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Bharat Biotech's Covaxin gets expert panel's nod for children above 2 years

Bharat Biotech’s Covaxin will become the world’s first Covid-19 vaccine approved for use in children as young as 2 years. The expert panel advising India’s drug regulator on Tuesday recommended granting emergency use authorisation to the vaccine for children in the 2-18 years age group. The Hyderabad-based company has been asked to submit data on any adverse event following vaccination every 15 days for the next two months. It has also been told to update the package inserts, fact sheet, and summary of product characteristics for its vaccine pack. Bharat Biotech said it was awaiting further regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) before the company could launch the product for children. The Subject Expert Committee (SEC) has submitted its recommendation to the drug regulator, and a formal approval from the Drugs Controller General of India (DCGI) is expected after he examines the data and the recommendation.

News Source:- https://www.business-standard.com/article/current-affairs/drug-authority-s-expert-panel-green-signals-covaxin-for-kids-aged-2-18-yrs-121101201145_1.html