India's first intranasal vaccine, being developed by Bharat Biotech in collaboration with the Department of Biotechnology and its PSU, the Biotechnology Industry Research Assistance Council (BIRAC), on Friday got regulatory approval for Phase 2/3 trials.
"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 from 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 a high level of neutralising antibodies in animal studies.
The regulatory approval has been received for conducting "Phase 2 randomised, multi-centric, clinical trial of the 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."