Hyderabad, Apr 04, 2020: Vaccine manufacturer Bharat Biotech is working on an intra-nasal vaccine against Covid-19, called CoroFlu, in collaboration with US-based vaccine company FluGen and virologists at the University of Wisconsin (UW)–Madison. The company will manufacture the vaccine, conduct clinical trials and produce about 300 million doses for global distribution.
Under the agreement, FluGen will transfer its existing manufacturing processes to Bharat Biotech to help the company produce the vaccine for clinical trials and, subsequently, to scale up production, Dr Raches Ella, head of business development, Bharat Biotech, said Yahoo.
"Bharat Biotech has commercialised 16 vaccines, including the one developed against the H1N1 flu that triggered the 2009 pandemic," Ella added. CoroFlu will be built on the backbone of FluGen’s flu vaccine candidate called 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 Covid-19, into M2SR so that the new vaccine will also induce immunity against the virus.
Refinement of the CoroFlu vaccine concept and its testing on animals in the UW–Madison laboratory is expected to take three to six months. Bharat Biotech will then scale-up production for safety and efficacy-testing in humans. CoroFlu could be ready for clinical trials on humans by the fall of 2020. Mucosal immunity, derived in the lining of the nose and respiratory tract, is very critical for respiratory illness. CoroFlu is based on the influenza vaccine and will provide immunity to H2N2 strain of seasonal influenza.
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."
M2SR is a unique form of the flu virus. It lacks a gene called M2, which restricts the virus from undergoing only a single round of replication in cells. "The single replication means the virus can enter the cell, but it can’t leave," said FluGen co-founder, president and CEO Paul Radspinner. "So, in essence it tricks the body into thinking it’s infected with flu, which triggers a full immune response. But since it can’t replicate further, you don’t get sick."
CoroFlu, like M2SR, will be delivered intra-nasal. This route of administration mimics the natural route of infection by coronavirus and influenza and activates several modes of the immune system. Intra-nasal delivery is more effective at inducing multiple types of immune responses than the intramuscular shots that deliver most flu vaccines. The Kawaoka group will insert genetic sequences from SARS-CoV-2 into M2SR and then assess CoroFlu’s safety and efficacy in animals at UW–Madison’s Influenza Research Institute.
The institute has a high-level bio-safety facility designated Biosafety Level 3 Agriculture with the ability to safely handle and study pathogens like highly pathogenic influenza viruses and the novel coronavirus. M2SR was developed by FluGen and includes technology exclusively licensed through the Wisconsin Alumni Research Foundation (WARF), which manages patents for UW–Madison.