Immunization

U.S.
Department of Health & Human Ser vices
Protecting the Nation’s Health through Immunization

U.S. Department of Health & Human Ser vices
National Vaccine Plan

Implementation
Protecting the Nation’s Health Through Immunization
Table of Contents
Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Goal 1: Develop new and improved vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Goal 2: Enhance the vaccine safety system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Goal 3: Support communications to enhance

informed vaccine decision-making . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Goal 4: Ensure a stable supply of, access to and better use

of recommended vaccines in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Goal 5: Increase global prevention of death and disease

through safe and effective vaccination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Appendix: Cross-walk of Priorities to National Vaccine Plan Goals,

Objectives, and Strategies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
U.S. Department of Health & Human Services | National Vaccine Plan Implementation
Background
2010 National Vaccine Plan
The 2010 National Vaccine Plan1 provides strategic direction and coordination for the nation’s
immunization program. The scope of the Plan is broad, describes the end-to-end activities of the
National Vaccine Program, and addresses the range of vaccine and vaccine-related issues for the
United States (U.S.) and global communities. A ten-year horizon was set for the Plan to align with
Healthy People 2020 goals.
The Plan is built around five broad goals:
Goal 1: Develop new and improved vaccines.
Goal 2: Enhance the vaccine safety system.
Goal 3: Support informed vaccine decision-making.
Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the
United States.
Goal 5: Increase global prevention of death and disease through safe and effective vaccination.
For more information about the scope and vision for the National Vaccine Plan, please refer to the
Purpose and Background section of the 2010 National Vaccine Plan.
Implementation Plan Development and Structure

The National Vaccine Plan Implementation was developed by an interagency working group
representing U.S. Department of Health and Human Services (HHS) agencies involved in all
aspects of vaccines and immunizations. This working group additionally consulted with partner
government agencies outside of HHS, including the U.S. Agency for International Development,
the Department of Veterans Affairs (VA), and the Department of Defense (DOD). Individual
stakeholder input was obtained through a series of meetings, and is described further below.
The Implementation Plan follows the architecture of the National Vaccine Plan, is organized by
the five goals (above), and focuses on the objectives and strategies related to achieving the 10
priorities described in the Plan (following). These priorities were established with input from the
Institute of Medicine, the National Vaccine Advisory Committee, and the interagency working
group. They provide strategic action steps to ensure the national has a robust immunization
program. The priorities can relate to more than one goal in the National Vaccine Plan, but are
presented with the most relevant goal within the Implementation Plan.
1
http://www.hhs.gov/nvpo/vacc_plan/2010%20Plan/nationalvaccineplan.pdf
U.S. Department of Health & Human Services | National Vaccine Plan Implementation 5
National Vaccine Plan Priorities for Implementation
A. Develop a catalogue of priority vaccine targets of domestic and global health
importance. (Goal 1)
B. Strengthen the science base for the development and licensure of new vaccines.
(Goals 1 and 2)
C. Enhance timely detection and verification of vaccine safety signals and develop a vaccine
safety scientific agenda. (Goal 2)
D. Increase awareness of vaccines, vaccine-preventable diseases (VPDs), and the benefits/risks

of immunization among the public, providers, and other stakeholders. (Goal 3)
E. Use evidence-based science to enhance vaccine-preventable disease surveillance,

measurement of vaccine coverage, and measurement of vaccine effectiveness. (Goal 4)
F. Eliminate financial barriers for providers and consumers to facilitate access to routinely
recommended vaccines. (Goal 4)
G. Create an adequate and stable supply of routinely recommended vaccines and vaccines for
public health preparedness. (Goal 4)
H. Increase and improve the use of interoperable health information technology and electronic
health records. (Goal 4)
I. Improve global surveillance for vaccine-preventable diseases and strengthen global health
information systems to monitor vaccine coverage, effectiveness, and safety. (Goal 5)
J. Support global introduction and availability of new and under-utilized vaccines to prevent
diseases of public health importance. (Goal 5)
The 2010 National Vaccine Plan is a national, not federal, plan that acknowledges the many
areas where stakeholder actions are needed to achieve a specific goal. The activities that are
described in this Implementation Plan are those that will be undertaken by federal departments
and agencies for the years 2010-2015 in line with their respective missions to achieve the specific
objectives described for each goal. The scope of work outlined in the Implementation Plan will
depend on the availability of future funds and other resources.
Implementation Monitoring and Evaluation

The National Vaccine Program Office (NVPO) will regularly track and annually summarize progress
on achieving the goals and priorities in the National Vaccine Plan, identify areas where progress is
lagging, and propose corrective action where needed.
In 2015, a formal mid-course review of the 2010 National Vaccine Plan and Implementation will
be undertaken with guidance from the National Vaccine Advisory Committee. Results of the mid-
course review will guide the development of implementation plans for 2015-2020.
The Appendix cross-walks the goals, objectives, and strategies of the 2010 National Vaccine Plan
with the 10 priorities.
Stakeholder Input
In conjunction with the development of the National Vaccine Plan Implementation, NVPO worked
with the Association of State and Territorial Health Officials (ASTHO), the HHS Regional Offices, and
other partner organizations to convene a series of regional stakeholder meetings in the summer
and fall of 2011. These meetings provided a forum for stakeholders to give individual input on
best practice examples and barriers and challenges toward meeting the goals in the 2010 National
Vaccine Plan. Each meeting focused on specific topics or populations of interest for the region,
such as health information technology and immunization information systems, billing for vaccines,
and immunization issues for American Indians, Alaska Natives, and populations along the U.S.-
México border. The individual findings from these meetings have informed the development
of the National Vaccine Plan Implementation as partners work together to make progress in the
immunization enterprise, and will be described in a companion document published by ASTHO in
2012.
Goal 1: Develop new and improved vaccines
Vaccine development is a complex process that includes inputs from researchers, manufacturers,
regulators, the public health community, and purchasers. Vaccines are increasingly developed
through partnerships. These efforts have been successful at bringing new vaccines to licensure
for broad use. Through targeted investments in science and technology, hundreds of vaccine
candidates at various stages of maturity are now in the development pipeline.
Because vaccine development is time- and resource-intensive, establishing and understanding

priorities for development and fostering collaboration among stakeholders is essential in
addressing the challenges of developing new and improved vaccines.
In addition, expanding scientific knowledge, coupled with advances in biotechnology and

manufacturing platforms, provides many possibilities for new and improved vaccines. Continued
investments from all sectors will be increasingly important as technological opportunities expand
and the costs to develop, license, and deliver vaccines increases.
Priority A: Develop a catalogue of priority vaccine targets of domestic and

global health importance.
Timeframe Lead Agency Actions to be Performed
By the end NVPO NVPO will support the development of a framework to

of 2012 prioritize preventive vaccines and convene a workshop to
obtain input from key partners on this framework through
a contract with the Institute of Medicine (IOM).2
By the end NVPO NVPO will support the development of a methodology

of 2013 for identifying priority vaccine targets for domestic and
global health priorities through a contract with the IOM.
By the end NVPO NVPO will support the production of a catalogue of

of 2015 priority vaccine targets of domestic and international
importance through a contract with the IOM.
Priority B: Strengthen the science base for the development and licensure of
new vaccines .(continued).
Ongoing National NIH will fund a broad range of basic and clinical
through the Institutes of research studies on topics including mechanisms of
end of 2015 Health (NIH) host-pathogen interaction, host immune response, new
vaccine targets, and vaccines against bacterial, viral, and
parasitic microbes. Information about these projects
will be included on publicly available websites, such as
NIH RePORT3 (Research Portfolio Online Reporting Tools)
and ClinicalTrials.gov, as well as in scientific publications.
2
http://www.iom.edu/Activities/PublicHealth/VaccineTargets.aspx
3
http://report.nih.gov/
Priority B: Strengthen the science base for the development and licensure of
new vaccines (continued).
Beginning Assistant ASPR will support the advanced development of next-

in 2006 and Secretary for generation cell-based and recombinant influenza
ongoing Preparedness vaccines with the goal of making more influenza vaccine
and Response available faster during influenza pandemics.
(ASPR)
Beginning in ASPR ASPR will coordinate and support efforts to optimize

