Protecting the Nation’s Health through Immunization · Protecting the Nation’s Health through...
Transcript of Protecting the Nation’s Health through Immunization · Protecting the Nation’s Health through...
National Vaccine PlanImplementation
Protecting the Nation’s Health Through Immunization
U.S. Department of Health & Human Services
U.S. Department of Health & Human Services | National Vaccine Plan Implementation
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 enhanceinformed 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 diseasethrough safe and effective vaccination 21
Appendix: Cross-walk of Priorities to National Vaccine Plan Goals, Objectives, and Strategies 25
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Background
2010 National Vaccine PlanThe 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 StructureThe 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
National Vaccine Plan Priorities for ImplementationA. 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 EvaluationThe 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.
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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 InputIn 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.
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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 of 2012
NVPO NVPO will support the development of a framework to 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 endof 2013
NVPO NVPO will support the development of a methodology for identifying priority vaccine targets for domestic and global health priorities through a contract with the IOM.
By the end of 2015
NVPO NVPO will support the production of a catalogue of 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).
Timeframe Lead Agency Actions to be Performed
Ongoing through the end of 2015
National Institutes of Health (NIH)
NIH will fund a broad range of basic and clinical research studies on topics including mechanisms of 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.aspx3 http://report.nih.gov/
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Priority B: Strengthen the science base for the development and licensure of new vaccines (continued).
Timeframe Lead Agency Actions to be Performed
Beginning in 2006 and ongoing
Assistant Secretary for Preparedness and Response (ASPR)
ASPR will support the advanced development of next-generation cell-based and recombinant influenza vaccines with the goal of making more influenza vaccine available faster during influenza pandemics.
Beginning in 2011
ASPR ASPR will coordinate and support efforts to optimize production and testing of influenza vaccines with the goal of decreasing the time needed to make vaccine available in an influenza pandemic.
Beginning in 2011 and annually thereafter
Food and Drug Administration (FDA)
FDA will develop and implement a research agenda that focuses on expanding the development of applied research with the goal of enhancing the safety and effectiveness of vaccines and facilitate product development.
By the end of 2012
ASPR ASPR will fund cooperative agreements with U.S.-based universities to support Advanced Biomanufacturing Training Programs for scientists from manufacturers in developing countries.
By the end of 2013
ASPR ASPR will fund development of clinical trial and laboratory infrastructure in developing countries for the evaluation of candidate influenza vaccines in preclinical research.
By the end of 2015
NIH NIH will fund product development research on 15 vaccines for infectious diseases and related conditions.
By the end of 2015
NIH NIH will evaluate five new formulations/technologies with potential to improve vaccine immunogenicity, safety, delivery, and/or dosing.
By the end of 2015
NIH NIH will fund preclinical services for investigators to develop and evaluate five candidate vaccines.
By the end of 2015
NIH NIH will fund multifunctional clinical research sites to expand the range of studies conducted among diverse populations in the U.S. and international settings.
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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.
Timeframe Lead Agency Actions to be Performed
Beginning in 2011 and annually thereafter
FDA FDA will develop and implement a research agenda focusing on enhancement of vaccine safety evaluation; including laboratory research, bioinformatics for exchanging information, overseeing the safety of vaccine products, and new epidemiological methods.
By the end of 2015
NIH NIH will fund preclinical and clinical research related 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 in 2012
NVPO NVPO will fund a literature review of vaccine safety to inform development of a vaccine safety scientific agenda.
By the end of 2012
Federal Immunization Safety Task Force (ISTF): CDC, FDA, VA, Indian Health Service (IHS), and DOD
The ISTF will increase the number of infants, children, 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 90 million.
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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
By the end of 2012
FDA FDA will contract with private health care data systems 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 of 2012
FDA and Centers for Medicare and Medicaid Services (CMS)
FDA and CMS will monitor the safety of seasonal influenza vaccines in Medicare beneficiaries using Medicare databases.
