The Subject Expert Committee (SEC) of the drug regulator has suggested allowing an emergency use authorisation to Bharat Biotech’s Covaxin for children aged between 2-18. The SEC has presented its proposal to the Drugs Controller General of India.
The data of Phase 2/3 clinical trials had been recently presented by Bharat Biotech to the DCGI. Two doses of Covaxin are expected to be distributed to children with a gap of 28 days. The government has set an interval of 4-6 weeks for adults between the two shots.
This is the second COVID-19 vaccine to receive approval for children in India. “After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency situation,” the subject expert panel said in a statement.
However, the emergency use authorisation is subjected to specific circumstances. The developer of Covaxin will maintain the research as per Whole Virion, Inactivated Corona Virus Vaccine, the approved clinical trial protocol. It will have to present updated prescribing information/package Insert (PI), Summary of Product Characteristics (SmPC) and factsheet.
Furthermore, the firm should present safety data, which includes the data on AEFI and AESI, with the due examination every 15 days for the first two months and months after that and as per New Drugs & Clinical Trials Rules, 2019, it said. The drugs regulator had initially recommended ZyCoV-D for children aged 12 and above as well as adults. However, the distribution has not taken place.