SunstarTV Bureau: The subject expert committee on Covid-19 has granted an emergency use approval to Bharat Biotech’s Covaxin for children in the 2-18 years age group.
Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of this month.
“After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of >2 to the made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.
The emergency use authorisation, however, is subject to certain conditions. The developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine the approved clinical trial protocol.
It will have to provide updated prescribing information/package Insert (PI), Summary of Product Characteristics (SmPC) and factsheet.
Moreover, 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, it said.
Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin. Bharat Biotech had reportedly submitted all documents required for the listing to the WHO by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.
