Bharat Biotech's nasal vaccine has received regulatory approval for Phase 2/3 trials, according to information provided by the Department of Biotechnology 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. BBIL has in-licensed technology from Washington University in St Louis, USA.
The vaccine is expected to play a key role stepping up the war against pandemic as it is easy to administer and would accelerate the inoculation drive.
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. 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.
Also read: Zydus seeks govt nod for use of new India-made vaccine as trials have been completed
The regulatory approval has been received for conducting“A Phase 2 randomized, 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.”
The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have have strategized to fast-track R & D efforts vaccine development, diagnostics, drug repurposing, therapeutics and testing, the official statement said.
Dr 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.”
