Tuesday, August 16, 2022

Bharat Biotech seeks permission from DCGI to conduct Covaxin booster trials in children aged 2 to 18

Hyderabad-based pharma business Bharat Biotech has applied to the Drugs Controller General of India (DCGI) for approval to conduct trials of Covaxin as a COVID-19 vaccine booster dosage in the 2-18 age group.

The corporation submitted an application for permission around a week ago. It has previously done two doses of Covaxin studies in children aged 2 to 18.

Bharat Biotech was recently granted an Emergency Use Authorisation (EUA) for two dosages in youngsters aged 6 to 12.

The pharma company has also applied for the EUA for children aged 2 to 5, but the Subject Expert Committee (SEC) has requested additional information.

Bharat Biotech is the first firm in India to apply to the DCGI for approval to perform booster dosage trials in children aged 2 to 18.

Covaxin is currently included in the national COVID immunization programme for those aged 15 to 18 years old for two doses and those aged 18 to 18 years old for a prophylactic dose.

However, the data collection process for the age range above 18 years is complete for Bharat Biotech’s intranasal booster studies on a heterologous group.

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