Introduction

Influenza is a serious public health, economic, and national security threat. Every year, circulating seasonal influenza viruses infect tens of millions of people in the United States, leading to hundreds of thousands of hospitalizations and tens of thousands of deaths (Figure 1).¹ Widespread influenza infection can significantly compromise national security by diminishing the domestic workforce (including military personnel), weakening critical infrastructure, and impeding logistics networks. The September 2019 Council of Economic Advisors (CEA) Report estimates that seasonal influenza costs the United States approximately $361 billion per year.² Moreover, influenza viruses have a potential to cause pandemics due to their high mutation rate and could result in millions of deaths worldwide. The CEA Report also indicates that such events are likely to cost between $413 billion to $3.79 trillion to the United States’ economy, depending on their severity and scope.³

FIGURE 1: ESTIMATED RANGE OF ANNUAL INFLUENZA
BURDEN IN THE UNITED STATES SINCE 2010*

*The top range of these burden estimates are from the 2017-2018 influenza season.
These are preliminary and may change as data are finalized.
Source: Center for Disease Control and Prevention

While currently available influenza vaccines are imperfect, they still represent the most effective strategy to prevent influenza infections, reduce the severity of illness, save lives, and respond to both seasonal influenza epidemics and potential pandemics. Currently, influenza vaccine manufacturers produce seasonal vaccines based on pre-season sales and on the predicted start of influenza seasons. This production and delivery process is not designed for maximum flexibility to respond to a newly emerging seasonal virus that is not matched to the forecasted vaccine composition; this process is neither optimized nor incentivized for the speed and scale expected to be needed during a pandemic. During a pandemic, any delay in detecting a novel strain; sharing of influenza virus samples; or developing, producing, distributing, or administering a vaccine could result in significant additional morbidity and mortality. While substantial progress in influenza preparedness and prevention has been made, significant gaps remain: domestic vaccine production is inefficient and insufficient, vaccine effectiveness is less than optimal, and vaccination rates across the United States are too low.

Coordinated partnerships – involving federal, state, local, tribal, and territorial (SLTT) governments; industry and private partners; non-governmental organizations; academia; professional associations; the World Health Organization and other international stakeholders; and consumers – are critical to address gaps in vaccine effectiveness, coverage, sustainable manufacturing, and diagnostic and treatment capabilities. The Executive Order (EO) 13887 on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health⁴ aims to address these gaps through four policy objectives:

• Reduce the United States’ reliance on egg-based influenza vaccine production;
• Expand domestic capacity of alternative methods that allow for more agile and rapid responses to emerging influenza viruses;
• Advance the development of new, broadly protective vaccine candidates that provide more effective and longer lasting immunity; and
• Support the promotion of increased influenza vaccine immunization across recommended populations

While the EO requires a five-year approach, influenza vaccine development and licensure is a time consuming, complex, and expensive process requiring a combination of public and private involvement. Therefore, the NIVMS provides a 10-year strategic approach to systematically transform the United States’ influenza vaccine enterprise to be more robust, resilient, scalable, and nimble in the face of seasonal influenza epidemics and future influenza pandemics.

¹ Centers for Disease Control and Prevention. “Disease Burden of Influenza.” Retrieved from Disease Burden of Influenza

² Council of Economic Advisers (CEA). (2019). “Mitigating the Impact of Pandemic Influenza through Vaccine Innovation.” Retrieved from Mitigating the Impact of Pandemic Influenza through Vaccine Innovation

³ Ibid

⁴ White House. (2019). The Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health. Retrieved from Executive Order on Modernizing Influenza Vaccines in the United States to Promote National Security and Public Health