Bharat Biotech on Thursday said its COVID-19 vaccine 'Covaxin' has proven to be safe, well-tolerated and immunogenic in 2-18 years old volunteers in phase 2/3 study, reported news agency ANI.
Last week, the Drugs Controller General of India (DCGI) granted emergency use authorisation to indigenously-developed Bharat Biotech's Covaxin for children above 12 years with certain conditions.
"... Based on the recommendations of SEC experts and submission of additional safety data, this directorate has no objection at this stage for additional indication of Whole Virion inactivated corona virus vaccine for use in age group of more than 12 years to 18 years with the dose schedule of 0 and 28 days for restricted use in emergency situation with the condition to submit SmPC, PI, Factsheet incorporating clinical information for said age group along with pharmacovigilance & risk management plan," the DCGI approval order issued said.
Earlier, Bharat Biotech had completed the phase 2/3 trials of Covaxin for use among those aged between 2 and 18 years. It had submitted the data to CDSCO for its verification and subsequent approval for emergency use authorisation EUA for the jab in the beginning of October.
It had presented its proposal for grant of market authorisation of its Whole Virion, Inactivated coronavirus Vaccine (BBV152) in the 2 to 18 years age group for restricted use in emergency situation along with the interim safety and immunogenicity data of phase 2/3 clinical trial conducted.
Reacting to the development, Bharat Biotech in a statement said, "Covaxin is formulated uniquely such that the same dosage can be administered to adults and children. Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. We have documented excellent safety and immunogenicity data readouts in children. We look forward for Covaxin to provide similar levels of protection for adults and children alike."
Meanwhile, vaccination for children between 15-18 years will start from January 3.
(With PTI inputs)
