Bharat Biotech, a leading vaccine and bio-therapeutics manufacturer, has inked a licencing agreement with Washington University School of Medicine in St. Louis, Missouri, the US, for a single dose intranasal vaccine for coronavirus disease (Covid-19).
Bharat Biotech owns the rights to distribute the vaccine in all markets except for the US, Japan and Europe, the company announced on Wednesday.
The phase-I trials, which will check the safety profile of the vaccine candidate in humans, will take place in the US university’s vaccine and treatment evaluation unit in St. Louis.
Upon obtaining the required regulatory approval, Bharat Biotech will pursue further stages of clinical trials in the country and undertake large scale manufacture of the vaccine at its GMP facility located in Genome Valley, Hyderabad.
“We are proud to collaborate on this innovative vaccine. We envision that we will scale this vaccine to one billion doses. Individuals can be vaccinated by a single dose regimen. An intranasal vaccine will not only be simple to administer but also reduce the use of medical consumables such as needles, syringes, etc, significantly impacting the overall cost of a vaccination drive,” said Krishna Ella, chairman and managing director (MD), Bharat Biotech.
“Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines. It is prudent for Bharat Biotech to be involved in diverse but tenable projects to provide a much-needed vaccine against Covid-19 that reaches all citizens of the world,” he added.
According to the company’s statement, this intranasal vaccine candidate has shown unprecedented levels of protection in mice studies; for which the technology and data have been recently published in the scientific journal Cell and in an editorial in Nature, a British weekly scientific journal.
Dr David T Curiel, director, Biologic Therapeutics Center, and professor of radiation oncology at Washington University School of Medicine in St. Louis and Precision Virologics’ interim chief executive officer (CEO) said in a statement, “The ability to accomplish effective immunisation with a single nasal dose is a major advantage, offering broader reach and easier administration. 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.”
The latest move expands Bharat Biotech’s portfolio of vaccines that are being developed and are in various stages of clinical development, including Covaxin, which is in phase-II human clinical trials stage in India.