Bharat Biotech seeks DCGI's permission to conduct Covaxin booster trials in 2-18 age group

New Delhi [India]: Hyderabad-based pharma company Bharat Biotech has sought permission from the Drugs Controller General of India (DCGI) to conduct trials of Covaxin as COVID-19 vaccine booster dose in the 2-18 age group, sources said.

The company has applied for permission a week ago. It has already conducted trials in the age group of 2-18 for two doses of Covaxin.

Recently, Bharat Biotech has also received an Emergency Use Authorisation (EUA) approval for 6-12 years old children for two doses.

Bharat Biotech has also applied for the EUA for the 2-5 years old but Subject Expert Committee (SEC) has asked for more data.

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Bharat Biotech is the first company in India who had applied for permission from DCGI to conduct trials of a booster dose in the 2-18 age group.

Currently, the Covaxin is under the national COVID vaccination programme for the above 15-18 age group for two doses and above 18 years old for a precaution dose.

The trials for Bharat Biotech's intranasal booster on a heterologous group are under trial, according to the sources data collection process is over for the age group above 18 years.