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Friday, November 1, 2019

Quest for Universal Flu Vaccine Boosted by $200M NIH Grant to University of Maryland

Quest for Universal Flu Vaccine Boosted by $200M NIH Grant to University of Maryland


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Story Highlights
  • National Institutes of Health (NIH) has awarded the University of Maryland a contract for more than $200 million to develop a universal influenza vaccine.
  • Currently, the influenza vaccine used around the world is developed every year by drug companies based on the “best guesses” made by public health officials at the World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC), who predict which type A and B influenza strains will be prevalent in the upcoming flu season and should be included in flu vaccines.
  • Grant money awarded by the National Institute of Allergy and Infectious (NIAID), as well as grant money from The Bill and Melinda Gates Foundation in collaboration with Flu Lab and others, will be used to develop a “universal” flu vaccine that will cover a broad range of influenza strains and can be given at any time during the year.
The annual influenza vaccine that includes certain type A and B influenza strains is a constantly moving target, with public health officials at the World Health Organization (WHO) and U.S. Centers for Disease Control and Prevention (CDC) relying on educated guessing to predict which influenza strains will prevail globally in any given year so drug companies manufacturing flu vaccines can include the selected influenza vaccines in seasonal flu shots. The problem for vaccine manufacturers is that the predictions by public health officials too often prove to be wrong and these miscalculations have consistently resulted in influenza vaccines with rates of effectiveness less than 50 percent and sometimes as low as 10 percent.1 2
The influenza vaccine has seldom lived up to expectations and public confidence in the vaccine has not been particularly high. It is within this environment that the quest for a more effective “universal” influenza vaccine has become a major priority of public health officials and the vaccine industry.
The quest for a universal influenza vaccine recently received a big boost with a federal government grant of more than $200 million awarded to the University of Maryland School of Medicine (UMSOM) by the National Institute of Allergy and Infectious (NIAID). The vaccine development research contract, which is being given for the express purpose of developing a universal flu vaccine, will be distributed annually over the next seven years under the direction of Kathleen Neuzil, MD, MPH, who is professor of Medicine and Pediatrics and director of the Center of Vaccine Development and Global Health (CVD) at the University of Maryland.3
Beginning with an initial payment of $2.5 million to evaluate seasonal vaccines currently in development, the CVD’s Collaborative Influenza Vaccine Innovation Center (CIVIC) program also expects to conduct clinical and challenge studies in adults and specific groups including children, pregnant women and the elderly.
Dr. Neuzil said, “There are already vaccines in the pipeline that have been developed and are ready for human testing… If we had to start from scratch in developing vaccines, it would take much longer.” She said that her research group will look at vaccine candidates with novel approaches to preventing all influenza infections, rather than the current strategy of targeting different strains of the influenza virus each year. One new tactic is to change the source of the pathogen used in the vaccine, away from the current practice of using surface proteins of the constantly mutating influenza virus, to just targeting the part of the protein that stays the same.4
Dr. Neuzil is a widely recognized researcher and advocate for the vaccine industry, holding prominent roles in helping to determine public vaccine policies, both domestically and internationally. She is a member of the CDC Advisory Committee on Immunization Practices (ACIP) and the only U.S. member of the World Health Organization’s (WHO) Strategic Advisory Group of Experts on Immunization (SAGE). Under her leadership, the CVD is also active in research into finding vaccines malaria, anthrax, Dengue, Ebola virus, meningitis, and Hantaan virus.5

NIAID is Not the Only Influenza Vaccine Benefactor

Other influential groups are also pushing for greater funding for research into developing a universal influenza vaccine. The Bill and Melinda Gates Foundation, together with the philanthropy group Flu Lab, initially proposed a series of grants that were to be rolled out in August of 2018 and were expected to produce a universal flu vaccine ready for testing in humans by 2021.6
The Gates Foundation submitted proposals, which led them to realize that the “field of influenza vaccinology simply isn’t that close to being able to design a flu vaccine that would protect broadly against the strains of flu that infect people every winter and those in nature that could emerge to trigger a disruptive and deadly pandemic.” The grants were changed to focus on more basic research needed to create a knowledge base that would make the development of a universal flu vaccine more feasible.6

Two “Camps” in Universal Influenza Vaccine Research

There are two very different vaccine development approaches grouped under the universal flu vaccine umbrella. The first is focused on broadening the coverage of the annual influenza vaccine, but does not seek to provide coverage against all influenza  strains. The second type of research seeks to develop a vaccine to cover the “multitude of strains that exist in nature, one which would not need to be frequently updated as the flu viruses mutated.”7
Similar to the plans of Dr. Neuzil’s group at the University of Maryland, one of the grantees supported by the Gates initiative will focus on a different target on the influenza virus. Calling their project “MONSTIR” (MOsaic Natural Selective Targeting of Immune Responses), researcher Patrick Wilson, PhD, professor of medicine and rheumatology at the University of Chicago, aims to create a universal flu vaccine from “a combination, or mosaic, of proteins from different segments of multiple virus strains.” Dr. Wilson likens their approach to “building a Frankenstein’s monster of flu proteins, and thus the MONSTIR acronym.”8
Recognizing that influenza viruses mutate constantly, Wilson’s group intends to start with influenza strains that bind antibodies at sites on the virus that are less likely to mutate.

Why is a Universal Flu Vaccine So Elusive?

Part of the reason the quest for a universal influenza vaccine has been slow, particularly compared to the development of other vaccines like those for the Zika and Ebola viruses, may have to do with economics, as suggested by reporter Maryn McKenna.
McKenna noted in 2017 that, “The current, imperfect flu vaccine brings in more than $3 billion per year worldwide.”9 Quoting Michael Osterholm, founder of the Center for Infectious Disease Research and Policy at the University of Minnesota, she added:
The real challenge is that there is already an established, and very mature, private-sector enterprise producing flu vaccine that has in place a system of annual delivery that guarantees a certain amount of money… How are you going to change that? Who is going to pay for that, given that the cost of research and development may mean the vaccine will be substantially more expensive than what we already have? What company will embrace that?9
One answer to that question may lie in a statement made by U.S. Senator Christopher Van Hollen (D-Maryland), who introduced a bill in February 2019 to dedicate $1 billion over five years to influenza vaccine research. Quoting CDC generated data that estimates annual costs of influenza in the U.S. at $10.4 billion in direct medical expenses and $87 billion in economic losses, Sen. Van Hollen pointed out that a universal flu vaccine that might need to be repeated only once every five or 10 years and covers many varieties of influenza would mean that, “Every healthcare encounter would be an opportunity to provide that vaccine, not just every fall.”10

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