Bharat Biotech to manufacture and distribute COVID-19 vaccine developed in US

Phase one trials that test for safety and immunogenicity will take place in the US

HEALTH-CORONAVIRUS/OXFORD-VACCINE

Hyderabad-based Bharat Biotech will collaborate with the Washington University School of Medicine in Saint Louis, US, for a novel chimp-adenovirus— a single dose intranasal vaccine for COVID-19. Under the licensing agreement that the company has signed with Bharat Biotech, while phase one trials for the vaccine that test for safety and immunogenicity will take place in the US, further trials and large scale manufacturing of the vaccine will be undertaken in India, after obtaining "regulatory approvals".

"Bharat Biotech owns the rights to distribute the vaccine in all markets except the USA, Japan and Europe," the company said in a statement. Bharat Biotech is also developing COVAXIN, the indigenous vaccine against COVID-19 with ICMR. The vaccine is currently undergoing phase 2 trials in India, according to the company.

About 60-70 per cent of the world's vaccines are made in India, and the case of COVID-19 vaccines may be no different.

"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, syringes, etc., significantly impacting the overall cost of a vaccination drive," Dr. Krishna Ella, chairman and managing director of Bharat Biotech, said in a statement.

"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 which 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', Bharat Biotech said in the statement.

Dr. David T. Curiel, director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis, said the ability to accomplish effective immunization with a single nasal dose is a "major advantage", offering "broader reach and easier administration". "An effective nasal dose not only protect 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," said Curiel, also interim CEO for Precision Virologics. Precision Virologics is a vaccine company developing advanced generation adenoviral vaccines. Its lead agent is a potency enhanced simian adenovirus-based COVID-19 vaccine delivered via the nasal route.

Bharat Biotech is also working on another intra-nasal vaccine called CoroFlu with virologists from the University of Wisconsin Madison, US, and the vaccine companies FluGen, the company had announced in April.

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