Bharat Biotech’s Covaxin gets emergency situation approval for kids aged 2-18 years

Covaxin Gets Subject Expert Committee'S Nod For
Image Source: PTI(FILE)Covaxin gets Subject Specialist Committee’s nod for administering the drug to kids Bharat

Biotech, which finished the Stage 2/3 trials of COVID-19 vaccine Covaxin for usage in children under 18 years of age recently, has actually gotten the Subject Professional Committee’s nod for administering the drug to kids.

The Hyderabad-based biotechnology business had last week sent the data to the Central Drugs Standard Control Organisation for its confirmation and subsequent approval for Emergency situation Use Authorisation for the jab.

With this, Covaxin ends up being the first COVID-19 vaccine that can be administered to children in India.

On the other hand, the World Health Organisation (WHO) is yet to take a call on approving Emergency Usage Listing (EUL) status for Covaxin. The international health body is most likely to a last call today.

Bharat Biotech has actually been submitting information to WHO on a rolling basis and sent extra information at WHO’s request on September 27. WHO professionals are currently examining this information & & if it attends to all questions raised, the WHO assessment will be settled next week.

According to the WHO, its officials and an independent group of experts are arranged to satisfy today to carry out the risk/benefit evaluation prior to taking a decision on whether to grant Emergency situation Use Listing to Covaxin. The Emergency Usage Listing procedure – done by WHO and the Technical Advisory Group of independent specialists – is centred on determining if a produced item is quality-assured, safe and efficient.

The indigenously developed Bharat Biotech’s Covaxin is among the 6 vaccines that have gotten emergency use authorisation from India’s Drug Regulator and is being used in the across the country anti-COVID-19 inoculation program together with Covishield and Sputnik V.

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Released at Tue, 12 Oct 2021 02:52:21 -0500