2020 National Vaccine Plan Development: Recommendations From the National Vaccine Advisory Committee

Executive Summary

The National Vaccine Plan (NVP)¹ serves as a roadmap for the 21st-century vaccines and immunization enterprise. Mandated by Congress in 1987, the NVP has provided the nation with a comprehensive strategy for enhancing all aspects of vaccination for more than 30 years. The most recent version of the plan was released in 2010. As the immunization landscape and vaccination system continue to evolve, the US Department of Health and Human Services (HHS) intends to release an updated NVP in 2020. The plan will encompass a lifespan approach, covering vaccination from before birth into old age, to immunization policy and practice for the next 5 years.

To support this effort, the Assistant Secretary for Health (ASH) charged the National Vaccine Advisory Committee (NVAC) on March 25, 2019, with developing a report and recommendations to guide the development of the updated NVP. The charge called on NVAC to assess the relevance of existing plan goals, integrate adult immunization goals, prioritize the top objectives within each goal, and identify stakeholders for engagement in the plan’s development.

In response to this charge, NVAC established the NVP Development Subcommittee, which comprised NVAC members, several persons from the private sector with relevant expertise, and HHS staff members. The recommendations in this report will be part of a rigorous process used to inform the final plan, which the HHS Office of Infectious Disease and HIV/AIDS Policy (OIDP) will release in 2020.

After careful assessment of the current NVP, the National Adult Immunization Plan (NAIP),² and midcourse reviews conducted by HHS³ and NVAC⁴ of the NVP, the subcommittee developed recommendations in support of a 5-year plan that reflects immunization priorities across the lifespan (Table 1). These recommendations include changes to each goal, as well as identifying the top 3 priorities poised to make the greatest impact within each goal. To complete the charge from the ASH, NVAC also recommended stakeholders to engage during development of the NVP (Recommendations 2-5). The NVAC recommendations in this report will provide a strong foundation for the development of the 2020 NVP.

Table 1.

Comparison between the 2020 National Vaccine Plan goals recommended by the National Vaccine Advisory Committee and goals of the 2010 National Vaccine Plan^a and the 2016 National Adult Immunization Plan^b

Goals	Recommended 2020 National Vaccine Plan Goals	2010 National Vaccine Plan Goals	2016 National Adult Immunization Plan Goals
Innovation-related goals	Goal 1: Foster innovation in vaccine development and related technologies.	Goal 1: Develop new and improved vaccines.	Goal 4: Foster innovation in adult vaccine development and vaccination-related technologies.
Safety-related goals	Goal 2: Continue to leverage the vaccine safety system.	Goal 2: Enhance the vaccine safety system.	Not applicable
Communication-related goals	Goal 3: Enhance knowledge of and confidence in routine vaccines and the immunization system.	Goal 3: Support communications to enhance informed vaccine decision-making.	Goal 3: Increase community demand for adult immunizations.
Access-related goals	Goal 4: Optimize access to and utilization of all routinely recommended vaccines across the lifespan.	Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the United States.	Goal 2: Improve access to adult vaccines.
Global health-related goals	Goal 5: Promote global immunization.	Goal 5: Increase global prevention of death and disease through safe and effective vaccination.	Not applicable
Infrastructure-related goals	Not applicable	Not applicable	Goal 1: Strengthen the adult immunization infrastructure.

^a Data source: US Department of Health and Human Services.¹

^b Data source: US Department of Health and Human Services.²

Introduction

In 2019, widespread outbreaks of several infectious diseases signaled a changing immunization landscape in the United States and around the world. Global measles cases increased dramatically.⁵ In the United States, the number of measles cases surpassed a 25-year high, with 1241 confirmed cases in 31 states as of September 12, 2019.⁶ In addition, hepatitis A outbreaks affected 30 states, for an estimated total of 25 783 cases, 15 517 hospitalizations, and 259 deaths since 2016.⁷ These outbreaks of vaccine-preventable diseases underscore the threat of infectious disease and the important role a strong immunization system plays in preventing disease and promoting health.

