By: IPP Bureau
Last updated : December 27, 2021 9:56 am
Covaxin is formulated uniquely such that the same dosage can be administered to adults and children
Bharat Biotech's Covid-19 vaccine Covaxin has been approved for emergency use on children between the ages of 12 and 18 by the Drugs Controller General of India (DCGI).
"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.
Bharat Biotech in a statement said that “Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. We have documented excellent safety and immunogenicity data readouts in children.