Bharat Biotech, on September 23, said it had entered into a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp-adenovirus, single dose intranasal vaccine for COVID-19.
Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe.
While the Phase I trials will take place in St. Louis University’s Vaccine & Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP facility located in Genome Valley, Hyderabad.
An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive.
"We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals vaccinated receiving a single-dose regimen," said Krishna Ella, Chairman and Managing Director - 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 to be involved in diverse but tenable projects to provide a much-needed vaccine against COVID-19 reaches all citizens of the world,” Ella added.
The intranasal vaccine candidate has shown unprecedented levels of protection in mice studies; the technology and data having been recently published in the prestigious scientific journal Cell and in an editorial in Nature.
“The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration," said Dr. David T. Curiel, MD, Ph.D., Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis and Precision Virologics Interim CEO said,
"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,” Curiel added.
This vaccine expands Bharat’s portfolio of vaccines that are currently being developed and are in various stages of clinical development including Covaxin which is currently in Phase II human clinical trials in India.