The proliferation of online misinformation about vaccines is an example of how the immunization landscape has transformed since the release of the last NVP in 2010.⁸ The World Health Organization (WHO) recognized vaccine hesitancy as one of the top 10 global health threats in 2019, stating that these threats have the potential to reverse progress made against vaccine-preventable diseases.⁹ At the June 2019 NVAC meeting, HHS Secretary Alex M. Azar II made vaccine confidence an HHS priority, remarking that “one of the most pressing public health challenges our country faces is vaccine hesitancy, driven in part by misinformation.”¹⁰ Vaccination saves lives, but only if people trust that they are safe and effective, and agree to receive the vaccine. Vaccine hesitancy has left many communities undervaccinated, leaving them vulnerable to dangerous infectious diseases,⁸ such as measles.⁹

National Vaccine Advisory Committee

Chair

• Robert H. Hopkins Jr, MD, MACP, University of Arkansas for Medical Sciences, Little Rock, AR

Acting Designated Federal Official

• Ann Aikin, MA, Office of Infectious Disease and HIV/AIDS Policy, US Department of Health and Human Services, Washington, DC

Public Members

• Melody Anne Butler, RN, BSN, Good Samaritan Hospital Medical Center, Lindenhurst, NY

• John Dunn, MD, MPH, Kaiser Permanente Washington, University of Washington School of Medicine, Seattle, WA

• David Fleming, MD, MPH, PATH, Seattle, WA

• Ann M. Ginsberg, MD, PhD, International AIDS Vaccine Initiative, Rockville, MD

• Mary Anne Jackson, MD, Children’s Mercy, Kansas City, MO; University of Missouri–Kansas City, Kansas City, MO

• Melissa Martinez, MD, University of New Mexico, Albuquerque, NM

• H. Cody Meissner, MD, Tufts University School of Medicine, Tufts Medical Center, Boston, MA

• Larry Pickering, MD, Emory University School of Medicine, Atlanta, GA

• Geeta Swamy, MD, Duke University, Durham, NC

Representative Members

• Timothy Cooke, PhD, NovaDigm Therapeutics Inc, Grand Forks, ND

• Leonard Friedland, MD, GSK Vaccines, Philadelphia, PA

National Vaccine Plan Development Subcommittee

Subcommittee Chairs

• Robert H. Hopkins Jr, MD, MACP, University of Arkansas for Medical Sciences, Little Rock, AR

• Geeta Swamy, MD, Duke University, Durham, NC

NVAC Members

• James S. Blumenstock, MA, Association of State and Territorial Health Officials, Arlington, VA

• John M. Douglas Jr, MD, National Association of County and City Health Officials, Greenwood Village, CO

• Kristen R. Ehresmann, RN, MPH, Association of Immunization Managers, St. Paul, MN

• Ann M. Ginsberg, MD, PhD, International AIDS Vaccine Initiative, Rockville, MD

• H. Cody Meissner, MD, Tufts University School of Medicine and Tufts Medical Center, Boston, MA

• Justin A. Mills, MD, MPH, Agency for Healthcare Research and Quality, Rockville, MD

• Barbara L. Mulach, PhD, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Rockville, MD

• Larry Pickering, MD, Emory University School of Medicine, Atlanta, GA

Public Members

• Abby Bownas, MA, Adult Vaccine Access Coalition, Washington, DC

• Bruce G. Gellin, MD, MPH, Sabin Vaccine Institute, Washington, DC

• Amy Nevel, MPH, Office of the Assistant Secretary for Planning and Evaluation, US Department of Health and Human Services, Washington, DC

• Walter A. Orenstein, MD, Emory University, Atlanta, GA

• Candice Swartwood, MPH, Centers for Disease Control and Prevention, Atlanta, GA

• Litjen (LJ) Tan, PhD, MS, Immunization Action Coalition, Chicago, IL

• Melinda Wharton, MD, MPH, National Center for Immunization and Respiratory Disease, Centers for Disease Control and Prevention, Atlanta, GA

Technical Advisors

• Thomas H. Acciani, PhD, Office of Infectious Disease and HIV/AIDS Policy, US Department of Health and Human Services, Washington, DC

• Ann Aikin, MA, Office of Infectious Disease and HIV/AIDS Policy, US Department of Health and Human Services, Washington, DC

