Covaxin gets emergency use approval for kids aged 2-18 years
For final clearance, the recommendations have been sent to the Drugs Controller General of India (DCGI).
An expert panel of India’s Central Drug Authority has recommended that Bharat Biotech’s Covaxin be given emergency use authorization for children aged 2 to 18 with specified illnesses.
Earlier this month, Hyderabad-based Bharat Biotech submitted the data from phase 2/3 trials of Covid vaccine Covaxin for use in children aged 2 to 18 years to the Central Drugs Standard Control Organisation (CDSCO) for verification and subsequent approval for emergency use authorisation (EUA) for the jab.
The Covid-19 Subject Expert Committee (SEC) evaluated the data and deliberated on the EUA application.
The SEC noted in its recommendations,” Following extensive consideration, the committee recommended that the vaccine be granted market authorisation for the age category of 2 to 18 years for restricted use in emergency cases subject to certain criteria.”
For final clearance, the recommendations have been sent to the Drugs Controller General of India (DCGI).