Hyderabad: Bharat Biotech developing vaccine

Hyderabad: At a time when the world is battling coronavirus pandemic, city-based Bharat Biotech, a renowned vaccine maker, has on Friday announced that it is developing a vaccine against COVID-19 called CoroFlu as part of an international collaboration of virologists and vaccine makers. CoroFlu, an one drop COVID-19 nasal vaccine, will be built on a flu vaccine 'backbone' that has already been shown to be safe and well-tolerated in humans in Phase I and Phase II clinical trials.

Once developed, the vaccine will also be delivered intranasally. Announcing that the vaccine is under development and testing, the company said the project is an international collaboration of virologists at the University of Wisconsin–Madison, US and the vaccine company FluGen along with 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," Dr Raches Ella, Head of Business Development, Bharat Biotech, said in a statement.

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

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. 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 coronavirus.

"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. The vaccine could be in human clinical trials by the fall of 2020 (towards end of September this year)," the company said.

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, it added.

"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.

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, she added.

The new vaccine 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 per cent 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 Raches Ella.