The Subject Expert Committee on Covid19 has granted emergency use approval to Covaxin for children in the 2-18 years age group.
Bharat Biotech, the Hyderabad-based multinational biotechnology company, 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, says a media report.
“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 emergency situation,” the subject expert committee said in a statement.
The indigenous Covid19 vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.
However, the emergency use authorisation is subject to certain conditions.
The developer of Covaxin will continue the study as per the 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, the report said.
The firm will also have to 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.
The World Health Organisation (WHO) is yet to grant emergency use authorisation to Covaxin.
It has been reported that Bharat Biotech submitted all documents required for the listing to the WHO by July 9.