Bharat Biotech seeks DCGI's nod to conduct Covaxin booster trials on kids
New Delhi, May 4: Bharat Biotech, a Hyderabad-based drug manufacturer, has sought the Drugs Controller General of India's (DCGI) approval to conduct trials of Covaxin as a Covid-19 vaccine booster dose in children aged 2 to 18, according to sources.
The firm has applied for permission a week ago, while it has already conducted trials in the age group of 2-18 for two doses of Covaxin.
Bharat Biotech was recently granted an Emergency Use Authorisation (EUA) for two doses in children aged 6 to 12.
The firm has also applied for the EUA for children aged 2 to 5, but the Subject Expert Committee (SEC) has sought additional details.
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Bharat Biotech is the first company in India to apply to the DCGI for approval to conduct booster dose trials in children aged 2 to 18.
Covaxin is currently included in the national Covid vaccination programme for those aged 15 to 18 years old for two doses and those aged above 18 for a precaution dose.
According to sources, the data collection process for the age group above 18 years is completed for Bharat Biotech's intranasal booster trials on a heterologous group.
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-PTC News
