New Delhi: The Drug Controller General of India (DGCI) today approved to conduct the phase 2/3 trials of the nasal vaccine developed by Bharat Biotech.
The intranasal vaccine which is developed by Bharat Biotech and supported by DBT-BIRAC is the first of its kind COVID-19 jab to undergo human clinical trials in India, an official release said.
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.
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 were reported, the statement read.
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 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.”
Dr RenuSwarup, Secretary, DBT and Chairperson, BIRAC speaking on the subject said that “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 intranasal vaccine being developed in the country entering into late-stage clinical trials.”
The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have been at the forefront in the fight against the prevailing global crisis, the release said.
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.