New Delhi: The first nasal vaccine for COVID-19 developed by Bharat Biotech has received regulatory approval for Phase II and III clinical trials. The Department of Biotechnology (DBT) gave this information on Friday. DBT said the Phase I clinical trial in the age group of 18 years to 60 years has been completed.
“Bharat Biotech’s nasal (intranasal) vaccine is the first nasal vaccine to have received regulatory approval for Phase II and III trials,” it said. This is the first such Covid-19 vaccine that will have clinical trials on humans in India. The vaccine is BBV154, the technology of which was acquired by Bharat Biotech from Washington University.
DBT said, “The company has informed that the vaccine doses administered to healthy participants in Phase I clinical trials have been well accepted by the body. No serious adverse effects are known.” The vaccine was found to be safe even in pre-clinical studies. In animal studies, the vaccine was successful in producing high levels of antibodies.
