By Mohammed Shafeeq
Hyderabad, Apr 30 (IANS): Bharat Biotech believes that the flu 'backbone' gives an attractive option and provides a regulatory headstart for rapidly developing a safe and effective vaccine for fighting the Covid-19 virus.
Bharat Biotech Chairman and Managing Director, Dr. Krishna Ella told IANS in an interview that their vaccine CoroFlu stands apart from other candidates as it is 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.
CoroFlu, being developed under an international collaboration, is built on the backbone of FluGen's flu vaccine candidate known as M2SR. Based on an invention by the University of Wisconsin-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.
The Hyderabad-based vaccine maker hopes that human clinical trials of the intranasal vaccine CoroFlu could begin towards the end of 2020.
"Right now, our International partners, Kawaoka and Neumann group are assessing CoroFlu's safety and efficacy in animal models at the UW-Madison's Influenza Research Institute. The development of the vaccine and testing in laboratory animal models by Dr. Yoshihiro Kawaoka team at UW-Madison is expected to take approximately four-six months," said Dr Ella.
Dr Kawaoka is the world's leading expert on influenza research.
Toxicology studies on animals are underway and are is likely to take a few more weeks. Once the efficacy and all other protocols are met, Bharat Biotech will begin the next phase of the vaccine development, moving into phase 1 of human clinical trials.
"Once we are confident that the results are robust, we will begin trials on humans. CoroFlu could be in human clinical trials by the fall of 2020," he said.
The technology transfer between FluGen and Bharat is also underway to ensure rapid manufacturing and scale-up.
The animal trials are very critical and post these results, Bharat Biotech will begin production scale-up for safety and efficacy testing in humans.
"Our biggest challenge, or for that matter for a pandemic vaccine company, is to establish the highest standards of efficacy, safety, and stability for a vaccine. So, every stage, every step of trials from animals to human clinical trials are crucial for the eventual outcome of a human ready vaccine. The support from the government is very heartwarming and relaxation of regulations will pave way for accelerating the vaccine development," said Ella.
CoroFlu, like M2SR, will be delivered intranasally. Asked about the reasons for going for an intranasal vaccine, Ella explained that 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."
He claimed that Bharat Biotech applies innovative technologies to deal with healthcare concerns of the developing world, and to provide it with affordable, high-quality vaccines and therapeutics. "We have good expertise in developing vaccines for epidemics/pandemics such as having already/developed a vaccine for the H1N1 epidemic (Swine Flu) and a vaccine for Zika which is currently undergoing clinical trials."
Ella pointed out that 90 percent of Bharat Biotech's vaccines are sold in lower middle-income countries with affordable pricing being central to their business model.
"We continue to zealously work towards the successful development of efficacious pandemic vaccines, vaccines for neglected diseases including a 'Made in India', and a 'Make in India' vaccine to tackle the Covid-19 pandemic," he added.