By Viva Sarah Press
Renewed urgency for a better flu vaccine has again hit the headlines, as health officials in the United States sum up the outgoing flu season’s death toll and warn of possible future pandemics.
Hoping to keep the next possible influenza epidemic at bay, the National Institutes of Health announced its new Phase 2 clinical trial of investigational universal influenza vaccine — the M-001 vaccine candidate, developed and produced by BiondVax Pharmaceuticals based in Ness Ziona – which it hopes will prove protective against multiple strains of the virus.
“The 2017-2018 influenza season in the United States was among the worst of the last decade and serves as a reminder of the urgent need for a more effective and broadly protective influenza vaccine,” National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony S. Fauci, said in a May 4 statement.
Likewise, the Bill and Melinda Gates Foundation and Lucy and Larry Page recently announced a $12 million investment to push scientists toward finding a game-changing solution to end the threat from both seasonal and pandemic influenza.
“The goal is to encourage bold thinking by the world’s best scientists across disciplines, including those new to the field,” Gates told attendees at New England Journal of Medicine’s annual Shattuck Lecture in Boston recently.
The 2017-2018 flu season in the US posted the highest death count among children in at least five years, health officials said.
Moreover, the Centers for Disease Control and Prevention showed that while flu vaccines usually prevent 40 percent to 60 percent of flu cases, this past year’s vaccines were just 36 percent effective overall.
The new trial — sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) – and being conducted under an FDA Investigational New Drug (IND), marks M-001’s clinical debut in the United States.
“We are pleased to participate in NIAID’s focus on the development of novel flu vaccines to improve protection against current strains and protect against emerging seasonal and pandemic threats,” said Dr. Ron Babecoff, BiondVax’s CEO.
The NIH-sponsored trial is being led by principal investigator Dr. Robert L. Atmar of Baylor College of Medicine in Houston. The study is being conducted at four US sites that are part of the NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs).
“An effective universal influenza vaccine would lessen the public health burden of influenza, alleviate suffering and save lives. There are numerous paths of inquiry that the scientific community is pursuing, with each new study yielding more critical information and bringing us closer to our shared goal,” said Fauci.
Dr. Atmar said in a press release by Baylor that “there is a great need to develop a vaccine that protects against all strains of influenza and doesn’t need to be changed from year to year. We hope that this study is a step in that direction.”
The Gates-Page challenge, Ending the Pandemic Threat: A Grand Challenge for Universal Influenza Vaccine Development, comes during the centenary year of the 1918 Spanish flu pandemic that killed 50 million people around the globe. According to a simulation by the Institute for Disease Modeling, if a comparable contagious airborne pathogen were to occur today, more than 33 million people worldwide would die in six months.
“Bill Gates has been talking about finding a universal flu vaccine for years, that he’s sure there’s going to be another flu pandemic and that we’re not ready for it. Which is likely correct,” says Joshua Phillipson, Business Development and Marketing manager for BiondVax. “The $12 million Grand Challenge to fund research of universal flu vaccines is for early-stage ideas, it is seed money. But it is important because this announcement fuels new interest.”
Initially developed in Professor Ruth Arnon’s lab at the Weizmann Institute of Science in Israel, M-001 is comprised of nine epitopes common to influenza virus strains including both influenza Type A and B. BiondVax has completed six clinical trials in Israel and Europe.
Phillipson says his company’s “universal flu vaccine is the most advanced in terms of clinical trials. No other candidate has completed this many clinical trials.”
The new US study will enroll up to 120 healthy volunteers between the ages of 18 and 49 years. Participants will be assigned randomly to receive either two doses of the experimental vaccine or a placebo. All participants will also receive an approved seasonal influenza vaccine. The scientists will evaluate the participants’ immune responses to both the experimental vaccine and to the seasonal vaccine.
SEE ALSO: Flu Vaccine Co. BiondVax Raises $2.8M
Phillipson says the Israeli company has a pivotal clinical efficacy Phase 3 trial on the horizon as well. Co-funded by the European Union’s European Investment Bank (EIB), the trial will enroll 9,630 participants aged 50 years and older across four to six countries over a period of two flu seasons.
“Given the continual emergence of new pathogens, the increasing risk of a bioterror attack, and how connected our world is through air travel, there is a significant probability of a large and lethal modern-day pandemic occurring in our lifetimes,” Gates said.
Unless a universal flu vaccine can stop it, of course.