• Ilka V. Chavez, MPA, Office of Infectious Disease and HIV/AIDS Policy, US Department of Health and Human Services, Washington, DC

Since the release of the 2010 NVP,¹ numerous scientific advances in vaccine research and development have led to the creation of new and improved vaccines. For example, in response to the 2014 Ebola outbreak in West Africa, federal and nonfederal partners collaborated to accelerate the development of promising Ebola vaccine candidates.¹¹ The Democratic Republic of the Congo, WHO, and several other partners¹² used one of these vaccines to vaccinate more than 158 830 persons¹³ against Ebola virus disease in affected health zones during 2 outbreaks in 2018 and 2019, the second-largest outbreak on record.¹⁴ Clinical data suggest that this vaccine is 97.5% effective in protecting persons at high risk of Ebola virus disease.¹³ In August 2019, the HHS Office of the Assistant Secretary for Preparedness and Response provided $23 million to increase production of this Ebola vaccine in the next year to aid in the international response and meet domestic biodefense goals.¹⁵ This vaccine is available for persons at risk for contracting Ebola virus disease in the Democratic Republic of the Congo during the ongoing outbreak, which began in August 2018.

Seasonal influenza is a public health challenge each year, with the last 2 seasons causing severe illness¹⁶ and the constant threat of an influenza pandemic. NVAC recommends further investment in improved influenza vaccines that are broad, durable, and highly effective. Annually, influenza viruses infect about 20% of the global population.¹⁷ Influenza is also associated with a substantial economic burden.¹⁸ For these reasons, improving influenza vaccines, their administration, and the infrastructure in place will increase their effectiveness, enhance vaccine safety, reduce health care costs, and improve health across the lifespan. By expanding influenza vaccine research, new influenza vaccines, and vaccine delivery systems, HHS can provide more choices for consumers. HHS has invested in greater pandemic preparedness by improving access to these vaccines and manufacturing techniques and increasing the amount of product for rapid distribution and widespread use. However, more investment in infrastructure will provide greater ability to respond rapidly to future pandemics and reduce the number and severity of illnesses associated with the influenza virus each year.

Access to immunization remains a challenging problem. In the 25 years since it was instituted, the Vaccines for Children program, a US government–funded program that provides recommended vaccines to children whose parents or guardians may not be able to afford vaccines, has improved childhood immunization rates.¹⁹ Furthermore, changes to reimbursement policy and expansions of health insurance coverage have also improved access to vaccination services, including access to adult vaccines. Despite these interventions, stark disparities in vaccine coverage rates among adults and adolescents persist among racial/ethnic minority groups and in rural areas. For example, black, Hispanic, and Asian adults had lower rates for all recommended vaccines than white adults.²⁰ In addition, black and Hispanic health care professionals are vaccinated less frequently than their white health care counterparts against influenza, hepatitis B, and tetanus, diphtheria, and pertussis.²⁰ Fewer adolescents in rural areas than in urban areas are fully vaccinated with human papillomavirus and meningococcal conjugate vaccines.²¹ In the next 30 years, the US population will become older, more diverse, and more suburban and urban than in previous decades.²² As US demographic characteristics shift, the problems of access to vaccination may become even more prominent than they are today.

Globally, vaccination prevents 2 to 3 million deaths every year, and WHO estimates that increased vaccination rates would avert another 1.5 million deaths.²³ Realizing the full promise of immunization requires a strong vaccine infrastructure. The NVP provides stakeholders (ie, policy makers, vaccine providers, and public health professionals) with a vision for this enterprise and a path for aligning efforts to address existing and evolving needs of the US immunization system.

National Vaccine Plan Background

In 1986, the Public Health Service Act §300aa–et seq created the NVP to enhance federal and nonfederal coordination of immunization-related activities and prevent human infectious diseases through immunization. This act called on HHS to develop a strategic plan to “establish priorities in research and the development, testing, licensing, production, procurement, distribution, and effective use of vaccines; describe the optimal use of resources to carry out such priorities; and describe how each of the various departments and agencies will carry out their vaccine functions.”²⁴

