Insight Bureau: The Department of Biotechnology said on Friday that the first nasal vaccine against Covid-19, produced by Bharat Biotech, has obtained regulatory approval for Phase 2 and 3 clinical trials. According to the Department of Biotechnology, “Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials.”
The Covid-19 vaccine is the first of its kind to go through human clinical trials in India. A phase one clinical trial with participants ranging in age from 18 to 60 years old has been completed.
According to the firm, the vaccine was well tolerated by healthy volunteers in a Phase I clinical trial, and no major side effects were reported.
In preclinical toxicity tests, the intranasal vaccine was shown to be safe, immunogenic, and well-tolerated, and it was able to elicit significant levels of neutralising antibodies in animal studies.
Dr. Renu Swarup, Secretary of Biotechnology, stated,“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.”