Bharat Biotech Covaxin for 2-18 Age Group Gets Nod from SEC for Market Authorisation

Bharat Biotech Covaxin for 2-18 Age Group Gets Nod from SEC for Market Authorisation

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The Subject Expert Committee (SEC) has recommended grant of market authorisation to Bharat Biotech’s Covaxin for children in the 2-18 age group, but with certain riders. The SEC has sent recommendations to the Drugs Controller General of India (DCGI), which is likely to soon give a go-ahead.

Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age in September and submitted the trial data to the DCGI at the start of this month.

Unlike the Covaxin for adults and other Covid-19 vaccines currently being administered that are available in multi-dose vials, the paediatric Covaxin will use a pre-filled syringe or PFS mechanism. Pre-filled syringes are known to have a high-level accuracy, which makes them safer to use. The vaccine dosage for children would be 0.5ml, the same as for adults. However, when administering vaccines to children, the accuracy of the dose is crucial.

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