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Bharat Biotech's Nasal Covid Vaccine Gets Regulatory Nod for Phase 2 and 3 Trial

A man rides his motorbike past a parked bus of India's biotechnology company Bharat Biotech outside its office in Hyderabad, India July 3, 2020. REUTERS/Stringer

A man rides his motorbike past a parked bus of India's biotechnology company Bharat Biotech outside its office in Hyderabad, India July 3, 2020. REUTERS/Stringer

Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years.

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.

Phase 1 clinical trial has been completed in age groups ranging from 18 to 60 years, it said.

ALSO READ | Will Bharat Biotech’s Nasal Vaccine be a ‘Game Changer’? Know All About Its Efficacy & How It Works

The release said the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial were 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," it said.

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“Bharat Biotech’s intranasal vaccine is the first nasal vaccine that has received the regulatory approval for Phase 2/3 trials," the DBT said.

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, US.

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first published:August 13, 2021, 19:01 IST