Bharat Biotech's 1st nasal COVID vaccine gets approval for phase 2 trial

Phase 1 of the vaccine showed that its doses were "well tolerated" and with no serious "adverse event" reported, it said.

Bharat Biotech's intranasal vaccine is the first nasal vaccine that has received regulatory approval for phase 2 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. BBIL has in-licensed technology from Washington University in St Louis, USA," an official statement from the Union Government said.

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.

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 randomized, multi-centric, Clinical Trial of Heterologous 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.”