Bharat Biotech's intranasal vaccine gets regulator nod for Phase 2/3 trials

It is the first nasal vaccine in the country that has received the regulatory approval for late-stage clinical trials

The intranasal vaccine against coronavirus being developed by Bharat Biotech and supported by Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) has got the regulator nod for Phase 2-3 trials.

Bharat Biotech's intranasal vaccine is the first nasal vaccine in the country that has received the regulatory approval for Phase 2/3 trials, the Ministry of Science and Technology said in a statement.

"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.BBIL has in-licensed technology from Washington University in St Louis, USA," it said. 

The phase 1 clinical trial of the vaccine has been completed in age groups ranging 18-60 years. The Company reported that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, has been well tolerated. No serious adverse events reported. 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 regulatory approval has been received for conducting “a Phase 2 randomised, multi-centric, clinical trial of heterologus prime-boost combination of SARS-CoV-2 vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154 (Adenoviral Intranasal Covid-19 vaccine) in Healthy Volunteers.”

Dr RenuSwarup, Secretary, DBT and Chairperson, BIRAC speaking on the subject said that “the Department through mission Covid Suraksha, is committed to development of safe and efficacious Covid-19 vaccines. Bharat Biotech’s BBV154 Covid vaccine is the first intranasal vaccine being developed in the country entering into late-stage clinical trials.”