NEW DELHI, Oct 12:
An expert panel of India’s Central drug authority has recommended granting emergency use authorisation to Bharat Biotech’s Covaxin for children and adolescents in the 2 to 18 years age group with certain conditions, sources said today.
If approved by the Drugs Controller General of India (DCGI), it will be the second COVID-19 vaccine after Zydus Cadila’s needle-free ZyCoV-D to receive EUA for use in those below 18 years.
Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month.
The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application on Monday.
“After detailed deliberation, the committee recommended grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in emergency situations subject to the certain conditions,” the SEC recommendations stated.
The recommendations have been forwarded to the DCGI for final approval.
If approved by DCGI, it will be the second vaccine after Zydus Cadila’s needle-free COVID-19 vaccine ZyCoV-D to receive EUA for use in those below 18 years.(PTI)
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