While developing a universal influenza vaccine has been a high priority for a number of years for the U.S. government's top infectious disease expert, he said the time is ripe now for a "full-court press" in investment and resources from all stakeholders to make that product a reality.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, or NIAID, said the best way to achieve a universal flu vaccine is by building a consortium of multidisciplinary scientists from government, academia and industry focused on accelerating the process.
The reason that approach has not been taken sooner was because of the gaps in the scientific information about the flu, Fauci told S&P Global Market Intelligence.
But advances in influenza virology, immunology and vaccinology have made the development of a universal flu shot now more feasible, he said.
The effectiveness of seasonal influenza vaccines have ranged from 10% to about 60%. Interim data released earlier in February revealed the vaccines being used in the U.S. for the 2017-2018 season are only about 36% effective overall, though health officials cautioned that rate could change based on later information. The current season has seen record-breaking hospitalizations, surpassing the 2014-2015 season when the H3N2 virus — a particularly nasty strain — also dominated.
Low efficacy rates generally are due to a poor match between the strains used to make the vaccines and those that are circulating during the flu season. The virus also may mutate between the time the flu strains are selected and the vaccines are manufactured.
Only recently have researchers been able to gain a clearer understanding about the potential ability to induce a response against the part of the flu virus that does not change from year to year, Fauci said.
"And only recently in the last couple of years has there been enough scientific light at the end of the tunnel to tell us that this is something that there is a pathway to getting to," he said.
Fauci led a meeting in June 2017 that brought together experts from around the world to talk about the important gaps in influenza knowledge and how best to fill those voids.
The scientists determined that a universal flu vaccine should be at least 75% effective against symptomatic influenza; protect against influenza A viruses, with the less prevalent B strains a secondary target; and have durable protection that lasts at least one year and preferably through multiple seasons.
Based on the meeting deliberations, Fauci and his colleagues at the NIAID, which is part of the National Institutes of Health, drew up a strategic plan which they published in the Feb. 28 issue of The Journal of Infectious Diseases.
The plan calls for improving the understanding of the transmission, natural history and pathogenesis of influenza infection; precisely characterizing how protective immunity occurs and how to tailor vaccination responses to achieve it; and supporting the rational design of universal flu vaccines, including designing new immunogens and adjuvants to boost immunity and extend the duration of protection.
In establishing a consortium of scientists for a universal flu vaccine, Fauci pointed to the NIAID's response to the HIV/AIDS crisis as a model, where the agency brought together groups of people with different talents — immunologists, virologists, vaccinologists and biologists — to work as a team.
He said the NIAID would issue an announcement in the near future "to bring together teams of individuals with different areas of expertise to synergize and work together toward developing a vaccine."
The NIAID chief said he anticipated the consortium to consist of groups from around the world, noting NIAID has always made global health "an important component of what we do."
A handful of drugmakers are in the early stages of developing a universal flu vaccine, like GlaxoSmithKline PLC, Johnson & Johnson and Sanofi.
Fauci said he did not see a need to develop a specific division or organizational section within the NIH devoted to developing a universal flu vaccine, like the "center of excellence" model the Food and Drug Administration has established for oncology.
"We have people working on a universal flu vaccine in our intramural program. We have people with significant subject matter expertise in our extramural program. And we have grantees who are very interested right now," Fauci said. "I think this will happen without created a new organizational structure" within NIAID, he added.
Securing the funds
Fauci said the NIAID aims to expand the agency's research resources by establishing long-term human cohorts, supporting improved animal models of influenza and broadening capacity for conducting human challenge studies.
But he acknowledged the agency currently lacks the funding to accomplish those goals and has not yet sought a specific big-money initiative-type of allocation from Congress dedicated to pursuing a universal flu vaccine, like the NIH has done for its research devoted to precision medicine, cancer, the brain and Alzheimer's disease.
"I do hope that we get some money for it, but if we don't, we're still going to make it a high priority," Fauci said.
In publicly making his desire for a universal flu vaccine a priority and talking about it "even more intensively" since the June 2017 meeting, Fauci said he hopes that Congress gets the message.
"There's no secret in anybody's mind right now that I'm making universal flu vaccine a top priority for my institute," Fauci said.
But he admitted "you don't demand to get money. You put in what your priorities are and if you get the money you get it."
If necessary, Fauci said he would "reorder some priorities so that any money that turns over from projects that terminate, I would selectively favor giving it to the work on the universal flu vaccine."
Sen. Ed Markey, D-Mass., who praised the NIAID plan, introduced a bill earlier in February that calls for $1 billion — $200 million each year over five years — to be invested in a universal flu vaccine.
"The flu costs the nation $10.4 billion in direct medical costs annually and $87 billion in total economic burden, yet our current investment is significantly lacking," Markey said.