Bharat Biotech’s intra-nasal COVID vaccine gets DCGI nod for phase-II and -III trials

The first nasal vaccine against COVID-19, developed by Bharat Biotech, has received the DCGI’s nod for conducting phase-II and -III clinical trials, the Department of Biotechnology (DBT) said recently. Phase-I clinical trial has been completed in age groups ranging from 18 to 60 years, it said.

“Bharat Biotech’s intra-nasal vaccine is the first nasal vaccine that has received the regulatory approval for phase II/III trials,” the DBT said.

The regulatory approval has been received for conducting “a phase-II randomised and 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 intra-nasal COVID-19 vaccine) in healthy volunteers.”

This is the first-of-its-kind COVID-19 jab to undergo human clinical trials in India, it said.

BBV154 is an intra-nasal replication-deficient chimpanzee adenovirus SARS-CoV-2-vectored vaccine.

Bharat Biotech has in-licensed technology from the Washington University in St Louis, the US, it said. “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,” the DBT 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 a high level of neutralising antibodies in animal studies, it added.

The Mission COVID Suraksha was launched to accelerate COVID-19 vaccine development efforts as part of the third stimulus package, Aatmanirbhar 3.0.

The focus of this mission is to consolidate and streamline available resources towards a warpath for accelerated vaccine development in order to bring a safe, efficacious, affordable and accessible COVID-19 vaccine to the citizens at the earliest. “The department, through Mission COVID Suraksha, is committed to the development of safe and efficacious COVID-19 vaccines. Bharat Biotech’s BBV154 COVID vaccine is the first intra-nasal vaccine being developed in the country entering into late-stage clinical trials,” Renu Swarup, Secretary, DBT and Chairperson, BIRAC said.