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.
“Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials,” the Department of Biotechnology said. This is the first of its kind Covid-19 jab to undergo human clinical trials in India. Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years. The company said that the vaccine administered to healthy volunteers in Phase I clinical trial was well tolerated and no serious adverse events were reported. The intranasal vaccine was found to be safe, immunogenic and well-tolerated in the preclinical toxicity studies and was able to elicit high levels of neutralizing antibodies in animal studies.
Dr Renu Swarup, Secretary, Department of Biotechnology, said “The Department through Mission Covid Suraksha is committed to the 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.”
News Source : DNA