The Drugs Controller General of India has approved Bharat Biotech’s COVID-19 vaccine, Covaxin, for emergency use on children aged 12 to 18. (DCGI). India will begin distributing vaccinations to youngsters aged 15 to 18 years old on January 3, the Prime Minister announced in a speech on Saturday.
Bharat Biotech had submitted earlier data from Covaxin (BBV152) clinical studies in the 2-18-year-old age range to the Central Drugs Standard Control Organization (CDSCO). After discussing Bharat Biotech’s EUA application on October 12, the CDSCO’s Subject Expert Committee on COVID-19 recommended awarding emergency use approval to Covaxin for use in the 12–18 year age range with certain conditions.
The DCGI has approved Bharat Biotech’s Covaxin vaccine for use in the age group of 12 to 18 years for restricted use in an emergency. The recommendations of SEC experts were considered by this directorate. The company stated that Covaxin is formulated uniquely such that the same dosage can be administered to adults and children alike.
Covaxin is just the second vaccination approved for use on children in India; Zydus Cadila’s three-dose DNA vaccine was approved for use on adults and children over the age of 12 in August. The Serum Institute’s Novavax vaccine is a third possible vaccination for children, and the DCGI approved studies for youngsters aged seven to eleven years old last month. A fourth option is Biological E’s Corbevax, which has been approved for use in children over the age of five.