In accordance with this statute, HHS developed several plans that provide strategic direction for the US vaccine and immunization system. HHS issued the first NVP²⁵ in 1994. In 2010, HHS released the most recent version of the plan, which provided a 10-year vision for unifying and strengthening all aspects of the vaccine and immunization enterprise through 5 overarching goals and supporting objectives and strategies.¹ The 2010 NVP called for a midcourse review, which HHS³ and NVAC⁴ conducted in 2015 and 2016, respectively, to identify areas of opportunity for advancing the vaccine and immunization enterprise and to evaluate and define priorities to guide near-term implementation activities from 2016 to 2020. In addition, in response to a critical need to improve adult vaccination rates, HHS released the NAIP in 2016.² Both the NVP and the NAIP provide strong visions for the US vaccine and immunization system, and the updated 2020 NVP presents an opportunity to merge these plans and provide a comprehensive strategy for vaccination across the lifespan in the next 5 years.

Charge

To prepare for the updated NVP, the ASH charged NVAC with reviewing the goals and objectives of the current NVP, the midcourse reviews conducted by the National Vaccine Program Office (now the OIDP), and the NAIP and requested the following:

1. Combine the goals from the NVP and NAIP to generate a set of comprehensive prioritized goals that reflect immunization priorities across the lifespan.

2. Propose new goals as determined necessary for inclusion in the NVP and an appropriate rationale for each proposed goal.

3. Prioritize the 3 top objectives within each NVP goal, or proposed goal, poised to make the greatest impact on the US immunization system in the next few years.

4. Identify new stakeholders to engage during plan development who reflect the expertise and priorities of all stakeholders working to optimize the vaccination system in the United States.

5. Develop a report (of <10 pages) encompassing these recommendations for vote during the September 2019 NVAC meeting.

Process and Discussion

In response to this charge, NVAC established the NVP Development Subcommittee, which comprised NVAC members, several individuals in the private sector with relevant expertise, and HHS staff members. The subcommittee reviewed 6 plans, including the NVP,¹ the NVP Implementation Guide,²⁶ the Midcourse Review of the 2010 NVP,³ the evaluation of the 2010 NVP midcourse review,⁴ the NAIP,² and implementation of the NAIP.²⁷ The subcommittee worked together to reach consensus on all recommendations in this report in group meetings, through email discussions, and in final reviews of various parts of this report, as well as the full report.

To integrate goals of the NVP and the NAIP, the subcommittee discussed the feasibility of each goal and considered the following questions:

1. Are the goals still relevant?

2. Should HHS change the wording of the goals, add new goals, or remove goals?

3. Do the goals reflect a lifespan approach?

The subcommittee agreed that each of the 5 NVP goals was still descriptive of the immunization system and critical to its function. Yet the subcommittee identified several areas for improvement within each goal, briefly described here.

• Goal 1: Develop new and improved vaccines: The subcommittee recognized the need to incorporate related vaccine technologies, such as advances in cold-chain storage or new delivery systems, into the description of this goal area, as these advances are not reflected in the 2010 NVP goal.

• Goal 2: Enhance the vaccine safety system: The subcommittee recognized that the United States has a strong, robust system in place to monitor the safety of vaccines and agreed that this goal remains relevant to ensure continued success in vaccine safety and against new safety concerns. The subcommittee also recognized that the safety system must remain responsive to these changes. Therefore, only slight changes were made in goal wording to reflect the strong system in place.

• Goal 3: Support communications to enhance vaccine decision-making: The subcommittee agreed that this goal needed to be broadened to better account for the proliferation of online misinformation and to encourage better understanding of, and confidence in, routine vaccines and the immunization system.

• Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the United States: The subcommittee agreed to combine goals from the NVP and NAIP to include a lifespan approach to access, supply, and use of recommended vaccines, as well as enhance our manufacturing capabilities with more flexible and scalable platforms.

• Goal 5: Increase global prevention of death and disease through safe and effective vaccination: The subcommittee recognized the need to prevent the global spread of infectious disease and determined that this goal was still relevant.