2011 production and testing of influenza vaccines with the
goal of decreasing the time needed to make vaccine
available in an influenza pandemic.
Beginning Food and Drug FDA will develop and implement a research agenda
in 2011 and Administration that focuses on expanding the development of
annually (FDA) applied research with the goal of enhancing the safety
thereafter and effectiveness of vaccines and facilitate product
development.
By the end of ASPR ASPR will fund cooperative agreements with U.S.-based
2012 universities to support Advanced Biomanufacturing
Training Programs for scientists from manufacturers in
developing countries.
By the end of ASPR ASPR will fund development of clinical trial and
2013 laboratory infrastructure in developing countries for the
evaluation of candidate influenza vaccines in preclinical
research.
By the end of NIH NIH will fund product development research on 15

2015 vaccines for infectious diseases and related conditions.
By the end of NIH NIH will evaluate five new formulations/technologies

2015 with potential to improve vaccine immunogenicity,
safety, delivery, and/or dosing.
By the end of NIH NIH will fund preclinical services for investigators to
2015 develop and evaluate five candidate vaccines.
By the end of NIH NIH will fund multifunctional clinical research sites to
2015 expand the range of studies conducted among diverse
populations in the U.S. and international settings.
10 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
Goal 2: Enhance the vaccine safety system.
The U.S. has a robust vaccine safety system. The goal of this system is to identify in a timely
manner and minimize the occurrence of adverse events from vaccines. Past successes and
challenges offer insights into areas where the existing vaccine safety system can be enhanced.
Advances in information technology enhance the ability to conduct active surveillance.
Improvements in the understanding of immunology and genomics create opportunities to better
comprehend the immune response and biological mechanisms important for understanding the
safety of vaccines.
Vaccine safety science is often challenging because it may require studying very rare, but serious
outcomes. New tools have been developed that help detect and quantify rare events, elucidate
biological mechanisms and subpopulations at increased risk for adverse events, and help address
these scientific challenges.
Priority B: Strengthen the science base for the development and licensure
of new vaccines.
Beginning FDA FDA will develop and implement a research agenda

in 2011 and focusing on enhancement of vaccine safety evaluation;
annually including laboratory research, bioinformatics for
thereafter exchanging information, overseeing the safety of vaccine
products, and new epidemiological methods.
By the end NIH NIH will fund preclinical and clinical research related
of 2015 to the development of safe and effective vaccines,
including studies among healthy adults as well as specific
populations such as infants and children, the elderly, and
people with weakened immune systems.
Priority C: Enhance timely detection and verification of vaccine safety signals and
develop a vaccine safety scientific agenda.(continued).
Timeframe Lead Agency/ies Actions to be Performed
Beginning NVPO NVPO will fund a literature review of vaccine safety

in 2012 to inform development of a vaccine safety scientific
agenda.
By the end Federal The ISTF will increase the number of infants, children,
of 2012 Immunization adolescents, and adults enrolled in active surveillance
Safety Task Force systems for adverse events following immunizations
(ISTF): CDC, FDA, [e.g., Vaccine Adverse Events Reporting System (VAERS),
VA, Indian Health VA, IHS, DOD] in the U.S. to 90 million.
Service (IHS), and
DOD
develop a vaccine safety scientific agenda (continued).
By the end FDA FDA will contract with private health care data systems
of 2012 to access claims based information for vaccine safety
surveillance in the Post-licensure Rapid Immunization
Safety Monitoring (PRISM) program under FDA’s Mini-
Sentinel initiative. This will allow FDA to assess whether
vaccine exposure might be associated with health
outcomes of interest.
By the end FDA and Centers FDA and CMS will monitor the safety of seasonal
of 2012 for Medicare and influenza vaccines in Medicare beneficiaries using
Medicaid Services Medicare databases.
(CMS)
Beginning ISTF The ISTF will use the information from the NVPO-funded
in 2013 literature review of vaccine safety and develop a vaccine
safety scientific agenda. (This item is related to Priority
C, Action Item 1.)
By the end ISTF The ISTF will increase the number of infants, children,
of 2013 adolescents, and adults enrolled in active surveillance
systems for adverse events following immunizations
[e.g., Vaccine Adverse Events Reporting System (VAERS),
VA, IHS, DOD] in the U.S. to 100 million. (This item is
related to Priority C, Action Item 2.)
By the end Centers for CDC will redesign the online electronic reporting
of 2013 Disease Control form for the Vaccine Adverse Events Reporting System
and Prevention (VAERS) to include new fields that capture additional
(CDC) demographic information and implement web-based
features to expedite complete and accurate online
reporting.
By the end FDA and CDC FDA and CDC will enhance reporting by improving
of 2015 the ability to submit reports to VAERS electronically, to
facilitate efficient, complete, and accurate reporting of
adverse events following immunization.
By the end CDC CDC will conduct research and development for
of 2015 technologies to facilitate reporting to VAERS from
hand held devices such as application software and to
incorporate technologies into electronic health records
to facilitate VAERS reporting, such as provider prompts.
develop a vaccine safety scientific agenda (continued).
By the end FDA FDA will take steps toward providing patients, providers,
of 2015 and manufacturers with a single reporting portal for
adverse events by recommending VAERS data structure
modifications to allow compatibility with adverse event
reporting systems used for other medical products.
By the end CDC CDC will ensure that health plans with the capacity
of 2015 to rapidly and regularly provide complete, privacy-
protected medical records and chart review data for
immunization participate in vaccine safety surveillance
through the Vaccine Safety Datalink (VSD).
By the end CDC CDC will support VSD contractors in rapid assessments
of 2015 of all vaccine safety signals of significance.
By the end FDA and CDC FDA and CDC will receive manufacturer reports of
of 2015 vaccine adverse events electronically in accordance with
International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for
Human Use (ICH) E2B(R3) standards.
Goal 3: Support communications to enhance informed vaccine
decision-making
Vaccines have the unique quality of protecting both individuals and communities. However, given
their effectiveness and wide use for many years in preventing and eliminating a number of serious
infectious diseases, their significant contributions to public health may have faded from public
consciousness.
A myriad of enhanced tools are available for communicating accurate information about the
effectiveness and safety of the vaccines that we use. Communication tools and channels used
to disseminate immunization and vaccine information span a broad spectrum: publication of
evidence-based recommendations; use of mass media and new media; provider education
and training; and support of partner organizations and state immunization programs through
provision of resources, trainings, updates, and announcements.
Communications materials target many audiences including the public, health care providers
and media with timely and accurate information about the safety of vaccines. Communication
materials come in a variety of formats, including talking points or key messages, summaries of
scientific articles, Web content (e.g., notices to clinicians, fact sheets for consumers), clinician
videos, as well as responses to media and public inquiries. Cultural and linguistic appropriateness
for the intended audience are also considered in the development of communications materials,
as well as their accessibility to persons with disabilities.
Priority D: Increase awareness of vaccines, vaccine-preventable diseases,

and the benefits/risks of immunization among the public, providers, and
other stakeholders .(continued).
Beginning FDA FDA will enhance communication to stakeholders by

in 2011 and utilizing social media (including Twitter) to distribute
ongoing FDA-specific news and content about vaccines (e.g.,
new approvals, safety issues, etc).
By the end of NVPO NVPO will launch a comprehensive government

