Hyderabad: Hyderabad-based vaccine maker Bharat biotech is developing a unique intranasal vaccine for Coronavirus. The vaccine, likely to be named CoroFlu, will be built on a flu vaccine backbone named M2SR, which has already proved to be safe and well tolerant when given to humans, in Phase I and II of the clinical trials.
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.
An international collaboration with virologists at the University of Wisconsin-Madison and the vaccine companies FluGenCoroFlu along with Bharat Biotech has begun the development and testing of a unique vaccine against Coronavirus, a release from Bharat Biotech said.
Dr. Raches Ella, Head of Business Development, Bharat Biotech told ANI, "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," Raches added.
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.
The 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 coronavirus vaccine.