Bharat Biotech seeks DCGI nod for phase 2/3 Covaxin booster trial among two to 18-yr-old
BHARAT Biotech has sought permission from India’s drug regulator to conduct a
phase 2/3 study of its COVID vaccine Covaxin as a booster dose among those agedtwo to 18 years, sources told PTI.
Presently, precaution dose of Covaxin and Covishield is administered to all those aged above 18 who have completed nine months after the second dose.
“The Hyderabad-based firm had on April 29 submitted an application to DCGI seeking permission to conduct phase 2/3 trial to evaluate the safety, reactogenicity and immunogenicity of Covaxin as a booster dose in healthy volunteers aged 2 to 18 years,” a source in the know of the developments told PTI.