Hyd-based Bharat Biotech's nasal vaccine gets approval for phase II-III trials
Bharat Biotech's intranasal vaccine has received regulatory approval for phase II and III trials. This is a first-of-its-kind COVID-19 jab to undergo human clinical trials in India.
By Newsmeter Network Published on 13 Aug 2021 1:31 PM GMT
Hyderabad: Bharat Biotech's intranasal vaccine has received regulatory approval for phase II and III trials. This is a 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. Bharat Biotech has in-licensed technology from Washington University in St Louis, USA.
Phase I clinical trial has been completed in age groups ranging from 18 to 60 years. The Hyderabad-based company reported that the doses of the vaccine administered to healthy volunteers in Phase I clinical trial has been well-tolerated and no serious adverse events were reported. Previously, the vaccine was found to be safe, immunogenic, and well-tolerated in the preclinical toxicity studies. The vaccine was able to elicit high levels of neutralizing antibodies in animal studies.
The regulatory approval has been received for conducting Phase II randomized, 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.
Dr. Renu Swarup, the secretary, DBT, and chairperson, BIRAC, said, "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."
