Bharat Biotech Seeks DCGI’s Permission To Conduct Covaxin Booster Trials In 2-18 Age Group

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.

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. (ANI)