Expert panel approves Bharat Biotech’s Covaxin jab for 12-18 year olds
Highlight
- Bharat Biotech gets approval for emergency use authorization of Covaxin for children in the age group of 12-18 years
- Covaxin is now the second vaccine approved for use in children in India.
- In August, DCGI approved emergency-use authorization of Zydus Cadila’s ZyCoV-D vaccine.
Bharat Biotech on Saturday got approval for emergency use authorization of Covaxin Covid-19 vaccine for children in the age group of 12-18 years by the Drug Controller General of India (DGCI), officials said.
Covaxin is now the second vaccine approved for use in children in India. In August, the Drug Controller General of India (DCGI) approved the 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 12 years and above, including children and adults, the ministry said.
“…Based on the recommendations of SEC experts and the submission of additional safety data, this Directorate has no objection to additional indications of Whole Virion Inactivated Corona Virus Vaccine for use in the age group 12 years to over 18 years at this stage.” Includes clinical information for the said age group along with pharmacovigilance and risk management plan with condition of submission of SMPC, PI, factsheet along with dosage schedule of 0 and 28 days for restricted use in emergency situation “DCGI approval order issued.
Hyderabad-based Bharat Biotech, which completed Phase 2/3 trials of Covaxin for use among people aged 2 to 18 years, initially sent the emergency use authorization for the jab to the CDSCO for validation and subsequent approval. data was presented. of October.
It submitted its proposal for the grant of market authorization of its complete virion, inactivated coronavirus vaccine (BBV152) in the age group of 2 to 18 years for restricted use in an emergency with interim safety and immunogenicity data from the Phase 2/3 clinical trial. was presented. operated.
Reacting to the development, Bharat Biotech said in a statement, “Covaxin has been uniquely designed to provide the same dosage for adults and children. Covaxin has improved safety in adults for the original version and subsequent variants.” and have established a proven record for efficacy. We have documented excellent safety and immunogenicity data readouts in children. We look forward to Covaxin providing a similar level of protection for adults and children.”
DCGI on September 1 allowed Hyderabad-based Biologicals E Ltd to conduct Phase 2/3 clinical trials of its Made in India COVID-19 vaccine on children and adolescents aged 5 to 18 years with certain conditions. In July, it permitted the Serum Institute of India (SII) to conduct a phase 2/3 trial of Kovovax on children aged 2 to 17 years with certain conditions.
Read also | Bharat Biotech to start exporting Covaxin to additional countries from December
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