Bharat Biotech developed and manufactured COVID-19 vaccine – Covaxin – has been approved for “emergency use” for children aged between 12 and 18 years.
Drugs Controller General of India (DCGI) approved the vaccine for children above 12 years age, under certain ‘conditions’.
Meanwhile, PM Narendra Modi has stated that India will start rolling out vaccines for children in the age group of 15 to 18 years from January 3.
“The recommendations of SEC experts were considered by this Directorate. Accordingly, based on the recommendations of SEC experts and submission of additional safety data, this Directorate has no objection at this stage for the additional indication of Whole Virion inactivated coronavirus vaccine for use in the age group of 12 to 18 years for restricted use in an emergency situation,” the DCGI letter to Bharat Biotech read.
Meanwhile, after receiving the DCGI nod, Bharat Biotech in a statement said: “Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. It has established a proven record for safety and efficacy in adults for the original variant and subsequent variants.”
Covaxin is now the second vaccine cleared for use for children in India.
In August, Zydus Cadila’s three-dose DNA jab was allowed to be used on adults and children over the age of 12.