Beginning in 2013
ISTF The ISTF will use the information from the NVPO-funded 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 of 2013
ISTF The ISTF will increase the number of infants, children, 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 of 2013
Centers for Disease Control and Prevention (CDC)
CDC will redesign the online electronic reporting form for the Vaccine Adverse Events Reporting System (VAERS) to include new fields that capture additional demographic information and implement web-based features to expedite complete and accurate online reporting.
By the end of 2015
FDA and CDC FDA and CDC will enhance reporting by improving the ability to submit reports to VAERS electronically, to facilitate efficient, complete, and accurate reporting of adverse events following immunization.
By the end of 2015
CDC CDC will conduct research and development for 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.
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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
By the end of 2015
FDA FDA will take steps toward providing patients, providers, 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 of 2015
CDC CDC will ensure that health plans with the capacity 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 of 2015
CDC CDC will support VSD contractors in rapid assessments of all vaccine safety signals of significance.
By the end of 2015
FDA and CDC FDA and CDC will receive manufacturer reports of 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.
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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).
Timeframe Lead Agency Actions to be Performed
Beginning in 2011 and ongoing
FDA FDA will enhance communication to stakeholders by utilizing social media (including Twitter) to distribute FDA-specific news and content about vaccines (e.g., new approvals, safety issues, etc).
By the end of 2011
NVPO NVPO will launch a comprehensive government website on vaccines and immunization.
Beginning in 2012
Office of the National Coordinator for Health Information Technology (ONC)
ONC will promote consumer engagement projects to allow parents access to vaccination history data from immunization information systems, including clinical decision support tools.
By the end of 2012
NVPO NVPO will launch a Spanish language comprehensive government website on vaccines and immunization.
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Priority D: Increase awareness of vaccines, vaccine-preventable diseases, and the benefits/risks of immunization among the public, providers, and other stakeholders (continued).
Timeframe Lead Agency Actions to be Performed
By the end of 2013
FDA FDA will use specified metrics to evaluate use of Twitter as a means to communicate with stakeholders.
By the end of 2015
CDC CDC will assess the accessibility and usability of Vaccine Information Statements (VIS) for different target audiences. CDC will use this information to revise VIS as needed.
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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).
Timeframe Lead Agency Actions to be Performed
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 in 2012 and ongoing
CDC Within one year of a disease becoming newly vaccine-preventable CDC will implement a plan for documenting and reporting vaccine impact.
Beginning in 2012 and annually thereafter
CMS CMS will track and publicly report the percentage of nursing home residents that are assessed and appropriately given influenza vaccine.
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Priority E. Use evidence-based science to enhance vaccine-preventable diseases surveillance, measurements of vaccine coverage, and measurement of vaccine effectiveness (continued).
Timeframe Lead Agency Actions to be Performed
By the end of 2013
CDC CDC will increase the number of public health laboratories monitoring influenza virus resistance to antiviral agents to 15.
By the end of 2015
CDC CDC will increase the percentage of Pandemic Influenza 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.
Timeframe Lead Agency Actions to be Performed
Beginning in 2010 and annually thereafter
NVPO NVPO will provide an annual update to the National Vaccine Advisory Committee on progress toward strengthening and improving the vaccine financing system in the U.S. to facilitate access to routinely recommended vaccines.
Beginning in 2012 and annually thereafter
Health Resources and Services Administration (HRSA)
HRSA will measure the percentage of children seen at HRSA-funded health centers who receive all-age appropriate routinely recommended vaccines by their second birthday.
By the end of 2013
CDC CDC will support 28 immunization grantees to develop plans and 14 immunization grantees to implement plans to enable billing for vaccine services provided by public health clinics.
Beginning in 2013
CDC CDC will provide guidance to immunization 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.
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Priority G: Create an adequate and stable supply of routinely recommended vaccines and vaccines for public health preparedness.
Timeframe Lead Agency Actions to be Performed
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 in 2011
FDA FDA will convene/co-sponsor three scientific meetings to 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).