2011 website on vaccines and immunization.
Beginning in Office of ONC will promote consumer engagement projects to

2012 the National allow parents access to vaccination history data from
Coordinator for immunization information systems, including clinical
Health Information decision support tools.
Technology (ONC)
By the end of NVPO NVPO will launch a Spanish language comprehensive

2012 government website on vaccines and immunization.
Priority D: Increase awareness of vaccines, vaccine-preventable diseases,
and the benefits/risks of immunization among the public, providers, and
other stakeholders (continued).
By the end of FDA FDA will use specified metrics to evaluate use
2013 of Twitter as a means to communicate with
stakeholders.
By the end of CDC CDC will assess the accessibility and usability of
2015 Vaccine Information Statements (VIS) for different
target audiences. CDC will use this information to
revise VIS as needed.
Goal 4: Ensure a stable supply of, access to, and better use of
recommended vaccines in the United States.
The incidence in the U.S. of most diseases against which children are routinely immunized is at
or near record-low levels, and infant and child vaccination rates are approaching or exceeding
record levels. However, coverage levels are below Healthy People 2020 targets for many vaccines
targeted to adolescents and adults, and substantial disparities exist among racial and ethnic
groups in adult and adolescent vaccination levels.
A robust vaccine delivery system relies on multiple interrelated components, including ensuring
a reliable and steady supply of vaccines in the U.S., where shortages of several commonly used
vaccines have occurred since 2000 (e.g., Haemophilus influenza type b, hepatitis A, and influenza).
Financial barriers and lack of health care access also contribute to vaccination disparities and need
to be addressed in strategies moving forward.
Strong public health surveillance to monitor and evaluate vaccine-preventable diseases (VPDs)
and the effectiveness of licensed vaccines provides the link between vaccination policy and health
outcomes. Such public health surveillance is a key component of strategies to overcome barriers
and improve use of existing vaccines.
Immunization information systems (IIS) and electronic health records (EHRs) may become
increasingly important components of immunization programs, allowing for better immunization
recordkeeping for children and adults.
Priority E. Use evidence-based science to enhance vaccine-preventable

diseases surveillance, measurements of vaccine coverage, and measurement
of vaccine effectiveness.(continued).
Ongoing CDC CDC will increase the number of virus specimens received
and characterized annually from global National Influenza
Centers for use in determining vaccine strain selection.
Ongoing CDC CDC will continue to monitor the number of indigenous

cases of paralytic polio, rubella, congenital rubella
syndrome, measles, Haemophilus influenza type b (Hib),
diptheria, tetanus, mumps, pertussis (in persons <7 years),
and varicella (in persons <18 years) to evaluate the impact
of vaccine policy and programs.
Beginning CDC Within one year of a disease becoming newly vaccine-

in 2012 and preventable CDC will implement a plan for documenting
ongoing and reporting vaccine impact.
Beginning CMS CMS will track and publicly report the percentage of
in 2012 and nursing home residents that are assessed and appropriately
annually given influenza vaccine.
thereafter
Priority E. Use evidence-based science to enhance vaccine-preventable
diseases surveillance, measurements of vaccine coverage, and measurement
of vaccine effectiveness (continued).
By the end CDC CDC will increase the number of public health laboratories
of 2013 monitoring influenza virus resistance to antiviral agents to
15.
By the end CDC CDC will increase the percentage of Pandemic Influenza
of 2015 Collaborative Agreement grantees (state, local, territorial,
and tribal project areas) that meet the standard for
surveillance and laboratory capability criteria.
Priority F: Eliminate financial barriers for providers and consumers to facilitate access
to routinely recommended vaccines.
Beginning NVPO NVPO will provide an annual update to the

in 2010 and National Vaccine Advisory Committee on progress
annually toward strengthening and improving the vaccine
thereafter financing system in the U.S. to facilitate access to
routinely recommended vaccines.
Beginning Health Resources HRSA will measure the percentage of children

in 2012 and and Services seen at HRSA-funded health centers who receive
annually Administration (HRSA) all-age appropriate routinely recommended
thereafter vaccines by their second birthday.
By the end CDC CDC will support 28 immunization grantees to

of 2013 develop plans and 14 immunization grantees
to implement plans to enable billing for vaccine
services provided by public health clinics.
Beginning CDC CDC will provide guidance to immunization

in 2013 grantees to not use Section 317 vaccines for
routine vaccination of fully-insured patients.
Section 317 is a discretionary federal program
distributed to the states to provide money
for vaccine purchase and to develop vaccine
infrastructure.
Priority G: Create an adequate and stable supply of routinely recommended vaccines
and vaccines for public health preparedness.
Ongoing CDC CDC will continue to track the status of vaccine supplied
in the U.S. and maintain a strategic national stockpile
of vaccines that are available to state and local health
departments during public health emergencies and when
local supplies are depleted or unavailable.
Ongoing ASPR ASPR will continue to support, through public-private

partnerships, the development of domestic influenza
vaccine manufacturing capacity to address seasonal and
pandemic influenza vaccine needs.
Beginning FDA FDA will convene/co-sponsor three scientific meetings to

in 2011 facilitate the development of an effective vaccine against
a number of preventable infectious diseases for which
there is not a vaccine currently available.
Priority H: Increase and improve the use of interoperable health information

technology and electronic health records (EHRs).
Beginning ONC ONC will certify national standards for EHRs to ensure that
in 2010 and eligible professionals and hospitals may be assured that the
annually systems they adopt are capable of performing the required
thereafter functions.
Beginning ONC ONC will collect information on barriers to implementing

in 2011 meaningful use requirements for immunization through the
CRM (Sales Force) tool. The CRM (Sales Force) is a milestone
management tool which tracks the progress of Regional
Extension Centers (RECs) towards meeting their goals
of enrolling providers and getting providers to achieve
meaningful use.
Beginning ONC ONC will perform surveys of select providers enrolled to

