Bharat Biotech's Covid Nasal Vaccine Gets Regulator's Nod For Holding Phase 2, 3 Clinical Trials

Bharat Biotech's Nasal Vaccine has been approved for the second and third phase of clinical trials.

(File Photo)

New Delhi: The first nasal vaccine developed by Bharat Biotech against Covid-19 has received regulator's nod for conducting second and third phase clinical trials, the Department of Biotechnology said on Friday. In this statement, it is said that the first phase of trials has been conducted on people between the ages of 18 and 60.

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

According to reports, 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".

The nasal vaccine is the first of its kind Coronavirus 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 phase I clinical trial have 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.

In order to boost the COVID-19 vaccine development, Mission COVID Suraksha was launched 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.

(With inputs from PTI)