The University of Minnesota's Center for Infectious Disease Research and Policy has issued a report claiming that current flu vaccines offer less protection against seasonal flus than previously thought, and better ones are needed.
According to the report, there's a misconception that the flu vaccines currently available are highly effective -- and that's getting in the way of creating more effective vaccines.
The 160-page report, titled "The Compelling Need for Game-Changing Influenza Vaccines," explains that the current US-licensed trivalent inactivated influence vaccine (TIV) is not much different from the one first developed in 1968, and the live-attenuated influenza vaccine that was licensed in 2003 is made using techniques from the 1930s.
The report authors also state that unlike the options currently available, there are innovative vaccines currently in the investigational research stage could offer lasting, broad and potent protection against both seasonal and pandemic influenza; however, "substantive research and policy support is needed."
"Achieving these goals and bringing novel influenza vaccines to the global market will require a highly-coordinated leadership effort, similar to the mission-critical prioritization and project management approach of the Manhattan Project," the authors wrote.
Influenza vaccine production is a risky business financially, and the report says there are inadequate incentives to bring a "game-changing" vaccine to the market because it can take up to 15 years and more than $1 billion to complete the vaccine creation and licensing process. Innovative vaccines would likely also face the same hurdles as traditional vaccines but would also face an additional challenge of a longer version of the already-daunting approval process, thus upping the financial risks.
Since the influenza vaccine market is a relatively stable one for manufacturers, the report authors argue those businesses have less of an incentive to support an innovative vaccine, which could potentially change the industry. Start-up companies, meanwhile, often do not have the financial backing to survive clinical trials, described in the report as the "valley of death" for new approaches.
To overcome this challenge, the report advocates for coordinated partnerships between the federal government, the pharmaceutical industry, investors and academia to facilitate development.
While describing current flu vaccine policy goals as laudable, the report insists that policymakers must start recognizing the "critical limitations" of current vaccines and the limited impact recent strategies have accomplished. Given the perception that current vaccines are effective, the report authors argue that has precipitated a lack of political will to make a novel vaccine into a national health priority.
If that were to change, the policies regarding investments, organization and leadership that create barriers in new vaccine research would also need to change, the report says. The authors advocate for a new paradigm that includes financial incentives -- both federal and private -- and focuses on resource efficiency and scientific analyses.
The authors urge the U.S. government to spearhead the charge, and recommends international agencies and governments -- including the World Health Organization -- support them in the effort while establishing an internationally-accepted standard for evaluating vaccines.
Each year, between 3,000 and 49,000 Americans die from seasonal influenza each year. Worldwide, the WHO estimates influenza is responsible for 250,000-500,000 deaths annually.