Hyderabad (Telangana) [India], Apr 4 : Bharat biotech is developing a one drop COVID-19 intranasal vaccine 'CoroFlu' using a proven safety platform.
The vaccine, 'CoroFLu' is built on a flu vaccine "backbone", which has already proved to be safe and well tolerant when given to humans, in Phase I and II of the clinical trials.
The medicine is being developed by Bharat Biotech is an international collaboration with virologists at the University of Wisconsin-Madison and the vaccine compes FluGen
CoroFlu will build on the backbone of FluGen's flu vaccine candidate known as M2SR. It is 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.Raches Ella, Head of Business Development, Bharat Biotech 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,"
Raches added, "Bharat Biotech has commercialized 16 vaccines, including a vaccine developed against the H1N1 flu that caused the 2009 pandemic."
Refinement of the CoroFlu vaccine concept and testing in laboratory mal 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.
( With inputs from ANI )