The subcommittee also discussed adding new goals to the plan. One example was adding a goal on immunization infrastructure, given its importance at the federal, state, and local levels. A new goal on infrastructure would encompass strengthening vaccination practices in both the public and private sectors, assessing the impact of immunization programs through disease surveillance, supporting outbreak investigation and control, and monitoring vaccine effectiveness and safety. However, the subcommittee ultimately agreed that such an infrastructure goal, rather than standing by itself as a new goal, should be a priority objective within the rewritten Goal 4 (Table 2). The subcommittee also discussed adding a biodefense goal; however, the subcommittee recognized that the National Biodefense Strategy³⁰ serves the need of integrating biodefense into the HHS strategic vision, and an additional goal in the NVP was not needed.

Table 2.

Recommended 2020 National Vaccine Plan goals, with rationale, and top 3 priorities for each goal

Goal	Rationale	Top 3 Priorities
Goal 1: Foster innovation in vaccine development and related technologies.	Innovation in vaccine development, storage, production, and delivery has led to the eradication of once common diseases in the United States and the prevention of ongoing threats to public health. Development of vaccines and tools to immunize patients more effectively against infectious diseases remains an essential goal to ensure optimal public health. Promising vaccines in development include universal influenza vaccine and vaccines to prevent Zika infection.	Prioritize the development of innovative vaccines to prevent infectious diseases of patient and population health significance. Enhance systems for vaccine production, storage, and delivery. Identify and optimize current vaccines in need of improved effectiveness.
Goal 2: Continue to leverage the vaccine safety system.	The current vaccine safety system is robust, but continued development of tools and techniques to assess and improve safety and to communicate the evidence supporting the safety of recommended vaccines remains critical to successful immunization programs, public and provider acceptance, and implementation.	Sustain and enhance current tools, standards, and approaches used to assess vaccine safety. Develop new methods to rapidly and accurately assess the safety of all recommended vaccines. Disseminate lessons learned from the vaccine safety system.
Goal 3: Enhance knowledge of and confidence in routine vaccines and the immunization system.	Although vaccination to prevent infectious disease has been successful, hesitancy and misinformation about vaccines and vaccine-preventable diseases continue to thwart coverage rates. Effective strategies are needed to reach persons in disparate locations, with different backgrounds, and unique information needs. Providers, as trusted sources of information, need improved knowledge, skills, and abilities to accurately explain vaccine safety and address a range of questions, values, and information related to improving vaccine confidence.	Research effective communication strategies to reach underimmunized populations and address vaccine hesitancy, including messaging, outreach strategies, and cultural and linguistic approaches. Unify and promote vaccination standards28,29 across the lifespan. Enhance the delivery of vaccine safety and effectiveness messages to providers and the public.
Goal 4: Optimize access to and utilization of all routinely recommended vaccines across the lifespan.	Noteworthy disparities and gaps in immunization coverage remain, which place many persons at unnecessary risk from vaccine-preventable diseases. The NVAC adult, adolescent, and pediatric vaccination standards should be adapted to improve vaccination uptake across the lifespan.	Eliminate geographic, racial/ethnic, and socioeconomic barriers to vaccine access across the lifespan and improve care through quality improvement initiatives. Increase the use of, and secure data exchange within, electronic health records and immunization information systems to collect and track immunization data, support clinical decision-making, assist with vaccine forecasting, and identify areas of need. Strengthen public, private, and community-based partnerships and the public health infrastructure to improve manufacturing capabilities and delivery of immunizations for routine use and for protection during outbreaks.
Goal 5: Promote global immunization.	Infectious diseases cross national borders, and our mobile society increases the risk for vaccine-preventable diseases to spread to unimmunized and underimmunized persons. US leadership in global immunization development and programming is critical to continue advances toward the elimination of vaccine-preventable diseases and to help reduce the spread of emerging infectious disease threats.	Improve global surveillance for vaccine-preventable diseases and track progress against goals. Support international vaccine research and development and delivery programs to ensure vaccines are available to address global disease prevention. Sustain partnerships to prepare for emerging diseases and ongoing vaccine-preventable disease challenges.

Overall, the subcommittee combined the 2010 NVP goals and the NAIP goals into a set of 5 new goals. For example, the subcommittee recognized a need to foster innovation in both vaccine development and related technologies that support vaccination across the lifespan. The subcommittee incorporated this need for innovation into Goal 1 (Table 1). Similarly, for Goal 4, the group combined NVP and NAIP goals to “optimize access to and utilization of all routinely recommended vaccines across the lifespan.” For Goal 3, the subcommittee recognized the need to address misinformation and “enhance knowledge of and confidence in routine vaccines and the immunization system.” After refining the goals, the subcommittee then identified the top 3 priorities for each updated goal along with rationales for inclusion of the 5 recommended goals (Table 2).

