COVID-19: Covaxin gets emergency use nod for children aged 2-18 years

COVID-19: Covaxin gets emergency use nod for children aged 2-18 years

The pharma regulator’s Subject Expert Committee (SEC) has recommended that Bharat Biotech’s Covaxin be approved for emergency use in children aged 2 to 18.

The SEC has also submitted its proposal for final clearance to the Drugs Controller General of India (DCGI).

“After detailed deliberation; the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years; for restricted use in an emergency situation,” the expert panel said in a statement.

Covaxin is the second Covid-19 vaccine to be authorised for emergency use in children in India, following Zydus Healthcare’s ZyCoV-D, which is intended for children over the age of 12.

 

ALSO READ: WHO expert panel on Covid-19 vaccines to meet today, Covaxin on agenda

 

 

It said that the emergency use authorisation; however, is subject to four conditions.

 

“The developer of Covaxin will continue the study as per Whole Virion; Inactivated Corona Virus Vaccine the approved clinical trial protocol,” SEC added.

The company should provide updated Prescribing Information/Package Insert (PI); Summary of Product Characteristics (SmPC); and Factsheet; the company should submit safety data; including AEFI and AESI data, with due analysis; every 15 days for the first two months and monthly thereafter; as required by the New Drugs and Clinical Trials Rules, 2019; and the company should also submit risk management plan.

About The Author

Osigweh Lilian Oluchi is a graduate of the University of Lagos where she obtained a B.A (Hons) in English, Masters in Public and International affairs (MPIA). Currently works with 1stnews as a Database Manager / Writer. [email protected]

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