Bharat Biotech's intranasal vaccine is the first nasal vaccine in the country that has received the regulatory approval for Phase 2/3 trials, the Ministry of Science and Technology said in a statement.
"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," it said.
The phase 1 clinical trial of the vaccine has been completed in age groups ranging 18-60 years. The Company reported 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.
The regulatory approval has been received for conducting “a Phase 2 randomised, 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 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.”
 "A health worker collects a nasal sample for Covid-19 Ag rapid antigen testing at Chakkarpur Community Centre, near DLF Phase 4, in Gurugram")