based BB in collaboration with the Indian Council of Medical Research IICMR), is being used in adults in India. In a statement here on Tuesday, the vaccine maker said that it 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.
This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group, it said. Bharat Biotech sincerely thanks the DCGI (Drugs Controller General of India) , 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, the statement added. If the indigenous vaccine is cleared, it will be administered to children between the age-group of 2-18 and will provide a major boost to the country’s vaccination programme.