Bharat Biotech's 1st Nasal Covid Vaccine Gets Phase 2/3 Trial Nod

Bharat Biotech's intranasal vaccine against Covid was found to be safe during phase 1 trials.

Bharat Biotech has received phase 2/3 human clinical trial nod for its nasal Covid vaccine, BBV154, the Union government informed today. Phase 1 showed that its doses were "well tolerated" and with no serious "adverse event" reported, it said. This intranasal vaccine is the first to receive the Biotechnology Industry Research Assistance Council's (BIRAC) approval for late-stage clinical trials, a Press Information Bureau release said. "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," it said. BIRAC is a not-for-profit public sector enterprise set up by the Department of Biotechnology under the Union Ministry of Science & Technology. It is an "interface agency to strengthen and empower" emerging biotech enterprises to undertake strategic research and innovation.