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DCGI nod for Bharat Biotech's Covid nasal jab Phase 2/3 trial

BBV154 is an intranasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine

Our Bureau, PTI Hyderabad Published 13.08.21, 06:58 PM
Bharat Biotech has in-licensed technology from Washington University in St Louis, US.

Bharat Biotech has in-licensed technology from Washington University in St Louis, US. Getty Images

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.

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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.

The regulatory approval has been received for conducting "a Phase 2 randomised, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN) with BBV154 (Adenoviral Intranasal COVID-19 vaccine) in healthy volunteers".

This is the first of its kind COVID-19 jab to undergo human clinical trials in India, it said.

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, it said.

"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," the DBT said.

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 neutralising antibodies in animal studies, it added.

The Mission COVID Suraksha was launched to accelerate COVID-19 vaccine development efforts as part of the third stimulus package, Atmanirbhar 3.0.

The focus of this mission is to consolidate and streamline available resources towards a warpath for accelerated vaccine development in order to bring a safe, efficacious, affordable and accessible COVID-19 vaccine to the citizens at the earliest.

"The Department through Mission COVID Suraksha, is committed to 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," Renu Swarup, Secretary, DBT and Chairperson, BIRAC said.

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