in 2012 and receive services from RECs to determine issues/barriers with
annually immunization information systems and compatibility with
thereafter EHRs.
By the end ONC ONC will register 100,000 primary care providers to receive
of 2012 services from RECs and ensure that 60 percent of those
have adopted the use of EHRs.
Goal 5: Increase global prevention of death and disease through safe
and effective vaccination.
In the era of global pandemics and mass travel, the public health of U.S. citizens is closely related to
disease prevalence in other countries. Even though many VPDs such as polio, measles, and rubella
have been eliminated in this country, the U.S. remains vulnerable to importations as long as these
diseases continue to persist elsewhere. Support for developing new vaccines to address diseases
in other countries and assisting with their immunization programs contributes toward providing
a domestic “umbrella of protection” and fulfilling the U.S. government’s broader commitment to
support global public health.
Success in global immunization requires action by a broad range of stakeholders involved in the
vaccine and immunization enterprise: research and development, regulation and manufacturing,
procurement, distribution and delivery, program implementation, and monitoring. The Pan
American Health Organization’s “revolving fund” and new partnerships such as the GAVI Alliance
have led to increased support for immunization worldwide, spurring introduction of new
vaccines in low income countries and expanded vaccination coverage. U.S. governmental and
non-governmental organizations have contributed to progress through vaccine research and
development, participation in multilateral and bilateral partnerships, technical assistance, and
program support.
Priority I: Improve global surveillance for vaccine-preventable diseases and

strengthen global health information systems to monitor vaccine coverage,
effectiveness, and safety.
Ongoing CDC CDC will continue to serve as a global reference lab for
polio, measles, and rubella.
By the end CDC CDC will provide surveillance and laboratory capacity to
of 2013 and monitor progress in reaching global polio eradication,
ongoing guide programmatic response, and implement the polio
eradication end-game strategy.
By the end CDC CDC will provide a descriptive report of progress on

of 2013 and immunization activities in the Field Epidemiology and
annually Laboratory Training Program.
thereafter
4
http://www.cdc.gov/globalhealth/FETP/
Priority J: Support global introduction and availability of new and under-utilized
vaccines to prevent diseases of public health importance .(continued).
Ongoing CDC CDC will continue to provide surveillance, laboratory, and

vaccine program implementation capacity to support
national decision-making on new vaccine introduction,
and to enable introduction of new vaccines including
pneumococcal vaccine, rotavirus vaccine, meningococcal
vaccine, and human papillomavirus vaccine in GAVI eligible
countries.
Beginning ASPR ASPR will provide financial and technical support for
in 2006 and the World Health Organization (WHO) Global Action
annually Plan to Increase Pandemic Influenza Vaccines, including
thereafter capacity building for vaccine production at developing
country manufacturers, royalty-free adjuvant production,
specialized training in advanced biomanufacturing skills,
and clinical/laboratory infrastructure building.
Beginning FDA FDA will develop and implement a research agenda to

in 2010 and facilitate the development of vaccines against tropical and
annually neglected diseases.
thereafter
Beginning FDA FDA will participate in international collaborative studies

in 2010 to establish and maintain international reference materials
and standards for biologics.
Beginning FDA FDA will help build regulatory capacity in developing

in 2010 countries, which may include training, participation in
WHO assessments, and other international activities.
By the end ASPR ASPR will provide technical support in vaccine

of 2015 manufacturing, including training on vaccine production,
analytical evaluation, laboratory techniques, and clinical
evaluation, to developing country manufacturers for
the WHO Global Action Plan to Increase Pandemic
Influenza Vaccines. This training may take place on-site
in developing countries and at established educational
institutions in the U.S.
Priority J: Support global introduction and availability of new and under-utilized
vaccines to prevent diseases of public health importance (continued).
By the end Office of OGA will provide policy and diplomatic support for the
of 2015 Global Affairs WHO Global Action Plan to Increase Pandemic Influenza
(OGA) Vaccines by co-organizing and facilitating workshops to
bring together supporting infrastructures in influenza
vaccine development in developing countries, including
ministers of health, ministers of finance, vaccine
manufacturers, non-governmental organizations,
regulatory authorities, and policy-makers.
By the end OGA OGA will facilitate development of new partnerships

of 2015 across HHS, across the U.S. government, and with other
international partners not previously engaged for support
of the WHO Action Plan to Increase Pandemic Influenza
Vaccines.
Note: ASPR’s technical assistance and OGA’s policy activities are collaborative and leverage support with
international stakeholders for in-country influenza vaccine manufacturing and adoption of influenza vaccine policies.
Appendix: Priorities for Implementation and Related National Vaccine Plan Goals,
Objectives, and Strategies 5(continued)
Priority Related Goal(s) Related Objectives and Strategies
A. Develop a catalogue of Goal 1: Develop new and improved vaccines

priority vaccine targets of
domestic and global health
Objective 1.1: Prioritize new vaccine targets of domestic and global public health
importance.
1.1.1 Develop and implement a process for prioritizing and
evaluating new vaccine targets of domestic and global public
health importance. This catalogue of vaccine targets (including
improved vaccines) should include an analysis of barriers to
development
1.1.2 Conduct and improve disease surveillance of existing
pathogens and optimize methods to detect new pathogens to
continuously inform the priorities for potential new vaccines
5
Priorities may relate to objectives and strategies within multiple National Vaccine Plan goals. Within the National Vaccine Plan, Implementation 2010-2015, priorities are presented the
most relevant goal.
25
26
Objectives, and Strategies (continued)
B. Strengthen the science Goal 1: Develop new and improved vaccines

base for the development and Goal 2: Enhance the vaccine safety system
licensure of new vaccines
Objective 1.2: Support research to develop and manufacture new vaccine candidates
and improve current vaccines to prevent infectious diseases.
1.2.1 Conduct and support expanded vaccine research to meet
medical and public health needs. Establish surveillance systems
or studies to better assess disease burden in specific target
populations including neonates, infants, children, older adults,
pregnant women, immunocompromised individuals, and other
at-risk individuals.
1.2.2 Advance research and development toward new and/or
improved vaccines that prevent infectious diseases and their
sequelae, including those that protect against emerging, re-
emerging, and important biodefense-related pathogens.
1.2.3 Advance the science of neonatal and maternal immunity
including immunization and the development of
immunological models to study maternal immunization and
effects on offspring.
1.2.5 Develop new approaches to vaccine manufacturing (e.g., rapid,
flexible, and cost-effective) to meet demands for efficient,
expandable vaccine production capacity while also meeting
needs related to other public health emergency threats such as
international emerging diseases.

