Bharat Biotech gets nod to conduct phase 3, booster trials of intranasal Covid vaccine

New Delhi, Jan 05: The Subject Experts Committee (SEC) of the Drug Controller General of India (DGCI) has given 'in principle' approval to Bharat Biotech for conduct of 'Phase III superiority study and Phase III booster dose study' for its intranasal COVID vaccine.

Bharat Biotech also manufactures the COVID-19 vaccine Covaxin, which was recently given emergency use authorisation for 12-18 year olds. It will now hold trials for its intranasal vaccine (BBV154).

The company had in August received the Drug Controller General of India's (DCGI's) nod for conducting phase 2 clinical trials of the nasal vaccine.

BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. Bharat Biotech has in-licensed the technology from Washington University in St Louis, the US. The company reports that the doses of the vaccine administered to healthy volunteers in the phase-1 clinical trial have been well tolerated. No serious adverse events were reported, the DBT had said.