A unique intranasal vaccine for coronavirus, ‘CoroFlu’, is all set to take on the deadly Covid-19.
An international collaboration of virologists at the University of Wisconsin–Madison and the vaccine companies FluGen and Bharat Biotech-has begun the development and testing of the unique vaccine named ‘Coroflu’ against the COVID-19 that has infected over one million people and claimed over 54,000 lives.
Bharat Biotech has till date commercialised 16 vaccines, including a vaccine developed against the H1N1 flu that caused the 2009 pandemic.
Head of Business Development, Hyderabad based Bharat Biotech pharma, Dr Raches Ealla explained that, CoroFlu will be built 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.
“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,” Dr Ella said, sharing further details.
He said, “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.”
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 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,” said Gabriele Neumann, a senior virologist in Kawaoka’s lab and co-founder of FluGen. “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.”
CoroFlu, like M2SR, will be delivered intranasally. This route of administration mimics the natural route of infection by coronavirus and influenza and activates several modes of the immune system.
Intranasal delivery is more effective at inducing multiple types of immune responses than the intramuscular shots that deliver most flu vaccines.
“Ninety percent of our vaccines are sold in lower middle-income countries with affordable pricing being core to our business model. We will fervently work toward the successful development of an efficacious COVID-19 vaccine,” said Dr Ella.