Objective 1.3: Support research on novel and improved vaccine delivery methods.
1.3.1 Develop and evaluate new and improved alternate delivery
methods of vaccine administration to optimize the protective
immune response, safety, effectiveness, and/or efficiency (e.g.,
number of doses).
1.3.2 Expand knowledge regarding the induction and maintenance
of vaccine immune responses via different routes of
administration (e.g., mucosal surfaces).
Objective 1.4: Increase understanding of the host immune system.
1.4.1 Define the capacity and quality of innate and adaptive human
immune response to infections among diverse gender, ethnic,
racial, age (childhood, adolescence, and adulthood), and health
condition status (e.g., autoimmune compromised individuals)
populations in order to advance the understanding of immune
protection.
1.4.2 Gain a better understanding of how induction and recall of
immune memory may inform the development of vaccines
that provide life-long protection.
1.4.3 Support development of immunomodulators including
vaccine adjuvants that facilitate the appropriate cell-mediated
and antibody responses for protection against pathogens with
distinct effector requirements.
1.4.4 Expand knowledge of host-related factors that impact severity
of disease and vaccine-induced host immune response, and
use this information to inform vaccine development.
27
28

1.4.5 Develop a database of gene-expression and immunologic
responses to selected currently licensed vaccines with a focus
on signals that correlate with mechanism of action, protection,
safety, and adverse events. Utilize this compendium to inform
development of new candidate vaccines and adjuvants.
1.4.6 Study mucosal immunity following vaccination in order to
better understand vaccine mechanisms and to provide new,
potentially more relevant, correlates of protection against
respiratory, enteric, genital, and urinary pathogens.
Objective 1.5: Support product development, evaluation, and production techniques
of vaccine candidates and the scientific tools needed for their
evaluation.
1.5.1 Support applied research to develop rapid and cost-efficient
production, and optimize formulations and stability profiles of
currently available vaccines.
1.5.2 Support research on and development of more flexible and
agile approaches to product development, manufacturing
production techniques including multi-use technologies such
as platforms, and quality testing procedures (e.g., potency and
safety testing).
1.5.3 Improve access to pilot lot manufacturing facilities that
produce clinical grade material for evaluating promising
vaccine candidates.
1.5.4 Support translational research that accelerates the
development of information that can be used in the evaluation
and licensure process.

1.5.5 Establish and strengthen public and private partnerships to
address urgent needs in vaccine research and development.
Objective 1.6: Improve the tools, standards, and approaches to assess the safety,
efficacy, and quality of vaccines.
1.6.1 Improve assay development for characterization of novel cell
substrates.
1.6.2 Improve efforts to develop, refine, and validate new biomarkers
and correlates of immunity.
1.6.3 Develop and improve methods to better assess vaccine
efficacy and safety including assessment of new technologies
and development of better animal models.
1.6.4 Improve methods for assessing and evaluating vaccine quality,
potency, safety, and effectiveness.
Objective 2.1: Ensure a robust vaccine safety scientific system that focuses on high
priority areas.
2.1.1 Develop, prioritize, and regularly update a national vaccine
safety scientific agenda.
2.1.2 Retain current and recruit additional highly trained vaccine
safety scientists and clinicians.
2.1.3 Improve laboratory, epidemiological, and statistical methods
used in Vaccine safety research.
Objective 2.2: Facilitate the timely integration of advances in manufacturing sciences
and regulatory approaches relevant to manufacturing, inspection, and
oversight to enhance product quality and patient safety.
29
30

2.2.1 Facilitate the enhancement of vaccine manufacturing sciences
and quality systems, including production technologies,
in-process controls and testing, and identification of best
practices in preventive quality systems and oversight.
2.2.2 Develop, implement, and periodically reassess risk-based
scientific approaches to identify inspectional priorities and best
practices.
2.2.3 Develop new scientific methods for both industry and the
Food and Drug Administration (FDA) for product quality
testing.
2.2.4 Assure that regulations, guidance documents, policies, and
procedures that are relevant to vaccine manufacturing,
laboratory testing, and quality control incorporate the most
current relevant scientific information to promote and enhance
product safety.
C. Enhance timely detection Goal 2: Enhance the vaccine safety system

and verification of vaccine
safety signals and develop a
vaccine safety scientific agenda
Objective 2.1: Ensure a robust vaccine safety scientific system that focuses
on high priority areas.
2.1.1 Develop, prioritize, and regularly update a national vaccine
safety scientific agenda.
2.1.2 Retain current and recruit additional highly trained vaccine
safety scientists and clinicians.
2.1.3 Improve laboratory, epidemiological, and statistical methods
used in vaccine safety research.
Objective 2.3: Enhance timely detection and verification of vaccine safety signals.
2.3.1 Improve the effectiveness and timeliness of signal identification
and assessment through coordinated use of passive and active
surveillance systems, and from providers and the public.
2.3.2 Improve the process for assessing adverse event following
immunization (AEFI) signals to determine which signals should
be evaluated further in epidemiological and clinical studies.
31
32

Objective 2.4: Improve timeliness of the evaluation of vaccine safety signals, especially
when 1) a high-priority new vaccine safety concern emerges or 2) when
a new vaccine is recommended, vaccination recommendations are
expanded, or during public health emergencies such as in an influenza
pandemic or other mass vaccination campaign.
2.4.1 Expand collaboration with clinical, laboratory, genetic,
statistical, and bioinformatics experts to conduct clinical
research studies to investigate the role of host genetics in
AEFIs.
2.4.2 Increase the size, representativeness, and utility of the
population under active surveillance for serious AEFIs that
can be included in timely, high quality, rigorously conducted
epidemiological studies to assess vaccine safety questions.
Objective 2.5: Improve causality assessments of vaccines and related AEFIs.
2.5.1 Build upon new scientific developments in areas such as
genetics, systems biology and bioinformatics, and immunology
to develop and validate tools which aid in (or enable) the
identification of individual risk factors for AEFIs for which a
causal relationship has been established.
2.5.2 Assess the evidence for a causal relationship between certain
vaccines and specific clinically important AEFIs and, as the
need arises, conduct an independent review of available
evidence.
Objective 2.6: Improve scientific knowledge about why and among whom vaccine
adverse reactions occur.

2.6.1 Identify host risk factors that may be associated with increased
risk for specific vaccine adverse reactions through basic, clinical,
or epidemiological research.
2.6.2 Identify the biological mechanism(s) for vaccine adverse
reactions.
2.6.3 Assess whether the risk of specific AEFIs is increased in specific
populations such as pregnant women, premature infants, older
adults, those with immunocompromising or other medical
conditions, based on gender or race/ethnicity, or other at-risk
individuals.
2.6.4 Develop a robust system to enhance collection of medical
histories and biological specimens from selected persons
experiencing serious AEFIs to enhance study of biological
mechanisms and individual risk factors.
Objective 2.8: Enhance collaboration of vaccine safety activities.
2.8.1 Improve collaboration, such as data sharing arrangements,
across federal agencies, departments, and with non-federal
partners.
2.8.2 Improve information and data sharing with international
partners (e.g., national vaccine safety programs) consistent with
ethical and human subjects protections and applicable law,
including confidentiality protections.
33
34

2.8.3 Develop additional standard case definitions for AEFIs for use
in immunization safety surveillance and research, vaccine
safety standards such as concept definitions, standardized
abbreviations, and standardized study designs.
D. Increase awareness of Goal 3: Support informed vaccine decision-making

vaccines, vaccine-preventable
diseases, and the benefits/risks
of immunization among the
public, providers, and other
stakeholders
Objective 3.1: Utilize communication approaches that are based on ongoing research.
3.1.1 Conduct research regularly to understand the public’s
knowledge, beliefs, and concerns about vaccines and VPDs.
3.1.2 Conduct research on factors that affect decision-making about
vaccination for individuals and families, providers, and policy-
makers.
3.1.3 Identify, develop, and test educational strategies that better
enable policy-makers to read, understand, and use information
about vaccine benefits and risks.
3.1.4 Evaluate the effectiveness of messages and materials in
addressing the information needs and concerns of the public
and under-immunized populations.

