The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’sBiotech’s Covaxin for children 2-18 years. In September, Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age 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 authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency,” the subject expert panel said in a statement.
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. Therefore, 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 AEFI and AESI, with due analysis every 15 days for the first two months and months after that. After that, as per New Drugs & Clinical Trials Rules, 2019, it said.
Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin. Bharat Biotech 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.
In August, India had also granted emergency use approval to ZyCov-D’s Covid-19 vaccine for children between the ages of 12 and 18. The vaccine was developed by pharmaceutical firm Zydus Cadila and is the first DNA vaccine to be approved globally.