The recommended goals, rationale, and priorities were presented to the full NVAC on June 4, 2019. NVAC members discussed this work and received one public comment on the presented language. Discussion focused on how this report should be used to develop the next NVP, the kinds of partners that would be engaged in the development of the plan, and the metrics for measuring impact. After the June meeting, the subcommittee then focused on developing recommendations for stakeholder inclusion. This work and this report were presented and approved at the September 17, 2019, NVAC meeting.

Recommended Goals, Priorities, and Rationale

• Recommendation 1: The NVAC recommends that HHS keep 5 broad goals in the 2020 NVP to reflect the entire immunization system. After thorough review and discussion, NVAC recommends updating these goals, the rationale for goal inclusion, and the top 3 priorities for each goal that are poised to make the greatest impact on the US immunization system in the next 5 years.

These goals align with and relate to goals in previous plans, as well as previous recommendations from NVAC¹ (Table 1).

Stakeholder Engagement Recommendations

NVAC values stakeholder engagement in the development of national immunization strategies and plans. NVAC recognizes that HHS has a long history of working with federal and nonfederal partners to develop previous national vaccine plans^1,2,27 and other activities that provide an overarching strategic direction for the immunization enterprise. NVAC supports further engagement with a wide range of stakeholders in the development of the next NVP to build on the input collected during previous report development.

Policy makers set policies for organizations and government entities and can include professional associations or congressional staff members. Vaccine innovators and manufacturers include researchers and makers of vaccine and related technologies. Public health professionals protect and promote health and include health educators, epidemiologists, and leaders. Quality organizations assess clinical quality and patient satisfaction to improve the delivery of vaccinations. Academics study all facets of the immunization system. Patients include current and potential consumers of vaccines. The public consists of caregivers, families, and consumer advocacy groups. Providers give vaccines to patients and can include various clinical professionals, such as physicians, pharmacists, and nurses. Purchasers buy vaccines and related technologies and can include vaccine-purchasing groups that procure vaccines in bulk and distribute them to providers. Payers include insurers, Medicare and Medicaid, and others responsible for reimbursement for vaccination.

• Recommendation 2: To represent the entire vaccination system, NVAC recommends the engagement of stakeholders relevant to each goal of the NVP, as well as the priorities identified in Table 2. Stakeholders include patients, the public, providers, purchasers, payers, policy makers, vaccine innovators and manufacturers, academics,³¹ quality organizations, and public health professionals (Figure).

• Recommendation 3: NVAC recognizes the importance of reducing disparities in vaccination and therefore recommends that stakeholders representing populations at risk for vaccine-preventable disease be consulted in the development of the next NVP, with a focus on including underrepresented groups to address disparities that may prohibit vaccine coverage equally across the US population.

• Recommendation 4: NVAC ³² stresses the need for focused attention on adult and maternal vaccination and recommends engaging stakeholders focused on improving immunization across the lifespan.

• Recommendation 5: NVAC supports the National Biodefense Strategy and recommends that the ASH and the OIDP engage partners working to protect Americans from biological threats and those engaged in responding to current vaccine-preventable disease outbreaks to learn how the immunization system can better support response to disease threats.

Figure.

National Vaccine Plan (NVP) stakeholder engagement diagram. The recommended goals and priorities require coordination and collaboration across the entire immunization system and for each goal of the NVP. The National Vaccine Advisory Committee suggests engaging the 11 stakeholder groups. These groups were modified from “A New Taxonomy for Stakeholder Engagement in Patient-Centered Outcomes Research.”³¹

Conclusion

The US vaccine and immunization system is complex and continues to evolve, and a strategic, national vision is critically important. Therefore, NVAC supports HHS’s development of a nimble 5-year plan that reflects immunization priorities across the lifespan and addresses ongoing gaps and challenges in each goal of the NVP. NVAC intends for this report to provide HHS with valuable guidance in the development of the next NVP.