3.1.5 Develop evidence-based tools to assist individuals, parents,
and providers with relevant information to make informed
decisions regarding vaccination.
Objective 3.2: Build and enhance collaborations and partnerships for communication
efforts.
3.2.1 Strengthen existing partnerships and coalitions and
build relationships with new partners to support relevant
immunizations across the lifespan.
3.2.2 Use cross-agency and intra-agency collaboration to inform
development of communication research agendas, protocols,
campaigns and messages.
3.2.3 Collaborate with partners and stakeholders to communicate
vaccine benefits, risks, and recommendations in accessible
formats and in culturally appropriate languages, methods, and
literacy levels.
3.2.4 Utilize state and local venues to educate on vaccine and
immunization issues to expand the reach of messages outside
of the traditional clinical setting.
Objective 3.3: Enhance delivery of timely, accurate, and transparent information to
public audiences and key intermediaries (such as media, providers, and
public health officials) about what is known and unknown about the
benefits and risks of vaccines.
3.3.1 Enhance communication of new findings about vaccine
effectiveness, safety, and administration studies to the public,
partners and providers in a clear, transparent and timely
manner.
35
36

3.3.2 Respond in a rapid, coordinated, consistent, and effective
manner to emerging vaccine issues and concerns (e.g., supply,
safety, or public health emergencies).
3.3.3 Rapidly and effectively disseminate communications research
findings through peer-reviewed journals, conferences, media,
and partner communications to facilitate implementation of
evidence-based strategies.
Objective 3.4: Increase public awareness of the benefits and risks of vaccines
and immunization, especially among populations at risk of under-
immunization.
3.4.1 Develop, implement, and evaluate a long-term strategic
communications plan and program aimed at educating
parents, caregivers of children, adolescents, and adults
about VPDs; the benefits and risks of vaccines; and vaccine
recommendations.
3.4.2 Maintain current, easily accessible, evidence-based online
information on VPDs and vaccines, including benefits and
risks and the basis of immunization recommendations, for all
audience groups.
3.4.3 Evaluate new media (such as mobile technologies and social
media) and utilize it appropriately to reach target audiences
with accurate and timely information about vaccines and to
respond to emerging concerns and issues.
3.4.4 Enhance awareness of the importance of immunization as part
of preventive health care among parents, adolescents, and
adults.

3.4.5 Collaborate with the education community to assess
opportunities to integrate information on VPDs, recommended
vaccines, preventive health care, and public health in existing
educational curricula.
3.4.6 Develop and disseminate vaccine communication tools/
materials that are accessible and culturally and literacy-level
appropriate for groups at risk of under-immunization.
Objective 3.5: Assure that key decision- and policy-makers (e.g., third-party payers,
employers, legislators, community leaders, hospital administrators,
health departments) receive accurate and timely information on
vaccine benefits and risks; economics; and public and stakeholder
knowledge, attitudes, and beliefs.
3.5.1 Develop, disseminate, and evaluate broad-based education
tools for key groups on the value, risks, and cost-effectiveness
of vaccines; the basis of immunization recommendations;
business case evidence and guidance; vaccine policy
development; the standards of immunization practice and
administration; and vaccines as a component of preventive
health care.
3.5.2 Select and implement a model for sustained community
engagement to inform vaccine policy and program activities.
3.5.3 Provide vaccine program managers and policy-makers
information on the direct and indirect costs and benefits of
vaccination. This includes, but is not limited to, information on
federal and state programs that offer low-cost vaccines.
37
38

3.5.4 Provide policy-makers with data necessary to make informed
decisions on the utilization of vaccines in mass vaccination
programs for public health emergencies.
E. Use evidence-based science Goal 1: Develop new and improved vaccines

to enhance vaccine-preventable Goal 2: Enhance the vaccine safety system
disease surveillance,
Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the U.S.
measurement of vaccine
coverage, and measurement of
vaccine effectiveness
importance.
continuously inform the priorities for potential new vaccines.
1.2.1 Conduct and support expanded vaccine research to meet
medical and public health needs. Establish surveillance systems
or studies to better assess disease burden in specific target
populations including neonates, infants, children, older adults,
pregnant women, immunocompromised individuals, and other
at-risk individuals.

Objective 1.6: Improve the tools, standards, and approaches to assess the safety,
efficacy, and quality of vaccines.
1.6.1 Improve assay development for characterization of novel cell
substrates.
1.6.2 Improve efforts to develop, refine, and validate new biomarkers
and correlates of immunity.
1.6.3 Develop and improve methods to better assess vaccine
efficacy and safety including assessment of new technologies
and development of better animal models.
1.6.4 Improve methods for assessing and evaluating vaccine quality,
potency, safety, and effectiveness.
Objective 2.8: Enhance collaboration of vaccine safety activities.
2.8.1 Improve collaboration, such as data sharing arrangements,
across federal agencies, departments, and with non-federal
partners.
2.8.2 Improve information and data sharing with international
. partners (e.g., national vaccine safety programs) consistent with
ethical and human subjects protections and applicable law,
including confidentiality protections
2.8.3 Develop additional standard case definitions for AEFIs for use
in immunization safety surveillance and research, vaccine
safety standards such as concept definitions, standardized
abbreviations, and standardized study designs.
Objective 4.2: Ensure consistent and stable delivery of vaccines for the U.S.
39
40

4.2.7 Implement, monitor, and evaluate evidence-based
interventions designed to raise and sustain high vaccination
coverage across the lifespan.
4.2.8 Monitor and evaluate the impact of state immunization laws
and regulations on vaccine coverage, including childcare,
pre-school, school, college prematriculation requirements,
employer requirements, and the role of exemptions,
insurance mandates, and immunization information systems
requirements.
Objective 4.4: Maintain and enhance the capacity to monitor immunization coverage
for vaccines routinely administered to all age groups.
4.4.1 Identify, implement, and evaluate cost-effective and rapid
methods, such as the use of IIS or internet panel surveys,
for assessing vaccination coverage by categories, including
age groups, groups at risk of under immunization, by type of
vaccine, and type of financing.
4.4.2 Improve the completeness of, use of, and communication
between, IIS and EHR to monitor vaccination coverage.
4.4.3 Support the adoption of national certified, interoperable health
information technology and EHR for immunization.
4.4.4 Support and improve existing surveys assessing immunization
coverage (e.g., the National Immunization Survey and the
Behavioral Risk Factor Surveillance System), to include more
representative samples and timely reporting of data.

