NEW DELHI, Aug 13: Bharat Biotech’s BBV154 intranasal vaccine has received the regulatory approval for Phase 2/3 trials, a spokesman for the Union Ministry of Science and Technology said on Friday. It is the first vaccine of its kind to receive the nod for further trials.
“This is the first of its kind COVID-19 jab to undergo human clinical trials in India. BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. The Company has in-licensed technology from Washington University in St Louis, USA,” the spokesman said.
The development of the vaccine was supported by the Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC).
As per information released by the Ministry, Phase 1 Clinical trial has been completed in age groups ranging ≥18 to ≤60 years.
“The Company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, has been well tolerated. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies,” the spokesman said.
Renu Swarup, Secretary, DBT and Chairperson, BIRAC, said the department, through Mission COVID Suraksha, was committed to developing safe and efficacious COVID-19 vaccines.
(Manas Dasgupta)