Speed Post News Network
New Delhi : Bharat Biotech’s intra-nasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials. This is the first of its kind Covid-19 jab to undergo human clinical trials in India. BBV154 is an intra- nasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. Bharat Biotech International Limited (BBIL) has in-licensed technology from Washington University in St Louis, USA.
Phase 1 Clinical trial has been completed in age groups ranging ≥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 neutralising antibodies in animal studies, according to a PIB release.
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 been at the forefront in the fight against the prevailing global crisis. They together have strategised to fast-track R & D efforts especially for vaccine development, diagnostics, drug repurposing, therapeutics and testing. The development of vaccine has been the top priority of the Department of Biotechnology.
This Mission Covid Suraksha was launched to reinforce and accelerate Covid-19 vaccine development efforts as part of the third stimulus package, Atmanirbhar 3.0. The focus of this mission is to consolidate and streamline available resources towards a war path for accelerated vaccine development in order to bring a safe, efficacious, affordable, and accessible Covid-19 Vaccine to the citizens at the earliest with a focus on Atmanirbhar Bharat.
Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC, speaking on the subject said,“ The Department, through Mission Covid Suraksha, is committed to development of safe and efficacious Covid-19 vaccine. Bharat Biotech’s BBV154 Covid Vaccine is the first intra-nasal vaccine being developed in the country entering into late-stage clinical trials.”