Bharat Biotech's Covid-19 nasal vaccine gets regulator's nod for holding phase 2, 3 clinical trials

Hyderabad-based vaccine manufacturer Bharat Biotech’s intranasal vaccine has received regulatory approval for phase-2/3 clinical trials, the outcome of which would decide whether it could be used in India’s Covid-19 vaccination campaign.

"Bharat Biotech's intranasal vaccine (BBV154) is the first nasal vaccine that has received regulatory approval for multi-centre phase 2/3 trials. This is the first of its kind Covid-19 jab to undergo human clinical trials in India,” the Department of Biotechnology that supports the development of the vaccine, said in a statement on Friday.

Known as BBV154, it is an intra-nasal replication-deficient chimpanzee adenovirus SARS-CoV-2 vectored vaccine developed by scientists at Washington University in St Louis, USA. The Indian firm has received a license for commercial development for Indian and a few other markets.

The phase 1 clinical trial, carried out in people belonging to the 18-60 years of age, showed that the vaccine was well tolerated with no reports of any serious adverse events.

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Previously, the vaccine was found to be safe, immunogenic and well-tolerated in the pre-clinical toxicity studies. It also elicited a high level of neutralizing antibodies in animal studies.

“The intranasal vaccine candidate has shown unprecedented levels of protection in mice studies. “The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration,” David T Curiel director of Biologic Therapeutics Center and professor of radiation oncology at Washington University School of Medicine.

“An effective nasal dose not only protects against Covid-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development can’t do that.”

In a statement issued last September Bharat Biotech's stated that the company would produce one billion doses of the intranasal vaccine

“We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals vaccinated receiving a single-dose regimen. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles and syringes significantly impacting the overall cost of a vaccination drive,” said Krishna Ella, Bharat Biotech’s chairman and managing director.

The company claimed it owned the rights to distribute the vaccine in all markets except the USA, Japan and Europe.

"The Department of Biotechnology is committed to the development of safe and efficacious Covid-19 vaccines. Bharat Biotech’s BBV154 is the first intranasal vaccine being developed in the country entering into late-stage clinical trials," said Renu Swarup, secretary, DBT.