Timeframe Lead Agency Actions to be Performed
Beginning in 2010 and annually thereafter
ONC ONC will certify national standards for EHRs to ensure that eligible professionals and hospitals may be assured that the systems they adopt are capable of performing the required functions.
Beginning in 2011
ONC ONC will collect information on barriers to implementing 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 in 2012 and annually thereafter
ONC ONC will perform surveys of select providers enrolled to receive services from RECs to determine issues/barriers with immunization information systems and compatibility with EHRs.
By the end of 2012
ONC ONC will register 100,000 primary care providers to receive services from RECs and ensure that 60 percent of those have adopted the use of EHRs.
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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.
Timeframe Lead Agency Actions to be Performed
Ongoing CDC CDC will continue to serve as a global reference lab for polio, measles, and rubella.
By the end of 2013 and ongoing
CDC CDC will provide surveillance and laboratory capacity to monitor progress in reaching global polio eradication, guide programmatic response, and implement the polio eradication end-game strategy.
By the end of 2013 and annually thereafter
CDC CDC will provide a descriptive report of progress on immunization activities in the Field Epidemiology and Laboratory Training Program.
4 http://www.cdc.gov/globalhealth/FETP/
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Priority J: Support global introduction and availability of new and under-utilized vaccines to prevent diseases of public health importance (continued).
Timeframe Lead Agency Actions to be Performed
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 in 2006 and annually thereafter
ASPR ASPR will provide financial and technical support for the World Health Organization (WHO) Global Action Plan to Increase Pandemic Influenza Vaccines, including 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 in 2010 and annually thereafter
FDA FDA will develop and implement a research agenda to facilitate the development of vaccines against tropical and neglected diseases.
Beginning in 2010
FDA FDA will participate in international collaborative studies to establish and maintain international reference materials and standards for biologics.
Beginning in 2010
FDA FDA will help build regulatory capacity in developing countries, which may include training, participation in WHO assessments, and other international activities.
By the end of 2015
ASPR ASPR will provide technical support in vaccine 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.
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Priority J: Support global introduction and availability of new and under-utilized vaccines to prevent diseases of public health importance (continued).
Timeframe Lead Agency Actions to be Performed
By the end of 2015
Office of Global Affairs (OGA)
OGA will provide policy and diplomatic support for the WHO Global Action Plan to Increase Pandemic Influenza 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 of 2015
OGA OGA will facilitate development of new partnerships 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.
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ase
burd
en in
spec
ific
targ
et
popu
latio
ns in
clud
ing
neon
ates
, inf
ants
, chi
ldre
n, o
lder
adu
lts,
preg
nant
wom
en, i
mm
unoc
ompr
omise
d in
divi
dual
s, an
d ot
her
at-r
isk in
divi
dual
s. 1.
2.2
Adva
nce
rese
arch
and
dev
elop
men
t tow
ard
new
and
/or
impr
oved
vac
cine
s tha
t pre
vent
infe
ctio
us d
iseas
es a
nd th
eir
sequ
elae
, inc
ludi
ng th
ose
that
pro
tect
aga
inst
em
ergi
ng, r
e-em
ergi
ng, a
nd im
port
ant b
iode
fens
e-re
late
d pa
thog
ens.
1.2.
3 Ad
vanc
e th
e sc
ienc
e of
neo
nata
l and
mat
erna
l im
mun
ity
incl
udin
g im
mun
izat
ion
and
the
deve
lopm
ent o
f im
mun
olog
ical
mod
els t
o st
udy
mat
erna
l im
mun
izat
ion
and
effec
ts o
n off
sprin
g.1.
2.5
Dev
elop
new
app
roac
hes t
o va
ccin
e m
anuf
actu
ring
(e.g
., rap
id,
flexi
ble,
and
cos
t-eff
ectiv
e) to
mee
t dem
ands
for e
ffici
ent,
expa
ndab
le v
acci
ne p
rodu
ctio
n ca
paci
ty w
hile
also
mee
ting
need
s rel
ated
to o
ther
pub
lic h
ealth
em
erge
ncy
thre
ats s
uch
as
inte
rnat
iona
l em
ergi
ng d
iseas
es.
