The first nasal vaccine against COVID-19, developed by Bharat Biotech, has received regulator’s nod for conducting phase 2 and 3 clinical trials, the Department of Biotechnology said on Friday.
Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years, it said.
The release said the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial were 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," it said.
“Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials," the DBT said.
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.
Bharat Biotech has in-licensed technology from Washington University in St Louis, US.