Bharat Biotech's BBV154 Covid vaccine elicited high level of antibodies in animal studies.
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.
BIRAC Chairperson Dr Renu Swarup, who is also Secretary with the department, said that "the department, through Mission COVID Suraksha, is committed to development of safe and efficacious COVID-19 vaccines".
Mission COVID Suraksha was launched to reinforce and accelerate COVID-19 vaccine development efforts as part of the third stimulus package, Atmanirbhar 3.0, the PIB release said. Its focus is to consolidate and streamline available resources towards accelerated vaccine development.
Hyderabad-based Bharat Biotech, on the other hand, has till now delivered over four billion doses of vaccines worldwide. Its Covaxin, developed in partnership with the Indian Council of Medical Research, was one of the two vaccines India used to launch its massive nationwide Covid inoculation programme earlier this year.