The overarching vision of the NIVMS is supported by three strategic objectives that align with the four policy objectives from the EO (see Annex A: NIVMS Strategic Objectives Crosswalk to EO 13887 for additional information). The associated objectives for each strategic objective will require dedicated and focused attention over the next ten years.
Strategic Objective 1: Strengthen and Diversify Influenza Vaccine Development, Manufacturing, and Supply Chain
Today, the majority of influenza vaccines are produced in chicken eggs — a process that takes up to nine months to develop and manufacture a vaccine — thus limiting the vaccine’s utility for early pandemic control. Moreover, growing the virus in eggs can inadvertently introduce mutations that may potentially render the final vaccine less effective. Nearly 50 percent of egg-based influenza vaccines are manufactured overseas; insufficient domestic production capacities introduces risks that could hamper our ability to address both seasonal and pandemic influenza.
Alternative manufacturing techniques, including those derived from cell-based, recombinant and other synthetic technologies, have a relatively shorter manufacturing time and do not rely on a supply chain of eggs. Therefore, they have the potential to accelerate the availability of both seasonal and pandemic influenza vaccines, and could also allow for vaccines that more closely match circulating influenza strains. However, currently these new technologies are significantly more costly than production in eggs,5 and the current domestic enterprise for manufacturing these types of vaccines is not sufficient for continuous, large-scale manufacturing.
It is a priority for the USG to reduce the time between declaration of an influenza pandemic and widespread distribution of vaccine sufficient to cover the United States’ population. To this end, the USG is committed to delivering first doses of a finished vaccine within 12 weeks.6 Therefore, it is imperative for the USG to build and maintain national sources of raw materials to ensure a resilient supply chain. Fundamental to influenza preparedness is continuous surveillance and virus characterization to inform vaccine composition and development. For this reason, it is critical to expand global influenza surveillance capacity. Finally, investments in innovative antigen and adjuvant selection strategies could improve the effectiveness of both egg-based and novel vaccine technologies, ultimately enhancing the scale, quality, and efficiency of manufacturing processes.
Objectives
- Objective 1.1: Partner with manufacturers and other private sector stakeholders to promote the development and production of non-egg based influenza vaccines that are safe and effective in all populations.
- Objective 1.2: Develop and implement a sustainable investment strategy with the private sector that allows flexibility in financing for advanced development, licensure, and manufacturing of current and promising new vaccine candidates and vaccine production platforms.
- Objective 1.3: Sustain, leverage, and expand current domestic manufacturing capacities to transition to faster and more scalable vaccine production platforms.
- Objective 1.4: Increase and sustain domestic seasonal influenza vaccine production capacity using alternative technologies that can be leveraged for pandemic response to deliver first doses of a finished vaccine within 12 weeks of an influenza pandemic declaration.
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Strategic Objective 2: Promote Innovative Approaches and Use of New Technologies to Detect, Prevent, and Respond to Influenza
Current influenza vaccines are designed to protect against the three to four influenza virus strains most likely to spread and cause illness during a given influenza season. Since influenza viruses are constantly evolving, current influenza vaccine composition must be reviewed and updated each year. It is also critically important to identify and assess the pre-pandemic potential of viruses.
A “universal” influenza vaccine, one that provides robust, long lasting protection against multiple subtypes of influenza, would be the most effective MCM to reduce morbidity and mortality from seasonal and pandemic influenza infections. Currently, there is a promising pipeline of cross-protective vaccine candidates entering into clinical trials, underpinned by research that builds on our understanding of immune protection against influenza viruses. Since a universal vaccine is likely years away, it is critical that the USG continues to support improvements to vaccines using existing technologies and support complementary MCMs such as antiviral drugs, other therapeutics, and diagnostic tests.
Targeted USG investments and incentives are needed to stimulate advances in science and discovery and to translate these advances into innovations. Therefore, the USG should support traditional and non-traditional partnerships to accelerate the development, licensure and domestic manufacturing capacity of transformative vaccine platforms; antigens, adjuvants, and other vaccine components; therapeutics; devices (e.g., respirators, ventilators); diagnostics; and other MCMs. As influenza MCMs are being developed, it is important to ensure coverage of children, older adults, and other at-risk individuals. Moreover, it is critical to enhance federal and state capabilities to collect, analyze, and share real-time data on pandemic and seasonal influenza threats. These data are critical for coordinated public health response, vaccine development, and effective use of all MCMs.
Objectives
- Objective 2.1: Promote innovative approaches to enhance domestic and global surveillance, characterize seasonal and pandemic influenza viruses, and monitor vaccine effectiveness and safety.
- Objective 2.2: Improve influenza vaccines, diagnostics, and therapeutics using an aligned and integrated research agenda across government agencies, the private sector, and academic institutions to facilitate the transition to alternative technologies.
- Objective 2.3: Apply the full range of regulatory authorities and expedited programs to promote the licensure of new influenza vaccine candidates and the approval of other relevant MCMs.
- Objective 2.4: Advance the development of a universal influenza vaccine that provides robust, long-lasting protection against multiple subtypes of influenza and is suitable for all populations.
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Strategic Objective 3: Increase Influenza Vaccine Access and Coverage Across All Populations
The Centers for Disease Control and Prevention recommends annual influenza vaccination for everyone six months of age and older (with rare exception). Despite these recommendations, seasonal influenza vaccination rates in the United States are far from ideal – about 45 percent of adults and about 62 percent of children were vaccinated during the 2018-19 influenza season.7 There are a number of factors contributing to these low vaccination rates, including lack of public trust, vaccine misconceptions, and lack of access to vaccines. To address these contributing factors, it is imperative that the USG and its partners provide consistent and harmonized communications about the benefits of influenza immunization across all populations and promote increased access to influenza vaccination to improve immunization coverage.
Objectives
- Objective 3.1: Increase and expedite access to influenza vaccines across all recommended populations.
- Objective 3.2: Improve the public’s understanding of influenza risk, as well as confidence in vaccine safety and effectiveness, through evidence-based messaging.
- Objective 3.3: Promote influenza immunization across recommended populations.
- Objective 3.4: Improve existing methods and develop alternative methods for influenza vaccine administration.
- Objective 3.5: Improve capabilities and capacity for management and tracking of influenza vaccination.
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5 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
6 U.S. Department of Health and Human Services. (2017). “Pandemic Influenza Plan: 2017 Update.” Retrieved from Pandemic Influenza Plan: 2017 Update
7 Centers for Disease Control and Prevention. (2019). "Flu Vaccination Coverage, United States, 2018–19 Influenza Season." Retrieved from Flu Vaccination Coverage, United States, 2018-19 Influenza Season
