Bharat Biotech gets regulator's nod to conduct phase 2/3 trial of its nasal COVID-19 vaccine

Bharat Biotech has received the regulator's nod to conduct Phase 2-3 clinical trials of its nasal COVID-19 vaccine candidate, the science and technology ministry said on Friday. "This is the first of its kind COVID-19 jab to undergo human clinical trials in India," the ministry explained.

"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 added.

Bharat Biotech has developed the nasal COVID-19 vaccine candidate with support from the department of biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC).

"They together have strategized to fast-track R & D efforts especially for vaccine development, diagnostics, drug repurposing, therapeutics and testing. The development of vaccines has been the top priority of the Department of Biotechnology," noted the ministry in a press release.

Bharat Biotech has already completed the Phase 1 clinical trials for the nasal COVID-19 vaccine. The trial was conducted on participants in the 18-60 age group. The firm has reported the nasal vaccine doses administered to healthy volunteers during the Phase 1 clinical trial were well tolerated and that no serious adverse events were reported.

Earlier, the nasal vaccine was found to be safe, immunogenic and well-tolerated in pre-clinical toxicity studies, according to the ministry. It was able to elicit a high level of neutralising antibodies in animal studies, noted the ministry.

Bharat Biotech has now been granted approval 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."

Commenting on the approval, Renu Swarup, Secretary, DBT and Chairperson, BIRAC, said, "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".

The government had launched Mission COVID Suraksha in November 2020 to reinforce and accelerate COVID-19 vaccine development efforts.

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