Bharat Biotech’s nasal COVID-19 vaccine gets nod for phase 2/3 trial

Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years, it said.

Bharat Biotech’s intranasal vaccine has become the first nasal vaccine to receive the regulatory approval for Phase 2/3 trials, according to a release issued by the Ministry of Science and Technology on Friday.

“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,” said the release.

It added that the development of the vaccine is supported by 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 from 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,” noted the release.

Renu Swarup, Secretary, DBT and Chairperson, BIRAC 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.

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