The Subject Expert Committee (SEC) has given a recommendation to Drugs Controller General of India (DGCI) for the use of Bharat Biotech’s Covaxin for 2-18-year-olds.
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 DCGI.
“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 emergency situation,” 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.
This makes Covaxin only the second vaccine to be approved for children in India, and the first ever in the world to be approved for children below the ages of 12.
In a statement, Bharat Biotech said the clinical trial data it had submitted was thoroughly reviewed by the Central Drugs Standard Control Organisation (CDSCO) and SEC, who provided their positive recommendations.
“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,” the vaccine developer said.
“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 SEC expert panel said in a statement.
It said that the emergency use authorisation, however, is subject to 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 requirement of New Drugs & Clinical Trials Rules, 2019; and the firm should submit risk management plan.
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.
(Agencies; Picture Courtesy: PTI)