In a major step to further the expanse of the vaccination drive in the country, Subject Expert Committee (SEC) of the drug regulator has recommended granting an emergency use authorisation to Bharat Biotech’s Covaxin for children aged between 2-18. For the final approval, SEC has submitted its recommendation to the Drugs Controller General of India (DCGI).
SEC in its statement stated, “After detailed deliberation, the committee recommended the grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation”. SEC further added, the emergency use authorisation is subject to four conditions.”The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.”
Other conditions stated by the expert panel include includes: the firm should provide updated Prescribing Information/Package Insert (PI), Summary of Product Characteristics (SmPC) and Factsheet; the firm should submit safety data, including the data on AEFI and AESI, with due analysis, every 15 days for the first two months and monthly thereafter and also as per requirement of New Drugs & Clinical Trials Rules, 2019; and the firm should submit risk management plan.
Bharat Biotech in their statement shared that this is one of the first approvals worldwide for COVID-19 vaccines for the age group 2-18.”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,” the statement said. For Age group 2-18, there will be a gap of 28 days for two doses of vaccine, and for adults the gap is for 4-6 weeks.
Before Bharat Biotech’s Covaxin, DGCI had given approval to ZyCoV-D for children aged 12 and above as well as adults in August. Covaxin is the second vaccine approved for children in India.