The Subject Expert Committee (SEC) of the drug regulator granted approval of an emergency use authorization to Covaxin for 2-18 age group.
Bharat Biotech’s Covaxin was granted restricted emergency use approval in ‘clinical trial mode’ on January 2 and this approval the expert panel said in a statement was “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,”
It said that the emergency use authorization, however, is administered under four conditions.
“The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol,” SEC added.
Other conditions listed by the expert panel are: 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 the requirement of New Drugs & Clinical Trials Rules, 2019; and the firm should submit risk management plan.
Of note, COVID-19 vaccines were effective against most SARS-CoV-2 variants. Bharat Biotech had last week submitted Phase 2/3 clinical trials data of children’s trials to the DCGI for its verification and subsequent approval for emergency use authorization (EUA) for the jab.
Bharat Biotech, in a statement, said that this represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group.
“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.
Two doses of Covaxin will be administered to children with a gap of 28 days. For adults, the government has set a gap of 4-6 weeks between the two shots.
Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used on adults in India’s ongoing COVID-19 vaccination drive.
This is the second COVID-19 vaccine to get approved for children in India. DGCI had, in August, approved ZyCoV-D for children aged 12 and above as well as adults. However, the rollout is still yet to begin.