Objective 4.5: Enhance tracking of VPDs and monitoring of the effectiveness of
licensed vaccines.
4.5.1 Strengthen epidemiologic and laboratory methods and
tools to diagnose VPDs, assess population susceptibility,
and characterize vaccine effectiveness and the impact of
vaccination coverage on clinical and public health outcomes.
4.5.2 Monitor circulating strains of relevant vaccine-preventable
and potentially vaccine-preventable pathogens, including
emerging and re-emerging diseases.
4.5.3 Improve monitoring of disease burden and determine
epidemiologic and clinical characteristics of cases of VPDs and
potential VPDs by supporting traditional surveillance and use
of health information technology, interoperable data standards,
and new data resources.
4.5.4 Develop and maintain capacity to rapidly estimate the
effectiveness of new vaccines, such as pandemic and pre-
pandemic influenza vaccines.
4.5.5 Assure rapid and comprehensive identification, investigation,
and response to vaccine- preventable disease outbreaks.
4.5.6 Assure timely evaluation to assess vaccine effectiveness,
duration of protection, and indirect (community and herd)
protection by current and newly recommended vaccines.
41
42

Objective 4.9: Enhance immunization coverage for travelers.
4.9.1 Define the populations at risk for acquiring international
travel-related VPDs, and identify and address barriers to their
receiving immunizations.
4.9.2 Assess overall immunization status during travel-related
immunization clinics.
F. Eliminate financial barriers Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the U.S.
for providers and consumers
to facilitate access to routinely
recommended vaccines
Objective 4.3: Reduce financial barriers to vaccination.

4.3.1 Identify and regularly monitor financial barriers to receipt
of Advisory Committee for Immunization Practices (ACIP)-
recommended and CDC-adopted vaccines.
4.3.3 Strengthen the ability of states to purchase, and expand access
to, ACIP-recommended and CDC-adopted vaccines for those
who qualify for publicly supported vaccinations.
4.3.4 Develop, implement, and evaluate strategies to reduce the
financial burden on vaccination providers for purchase of initial
and ongoing vaccine inventories.
Objective 4.6: Educate and support health care providers in vaccination counseling
and vaccine delivery for their patients and themselves.

4.6.4 Promote and support educational and technical assistance
to improve business practices associated with providing
immunizations, such as educating providers and enrolling new
providers into the Vaccines for Children program, including
non-traditional providers.
4.6.6 Support adequate reimbursement for vaccine counseling,
administration, storage and handling by providers under public
sector and private health plans.
4.6.7 Support research to evaluate the capacity (accommodating
the increased number of patient visits required to receive
recommended vaccines) of health care providers to implement
vaccine recommendations for all age groups.
Objective 4.8: Strengthen the National Vaccine Injury Compensation Program (VICP)
and Countermeasures Injury Compensation Program (CICP).
4.8.3 Continue to ensure fair and efficient compensation for vaccine-
related injuries.
4.8.4 Examine alternative approaches, and evaluate and implement
those deemed optimal, for adjudication of VICP claims for
illnesses not included in the Vaccine Injury Table to the extent
permitted by applicable law.
43
G. Create an adequate and Goal 1: Develop new and improved vaccines

stable vaccine supply routinely Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the U.S.
recommended vaccines and
vaccines for public health
preparedness
1.2.5 Develop new approaches to vaccine manufacturing (e.g., rapid,
flexible, and cost-effective) to meet demands for efficient,
expandable vaccine production capacity while also meeting
needs related to other public health emergency threats such as
international emerging diseases.
evaluation.
1.5.1 Support applied research to develop rapid and cost-efficient
production, and optimize formulations and stability profiles of
currently available vaccines.
1.5.2 Support research on and development of more flexible and
agile approaches to product development, manufacturing
production techniques including multi-use technologies such
as platforms, and quality testing procedures (e.g., potency and
safety testing).

1.5.3 Improve access to pilot lot manufacturing facilities that
produce clinical grade material for evaluating promising
vaccine candidates.
1.5.4 Support translational research that accelerates the
development of information that can be used in the evaluation
and licensure process.
Objective 4.1: Ensure consistent and adequate supply of vaccines for the U.S.
4.1.1 Determine barriers to having multiple suppliers for each
vaccine licensed and recommended for routine use in the U.S.
4.1.2 Promote harmonization of international vaccine regulatory
standards for licensure.
4.1.3 Improve vaccine quality and availability through better
manufacturing and production oversight.
4.1.4 Optimize use, content, and distribution of vaccine stockpiles
and ancillary supplies.
4.1.5 Improve the development of, communication of, and tracking
of adherence to recommended changes in vaccine use during
national vaccine shortages.
licensed vaccines.
45
46

H. Increase the use of Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the U.S.
interoperable health
information and electronic
health records
Objective 4.4: Maintain and enhance the capacity to monitor immunization coverage
for vaccines routinely administered to all age groups.
4.4.1 Identify, implement, and evaluate cost-effective and rapid
methods, such as the use of IIS or internet panel surveys,
for assessing vaccination coverage by categories, including
age groups, groups at risk of under immunization, by type of
vaccine, and type of financing.
4.4.2 Improve the completeness of, use of, and communication
between, IIS and EHR to monitor vaccination coverage.
4.4.3 Support the adoption of national certified, interoperable health
information technology and EHR for immunization.
4.4.4 Support and improve existing surveys assessing immunization
coverage (e.g., the National Immunization Survey and the
Behavioral Risk Factor Surveillance System), to include more
representative samples and timely reporting of data.
Objective 4.6: Educate and support health care providers in vaccination counseling
and vaccine delivery for their patients and themselves.
47
48

4.6.2 Expand and implement training and education of
immunization providers at all levels of their education on
the proper use and administration of vaccines; the proper
storage and handling of vaccines; the basis of immunization
recommendations; the safety of vaccines; reporting of AEFIs;
understanding of the vaccine safety system; and on the
standards of immunization practice (e.g., vaccine education
modules in primary care and continuing medical education
programs).
4.6.5 Expand the incorporation of vaccinations and the use of IIS
into quality improvement programs such as the Healthcare
Effectiveness Data and Information Set.
I. Improve global surveillance Goal 4: Ensure a stable supply of, access to, and better use of recommended vaccines in the U.S.
for vaccine-preventable Goal 5: Increase global prevention of death and disease through safe and effective vaccination
diseases and strengthen global
health information systems
to monitor vaccine coverage,
effectiveness, and safety

licensed vaccines.
49
50

Objective 5.1: Support international organizations and countries to improve global
surveillance for VPDs and strengthen health information systems to
monitor vaccine coverage, effectiveness, and safety.
5.1.1 Achieve sustainable WHO certification quality surveillance for
eradication of targeted VPDs.
5.1.2 Expand and improve sustainable surveillance systems for all
diseases having WHO-recommended vaccines and diseases for
which vaccine introduction is being considered.
5.1.3 Strengthen all levels of global laboratory networks (including
national, regional, and global reference laboratories) to sustain
and improve VPD diagnosis in order to establish baseline
disease burden, detect outbreaks, detect newly emerging
variants of VPDs, and monitor the impact of new vaccines. This
laboratory capacity should also be developed for surveillance
of potential public health emergencies of international
concern.
5.1.4 Enhance assessments of emerging variants or strains of VPD
agents.
5.1.5 Develop new diagnostic tests, tools and procedures to improve
both field-based and laboratory confirmation of diagnoses.

