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Covaxin gets emergency use approval from DCGI for children above 12 years

This makes Covaxin the second vaccine cleared for use for children in India.

December 27, 2021

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DCGI CDSCO Regulator Drugs Controller General India — DCGI

Last Updated on December 31, 2023 by The Health Master

Hyderabad : As Omicron cases are surging in the country, the Drugs Controller General of India (DCGI) has given its approval to Bharat Biotech’s C-19 vaccine for kids between 12 and 18 years of age for emergency use, with certain conditions.

This makes Covaxin the second vaccine cleared for use for children in India.

Indian vaccine maker Bharat Biotech said that Covaxin is formulated uniquely such that the same dosage can be administered to adults and children.

Furthermore, they added that Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants.

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“We have documented excellent safety and immunogenicity data readouts in children. We look forward to COVAXIN providing similar levels of protection for adults and children alike, ” the company said.

I thanked the central government, DCGI and NTAGI for their diligent review of all data and for their fastidious approval process.

After deliberating Bharat Biotech’s EUA application, the Subject Expert Committee (SEC) on C-19 of the CDSCO on October 12 recommended granting emergency use approval to Covaxin for use in the 12–18 age group with certain conditions.

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