India's first nasal vaccine for COVID-19 receives nod for Ph 2/3 trial
13 August 2021 | News
Being developed by Bharat Biotech
image credit- shutterstock
Bharat Biotech's intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials.
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, USA.
Phase 1 Clinical trial has been completed in age groups ranging ≥18 to ≤60 years. 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.
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.
