The Drug Controller General of India (DCGI) licenced Covaxin, a COVID-19 vaccine developed by Bharat Biotech, for emergency use on children aged 12 to 18. The vaccine is not recommended for children under the age of 12. India will begin distributing immunizations to youngsters aged 15 to 18 years old on January 3. After Zydus Cadila's ZyCoV-D, a three-dose DNA vaccine, Covaxin is the second vaccination approved for use on children in India. Covaxin comes in two doses.
In October, Bharat Biotech submitted data from Covaxin clinical studies in the 12-18 year old age group to the Central Drugs Standard Control Organisation (CDSCO).
"This Directorate took into account the recommendations of SEC experts. As a result, this Directorate has no objections at this time to the additional indication of Whole Virion inactivated Corona Virus Vaccine for use in Kids in the age group between 12 to 18 years for restricted use in an emergency situation, based on the recommendations of SEC experts and the submission of additional safety data "According to the DCGI letter to Bharat Biotech,
Bharat Biotech said in an official statement after receiving the DCGI approval, "Covaxin is made in such a way that it can be given to both adults and children at the same time. The original variation, as well as later variants, have a track record of safety and efficacy in adults."
The DCGI approved trials for the third vaccine, Serum Institute's Novavax, for children aged seven to eleven years old last month. Corbevax, a vaccine developed by Biological E, has been approved for advanced testing on children over the age of five.