Bharat Biotech seeks DCGI nod for phase-II/III Covaxin booster trial
The study is likely to be conducted at six sites, including AIIMS Delhi and Patna
Bharat Biotech has sought permission from India’s drug regulator to conduct a phase-II/III study of its COVID vaccine Covaxin as a booster dose among those aged two to 18 years, sources told PTI.
Currently, precaution dose of Covaxin and Covishield is administered to all those aged above 18 years, who have completed nine months after the second dose.
“The Hyderabad-based firm had on 29th April submitted an application to DCGI seeking permission to conduct phase-II/III trial to evaluate the safety, reactogenicity and immunogenicity of Covaxin as a booster dose in healthy volunteers aged two to 18 years,” a source in the know of the developments told PTI.
The study is likely to be conducted at six sites, including AIIMS Delhi and Patna.
Edits by EP News Bureau