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Intranasal vaccine for Covid-19 under development: Bharat Biotech

An intranasal vaccine for Coronavirus, 'CoroFlu' is under development, vaccine-maker Bharat Biotech said on Friday.

An international collaboration of virologists at the University of Wisconsin-Madison and the vaccine companies FluGen along with Bharat Biotech has begun the development and testing of CoroFlu.

CoroFlu will build on the backbone of FluGen's flu vaccine candidate known as M2SR.

Based on an invention by UW-Madison virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu.

SARS-CoV-2
Kawaoka's lab will insert gene sequences from SARS-CoV-2, the novel coronavirus that causes the disease COVID-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus.

According to Raches Ella, Head of Business Development, Bharat Biotech, Bharat Biotech will manufacture the vaccine, conduct clinical trials, and prepare to produce almost 300 million doses of vaccine for global distribution.

Under the collaboration agreement, FluGen will transfer its existing manufacturing processes to Bharat Biotech to enable the company to scale up production and produce the vaccine for clinical trials.

Bharat Biotech has commercialized 16 vaccines, including a vaccine developed against the H1N1 flu that caused the 2009 pandemic.

How it is likely to pan out
Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at UW-Madison is expected to take three to six months. Bharat Biotech in Hyderabad, India will then begin production scale-up for safety and efficacy testing in humans. CoroFlu could be in human clinical trials by the fall of 2020.

Four Phase I and Phase II clinical trials involving hundreds of subjects have shown the M2SR flu vaccine to be safe and well tolerated. This safety profile, M2SR's ability to induce a strong immune response, and the ability of influenza viruses to carry sequences of other viruses make M2SR an attractive option for rapidly developing CoroFlu as a safe and effective SARS-CoV-2 vaccine.

"We are going to modify M2SR by adding part of the coding region for the coronavirus spike protein that the virus uses to latch onto cells and begin infection," Gabriele Neumann, a senior virologist in Kawaoka's lab and co-founder of FluGen, said.

"CoroFlu will also express the influenza virus hemagglutinin protein, which is the major influenza virus antigen, so we should get immune responses to both coronavirus and influenza."

M2SR is a unique form of the flu virus. It lacks a gene called M2, which restricts the virus to undergoing only a single round of replication in cells.

CoroFlu, like M2SR, will be delivered intranasally.

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