Expert panel gives nod to Bharat Biotech's Covaxin jab for kids aged 12-18 years
Highlights
- Bharat Biotech received approval for emergency use authorization of Covaxin for kids aged 12-18
- Covaxin is now the second vaccine cleared for use for children in India.
- In August, DCGI gave approval for emergency-use authorization of Zydus Cadila's ZyCoV-D vaccine.
Bharat Biotech on Saturday received approval for emergency use authorization of the Covaxin Covid-19 vaccine for children in the 12-18 years age group by the Drug Controller General of India (DGCI), said authorities.
Covaxin is now the second vaccine cleared for use for children in India. In August, The Drugs Controller General of India (DCGI) gave approval for emergency-use authorization of Zydus Cadila's ZyCoV-D vaccine, the Union Ministry of Science and Technology said. The world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 will be administered in humans including children and adults 12 years and above, the ministry said.
"... 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.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covaxin for use among those aged between 2 and 18 years, 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."
The DCGI on September 1 granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trial of its made in India COVID-19 vaccine on children and adolescents aged between 5 and 18 years with certain conditions. In July, it had granted permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.
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