"Bharat Biotech's intranasal 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 intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine. BBIL has in-licensed technology from Washington University in St Louis, USA," a Ministry of Science & Technology statement said.
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 trial have been well tolerated, and no serious adverse events were 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.
The regulatory approval has been received for conducting "Phase 2 randomised, multi-centric, clinical trial of heterologous 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.
Secretary, Biotechnology and BIRAC Chairperson, Dr Renu Swarup, 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."