Senator Edward J. Markey (D-Mass.) on Thursday introduced the Flu Vaccine Act, legislation to conduct or support comprehensive research for the creation of a universal influenza vaccine that could be administered once or twice and provide a lifetime of protection. The legislation is calling for a total investment of $1 billion – $200,000,000 for each of fiscal years 2019 through 2023 for the National Institutes of Health (NIH).

A person receives the seasonal influenza vaccine (flu shot). Imahe/NIAID
A person receives the seasonal influenza vaccine (flu shot).

The National Institute of Allergy and Infectious Diseases within NIH spent an estimated $64 million for universal flu vaccine research in fiscal year 2017. The United States has already seen 63 pediatric deaths and high levels of illness and hospitalizations related to the flu this season. One-in-10 Americans who died the week ending on January 20th died from the flu or pneumonia. 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. The current flu vaccine is only 60 percent effective at best, with some estimates putting the effectiveness of this year’s vaccine as low as 10 percent.

“America’s scientists and clinicians are gold medalists in health and disease research, and is it is up to the United States to lead the world in the response to the flu,” said Senator Markey. “We must enhance our ability to predict the right strain for the next season, produce a more optimal vaccine, and protect all Americans against all strains of this virus. The Flu Vaccine Act will help provide dedicated, consistent resources so that we can perform the basic science research necessary to improve upon our current vaccine and ultimately develop a universal one.”

Senators co-sponsoring the Flu Vaccine Act are Tammy Baldwin (D-Wis.), Richard Blumenthal (D-Conn.), Angus King (I-Maine.), Amy Klobuchar (D-Minn.), Bill Nelson (D-Fla.), Tina Smith (D-Minn.), and Chris Van Hollen (D-Md.).

At an event Thursday discussing the Flu Vaccine Bill, Dr. Paul Auwaerter, president of the Infectious Diseases Society of America made the following remarks:

“This has been a serious influenza season. We are witnessing more widespread infection and severe illness than in the past decade. The consequences include potentially preventable deaths, hospitalizations, and illness leading to missed work and school. This all clearly speaks to the urgent need for a durable and universal influenza vaccine. The most prevalent influenza strain this year, the H3N2 virus, causes more serious illness, while at the same time the vaccines produced tend to be less effective because our current manufacturing processes may contribute to unintended mutations. Senator Markey’s bill will provide important resources to help overcome this problem.

“As an infectious diseases physician, I have seen some of the devastating results.

“Last week a child was admitted to the hospital who had been diagnosed with influenza the previous week.  The patient is now on life support due to overwhelming viral infection that led to heart failure and renal failure. Two patients in the Intensive Care Unit were critically ill on ventilators because their influenza led to overwhelming, necrotizing bacterial pneumonia.

“Cases like these are happening across the country. Such tragedies underscore the serious need to develop broad, effective protection against influenza regardless of each season’s primary strains. New approaches are needed to develop an effective and more durable universal influenza vaccine. Current vaccines are based on the immune system responding to the influenza hemagglutinin (HA) protein that varies depending on the circulating strains of influenza, often changing rapidly requiring yearly vaccination. It is important that we invest the resources necessary to overcome these scientific hurdles to find new methods, and Sen. Markey’s bill will be extremely helpful.

“A coordinated and comprehensive response for influenza research and development will strengthen our public health infrastructure, and substantially lead to a more ready and healthier workforce.

“In addition to a better vaccine, we need improved influenza diagnostics and antiviral drugs.  We also need to invest in our public health system so that surveillance and tracking can help us understand influenza’s impact and how we can better prevent infection.  This will help inform policies to increase the number of individuals who receive the influenza vaccine—that the CDC recommends for all individuals over 6 months of age.  Dedicated requirements that health care personnel receive flu shots to protect their own health and to prevent spread to the vulnerable patients they serve have been highly effective.

“This influenza season also underscores the importance of a highly skilled workforce of clinicians, researchers and public health experts who can swiftly mobilize to address severe influenza by caring for critically ill patients, conducting research for vaccines and other countermeasures, and implementing public health interventions.  Fewer young physicians are pursuing the infectious diseases specialty, yet there is increasing demand for such expertise. How medical students and young physicians choose careers has been strongly influenced by their financial burdens. Strategies are clearly needed that address the high financial burdens of medical education as well as the compensation in a field where practitioners earn significantly less income that physicians in other specialties that require the same amount of training.

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The severity of this influenza season is also compounded by another public health crisis — antimicrobial resistance.  Many hospitalizations for influenza, including the cases of my two patients in intensive care, and many influenza deaths are attributable to secondary bacterial pneumonia that is increasingly difficult to treat due to antimicrobial resistance. The scarcity of new antibiotics in development mean there will be worse problems with untreatable infections as bacteria continue their relentless development of resistance to these miracle medicines of the 20th century. We need research efforts and incentives to stimulate new miracle drugs for our century.

“This year’s flu season has highlighted many ways we can do better, in protecting individual and public health by developing new tools and ensuring access to the ones we have. Senator Markey’s proposal is a good start at a good time. It will speed the way to a time when the approach of the influenza season doesn’t inspire dread.”

Additionally, Senator Markey and his colleagues sent a letter today to the Secretary of Health and Human Services (HHS) asking for more information on how the department is preparing for and responding to the flu virus. Specifically, the Senators request additional detail on the department’s work to predict more accurately the right viral strain for upcoming flu seasons, produce vaccines more rapidly and effectively, prepare hospitals and providers for the risks of a severe flu season, and protect all Americans against the virus through developing a universal flu vaccine.