New Delhi: The first nasal vaccine against Covid-19 has been developed by Bharat Biotech. It has received regulator’s nod for conducting phase 2 and 3 clinical trials, the Department of Biotechnology (DBT) said Friday. The phase 1 clinical trial of the Bharat Biotech nasal vaccine has been completed in age groups ranging from 18 to 60 years, 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.
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’, the DBT said. This is the first of its kind Covid-19 vaccine to undergo human clinical trials in India, it added.
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, the DBT informed.
“The company reports 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,” the DBT said.
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 neutralising antibodies in animal studies, it added.