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Bharat Biotech’s Covid nasal vaccine gets regulator’s nod for holding phase 2, 3 trials

The first nasal COVID-19 vaccine developed by Bharat Biotech has got regulatory approval for phase second and third trials. This is the first of its kind COVID-19 jab to undergo human clinical trials in India.   The Department of Biotechnology said the phase one Clinical trial has been completed in the age groups ranging  18 to 60 years. The Company reports that the doses of the vaccine administered to healthy volunteers in this phase has been well tolerated and no serious adverse events have been reported. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies.  The Department said the vaccine was able to elicit high level of neutralizing antibodies in animal studies.

Secretary, Department of Biotechnology, Dr. Renu Swarup, said that the Department through Mission COVID Suraksha is committed to development of safe and efficacious COVID-19 vaccines.

 

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