The outbreak of the novel coronavirus has triggered a paradigm shift in assumptions regarding vaccine development.
The pandemic has made it clear, to governments and big pharma alike, that dedicating significant resources to proactive vaccination strategies are key to save lives. Healthcare systems buckling under the strain of the coronavirus would simply collapse under the additional burden of a severe influenza outbreak.
“Insufficient resources have been implemented and directed toward the important area of vaccination to date,” Dr. Ron Babecoff, the founder and chief executive of Jerusalem-based BiondVax Pharmaceuticals, told The Jerusalem Post.
“It was more sexy to go into rare diseases or even cancers, but we suddenly have an alarm call from nature, telling us that pandemics will occur and they have always occurred. This is a major threat that we are not prepared for. We are always in a status of being reactive, rather than proactive.”
Based on technology pioneered by Prof. Ruth Arnon of the Weizmann Institute of Science, BiondVax is currently in pivotal, clinical efficacy Phase 3 trial for its unprecedented development of a universal flu vaccine (M-001), offering multi-season and multi-strain protection against all seasonal and pandemic human influenza virus strains.
Some 15 years after commencing operations, highly anticipated results of the final clinical trial are expected by the end of the year.
The Nasdaq-listed company’s experience demonstrates the length of time often needed to bring vaccines to market, in contrast to significantly shorter time horizons in other recently-developing fields including immuno-oncology.
“Major innovations like immuno-oncology were brought to market as quickly as five years, rather than 10 to 12 years,” said Samuel Moed, Senior Vice President, Corporate Strategy at global biopharma company Bristol Myers Squibb, who joined BiondVax’s board of directors in March.
“I see encouraging signals that aggressive posturing - like we have in cancer - is happening here very quickly, both in terms of the degree of technology innovation needed in vaccines, and the need for regulators and governments to prioritize and accelerate it.”
The ability to stockpile multi-season and multi-strain influenza vaccines for a number of years, Moed said, “will make our entire system more resilient in light of these periodic pandemics that arise."
Despite the global race for a vaccine against the novel coronavirus, both Babecoff and Moed emphasized that no corners will be cut by medicinal regulators, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). There will be no relaxation of safety standards required for the vaccines, which are given to millions of healthy people.
“If we have good vaccines, then health authorities around the world can be proactive and can prepare the population ahead of time, instead of responding to and managing situations,” said Babecoff. “We are fortunate that the coronavirus is not as deadly as Ebola or Avian Flu. I don't know how long we can count on this luck that we have today.”
Should BiondVax's M-001 vaccine prove successful, matching Babecoff's cautious optimism, then countries will be able to stockpile the vaccine on a large scale and always be ready to vaccinate their population should there be an outbreak elsewhere in the world.
The company's clinical trial timeline and publication of results are unlikely to be affected by the coronavirus pandemic, Babecoff says, as they managed to collect the vast majority of swab samples from participants prior to the outbreak. The study represents the largest ever carried out by an Israeli company.
“In parallel, we are upscaling the manufacturing process at the new site that we built here in Jerusalem. We are in the category of essential industries, so we can work almost as normal despite the Ministry of Health restrictions,” Babecoff said.
“According to our plans, we will finish scale-up by the end of the year, in parallel with the study. We expect to be ready for GMP manufacturing and the regulatory phase starting in the first quarter of 2021.”