Objective 5.2: Support international organizations and countries to improve and
sustain immunization programs as a component of health care delivery
systems and promote opportunities to link immunization delivery with
other priority health interventions, where appropriate.
5.2.1 Provide technical support to countries, multilateral institutions,
and other partners to strengthen key components of
immunization program management and implementation,
including epidemiological analysis, comprehensive planning,
vaccine distribution and safe administration, monitoring,
information systems, and program evaluation.
Objective 5.6: Build and strengthen multilateral and bilateral partnerships and other
collaborative efforts to support global immunization and eradication
programs.
5.6.1 Participate in establishing global immunization priorities, goals
and objectives and provide technical assistance at global,
regional, and national levels.
5.6.3 Contribute to development and implementation of a plan
establishing the scientific basis for VPD eradication/elimination,
identifying optimal vaccination approaches, and developing
strategies to minimize risks in the post-eradication period.
5.6.4 Participate in regional immunization initiatives, such as those

adopted by the Pan American Health Organization and other
WHO regions.
51
52
J. Support global introduction Goal 1: Develop new and improved vaccines

and availability of new and Goal 5: Increase global prevention of death and disease through safe and effective vaccination
under-utilized vaccines to
prevent diseases of public
health importance
importance.
1.1.1 Develop and implement a process for prioritizing and
evaluating new Vaccine targets of domestic and global public
health importance. This catalogue of vaccine targets (including
improved vaccines) should include an analysis of barriers to
development.
continuously inform the priorities for potential new vaccines.
Objective 1.2: . Support research to develop and manufacture new vaccine candidates
and improve current vaccines to prevent infectious diseases
Objective 1.3: Support research on novel and improved vaccine delivery methods.
evaluation.

Objective 5.3: Support international organizations and countries to introduce and
make available new and underutilized vaccines to prevent diseases of
public health importance.
5.3.1 Strengthen capacity at the country level, and in multilateral
institutions as appropriate, to make informed decisions
on introduction of new vaccines based on evaluation of
epidemiology, financial sustainability, safety, and programmatic
considerations, including support to national advisory
committees.
5.3.2 Collaborate with global organizations and partners to
accelerate clinical testing and licensure in developing countries
of vaccines already licensed in developed countries, where
appropriate.
5.3.3 Support the integration of new and underutilized vaccines
into each GAVI-eligible country’s multi-year national plan of
action and provide training and logistical support necessary to
successfully incorporate new vaccines into routine programs.
5.3.4 Support post-licensure evaluations of new vaccines with regard
to immunization programs, disease patterns, and vaccine
safety.
53
54

5.3.5 Work with global partners to establish an international system
that facilitates rapid response to emerging infections through
the development of vaccine reference strains and candidate
vaccines.
5.3.6 Work with global partners to secure and maintain adequate
stockpiles/strategic reserves of vaccines to maintain
uninterrupted supply and for emergency response to
outbreaks.
5.3.7 Support and develop mechanisms for rapidly making
vaccines available to developing countries for public health
emergencies such as pandemic influenza, including exploring
options for sharing of vaccines and tiered pricing.
Objective 5.5: Support the development of regulatory environments and
manufacturing capabilities that facilitate access to safe and effective
vaccines in all countries.
5.5.1 Promote and support the efforts of WHO and other global
partners to develop and harmonize international standards for
vaccine development and licensure.
5.5.2 Promote and support the efforts of WHO and others to
improve regulatory capacity in countries with limited
infrastructures to assure vaccine quality, evaluate new vaccines
when appropriate, and assure that clinical trials are conducted
in accordance with Good Clinical Practices.

5.5.3 Provide technical assistance to developing country vaccine
manufacturers to support development and production of safe
and effective vaccines.
Objective 5.6: Build and strengthen multilateral and bilateral partnerships and other
collaborative efforts to support global immunization and eradication
programs.
5.6.1 Participate in establishing global immunization priorities, goals
and objectives and provide technical assistance at global,
regional, and national levels.
5.6.2 Strengthen international collaborations for basic and applied
research and related training of next generation researchers,
especially in disease endemic areas, to include improving the
stability and performance of current vaccines.
5.6.3 Contribute to development and implementation of a plan
establishing the scientific basis for VPD eradication/elimination,
identifying optimal vaccination approaches, and developing
strategies to minimize risks in the post-eradication period.
5.6.4 Participate in regional immunization initiatives, such as those
adopted by the Pan American Health Organization and other
WHO regions.
5.6.5. Strengthen vaccination of globally mobile populations through
targeted programs (e.g., pre-departure vaccination of US
bound refugees).
55

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U.S.

Department of Health & Human Ser vices

Protecting the Nation’s Health through Immunization

National Vaccine Plan

Goal 1: Develop new and improved vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Goal 2: Enhance the vaccine safety system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Goal 3: Support communications to enhance

Goal 4: Ensure a stable supply of, access to and better use

Goal 5: Increase global prevention of death and disease

Appendix: Cross-walk of Priorities to National Vaccine Plan Goals,

The Plan is built around five broad goals:

Goal 1: Develop new and improved vaccines.

Goal 2: Enhance the vaccine safety system.

Goal 3: Support informed vaccine decision-making.

Implementation Plan Development and Structure

D. Increase awareness of vaccines, vaccine-preventable diseases (VPDs), and the benefits/risks

E. Use evidence-based science to enhance vaccine-preventable disease surveillance,

Implementation Monitoring and Evaluation

Because vaccine development is time- and resource-intensive, establishing and understanding

In addition, expanding scientific knowledge, coupled with advances in biotechnology and

Priority A: Develop a catalogue of priority vaccine targets of domestic and

Timeframe Lead Agency Actions to be Performed

By the end NVPO NVPO will support the development of a framework to

By the end NVPO NVPO will support the development of a methodology

By the end NVPO NVPO will support the production of a catalogue of

Timeframe Lead Agency Actions to be Performed

Timeframe Lead Agency Actions to be Performed

Beginning Assistant ASPR will support the advanced development of next-

Beginning in ASPR ASPR will coordinate and support efforts to optimize

By the end of NIH NIH will fund product development research on 15

By the end of NIH NIH will evaluate five new formulations/technologies

Timeframe Lead Agency Actions to be Performed

Beginning FDA FDA will develop and implement a research agenda

Timeframe Lead Agency/ies Actions to be Performed

Beginning NVPO NVPO will fund a literature review of vaccine safety

Timeframe Lead Agency/ies Actions to be Performed

Timeframe Lead Agency/ies Actions to be Performed

Priority D: Increase awareness of vaccines, vaccine-preventable diseases,

Timeframe Lead Agency Actions to be Performed

Beginning FDA FDA will enhance communication to stakeholders by

By the end of NVPO NVPO will launch a comprehensive government

Beginning in Office of ONC will promote consumer engagement projects to

By the end of NVPO NVPO will launch a Spanish language comprehensive

Timeframe Lead Agency Actions to be Performed

Priority E. Use evidence-based science to enhance vaccine-preventable

Timeframe Lead Agency Actions to be Performed

Ongoing CDC CDC will continue to monitor the number of indigenous

Beginning CDC Within one year of a disease becoming newly vaccine-

Timeframe Lead Agency Actions to be Performed

Timeframe Lead Agency Actions to be Performed

Beginning NVPO NVPO will provide an annual update to the

Beginning Health Resources HRSA will measure the percentage of children

By the end CDC CDC will support 28 immunization grantees to

Beginning CDC CDC will provide guidance to immunization

Timeframe Lead Agency Actions to be Performed

Ongoing ASPR ASPR will continue to support, through public-private

Beginning FDA FDA will convene/co-sponsor three scientific meetings to

Priority H: Increase and improve the use of interoperable health information

Timeframe Lead Agency Actions to be Performed