Saturday, October 23, 2021

Bharat Biotech’s intranasal vaccine to enter phase I/II trials by month-end


Vaccine producer Bharat Biotech International (BBIL) could begin phase I/II human clinical trials for its single-dose intranasal vaccine candidate for Covid-19 by the end of December or early next month, its chairman, Krishna Ella, said on Tuesday. Ella told a global conclave on coherent dissemination of Covid-19 vaccines and therapeutics that the company does not want to add to the environmental pollution that may be caused by billions of syringes and needles that will be used for Covid-19 vaccines.

In September, the Hyderabad-headquartered vaccine producer had signed a licensing agreement with Washington University School of Medicine for a novel chimp-adenovirus, single-dose intranasal vaccine for Covid-19. “As high as 2.6 billion syringes and needles are required to vaccinate 1.3 billion Indian population with the double-dose Covid-19 vaccine, which will lead to disastrous environmental pollution,” said Ella, adding, “We have partnered with Washington University School of Medicine for a single-dose intranasal vaccine and we are working on it.”

The conclave was organised by the Confederation of Indian Industry in partnership with Consulate General of Belgium.

Ella said the novel chimp-adenovirus, single-dose intranasal vaccine candidate for Covid-19 is now “getting into Phase I/II clinical trials by end of this month or early next month”. While announcing the licensing agreement in September, BBIL had said phase-I trials will take place in Saint Louis University’s Vaccine and Treatment Evaluation Unit and upon obtaining the required regulatory approval, it will pursue further stages of clinical trials in India.

BBIL said it owns the rights to distribute the vaccine in all markets except the US, Japan and Europe and that it will undertake largescale manufacture of the intranasal vaccine, which showed positive results in mice studies at its facility in Hyderabad. At a conference of the Indian School of Business last month, Ella had said that the company expects to get the intranasal Covid-19 vaccine ready by next year, which will address the huge logistical challenges involved in the last-mile delivery and administering of the vaccine.

An intranasal vaccine will not only be simple to administer but also reduce the use of medical consumables such as needles and syringes, thereby significantly impacting the overall cost of a vaccination drive, said Ella. This is the second intranasal vaccine candidate that BBIL is working on. It had signed an agreement in April to work with virologists at the University of University of Wisconsin-Madison and the vaccine company FluGen for a unique intranasal vaccine CoroFlu against Covid-19.

Bharat Biotech has a portfolio of vaccines currently being developed for Covid-19 that are at various stages of clinical development. This portfolio includes Covaxin, which is currently in phase-III human clinical trials in India for which the company had signed a deal in June, collaborating with the Indian Council of Medical Research and National Institute of Virology. On Monday, the company moved the Indian drug regulators seeking emergency use authorisation for Covaxin. In May, Bharat Biotech had signed an exclusive deal with Thomas Jefferson University of Philadelphia to develop a new vaccine candidate for Covid-19 invented at the university. The novel vaccine candidate was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins.





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