The Drugs Controller General of India (DGCI) has received a recommendation from the Subject Expert Committee (SEC) for the use of Bharat Biotech’s Covaxin in children aged 2 to 18, according to news agency ANI, citing official sources.
“Following extensive consideration, the committee recommended that the vaccine be granted market authorization for the age category of 2 to 18 years for restricted use in emergencies,” according to a statement from the subject expert panel.
In September, Bharat Biotech, a company based in Hyderabad, completed Phase 2 and Phase 3 studies of Covaxin on children under the age of 18.
However, the data has not been made public yet.
Bharat Biotech claimed in a statement that the clinical study data it had filed had been thoroughly evaluated by the Central Drugs Standard Control Organisation (CDSCO) and the SEC, who both gave it a good recommendation.
“This is one of the first Covid-19 vaccinations for children aged 2 to 18 years old to be approved in the globe. Bharat Biotech expresses its gratitude to the DCGI, the Subject Experts Committee, and the CDSCO for completing the review process promptly. Before the product launch and market availability of Covaxin for children, we need to get more regulatory clearances from the CDSCO “According to the vaccine developer.
However, the emergency use authorization is subject to specific restrictions. The study will be continued according to the approved clinical trial protocol for the Whole Virion, Inactivated Corona Virus Vaccine.
It will be required to give updated prescription information in the form of a package insert (PI), a summary of product characteristics (SmPC), and a factsheet.
Furthermore, the company should provide safety data, including AEFI and AESI data, every 15 days for the first two months and then monthly thereafter, according to the New Drugs & Clinical Trials Rules, 2019.