27U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
Obj
ectiv
e 1.
3:
Supp
ort r
esea
rch
on n
ovel
and
impr
oved
vac
cine
del
iver
y m
etho
ds.
1.3.
1 D
evel
op a
nd e
valu
ate
new
and
impr
oved
alte
rnat
e de
liver
y m
etho
ds o
f vac
cine
adm
inist
ratio
n to
opt
imiz
e th
e pr
otec
tive
imm
une
resp
onse
, saf
ety,
effec
tiven
ess,
and/
or e
ffici
ency
(e.g
., nu
mbe
r of d
oses
).1.
3.2
Expa
nd k
now
ledg
e re
gard
ing
the
indu
ctio
n an
d m
aint
enan
ce
of v
acci
ne im
mun
e re
spon
ses v
ia d
iffer
ent r
oute
s of
adm
inist
ratio
n (e
.g., m
ucos
al su
rface
s).
Obj
ectiv
e 1.
4: In
crea
se u
nder
stan
ding
of t
he h
ost i
mm
une
syst
em.
1.4.
1D
efine
the
capa
city
and
qua
lity
of in
nate
and
ada
ptiv
e hu
man
im
mun
e re
spon
se to
infe
ctio
ns a
mon
g di
vers
e ge
nder
, eth
nic,
ra
cial
, age
(chi
ldho
od, a
dole
scen
ce, a
nd a
dulth
ood)
, and
hea
lth
cond
ition
stat
us (e
.g., a
utoi
mm
une
com
prom
ised
indi
vidu
als)
po
pula
tions
in o
rder
to a
dvan
ce th
e un
ders
tand
ing
of im
mun
e pr
otec
tion.
1.4.
2 G
ain
a be
tter
und
erst
andi
ng o
f how
indu
ctio
n an
d re
call
of
imm
une
mem
ory
may
info
rm th
e de
velo
pmen
t of v
acci
nes
that
pro
vide
life
-long
pro
tect
ion.
1.4.
3 Su
ppor
t dev
elop
men
t of i
mm
unom
odul
ator
s inc
ludi
ng
vacc
ine
adju
vant
s tha
t fac
ilita
te th
e ap
prop
riate
cel
l-med
iate
d an
d an
tibod
y re
spon
ses f
or p
rote
ctio
n ag
ains
t pat
hoge
ns w
ith
dist
inct
effe
ctor
requ
irem
ents
.1.
4.4
Expa
nd k
now
ledg
e of
hos
t-re
late
d fa
ctor
s tha
t im
pact
seve
rity
of d
iseas
e an
d va
ccin
e-in
duce
d ho
st im
mun
e re
spon
se, a
nd
use
this
info
rmat
ion
to in
form
vac
cine
dev
elop
men
t.
28 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
1.4.
5D
evel
op a
dat
abas
e of
gen
e-ex
pres
sion
and
imm
unol
ogic
re
spon
ses t
o se
lect
ed c
urre
ntly
lice
nsed
vac
cine
s with
a fo
cus
on si
gnal
s tha
t cor
rela
te w
ith m
echa
nism
of a
ctio
n, p
rote
ctio
n,
safe
ty, a
nd a
dver
se e
vent
s. U
tiliz
e th
is co
mpe
ndiu
m to
info
rm
deve
lopm
ent o
f new
can
dida
te v
acci
nes a
nd a
djuv
ants
.1.
4.6
Stud
y m
ucos
al im
mun
ity fo
llow
ing
vacc
inat
ion
in o
rder
to
bett
er u
nder
stan
d va
ccin
e m
echa
nism
s and
to p
rovi
de n
ew,
pote
ntia
lly m
ore
rele
vant
, cor
rela
tes o
f pro
tect
ion
agai
nst
resp
irato
ry, e
nter
ic, g
enita
l, an
d ur
inar
y pa
thog
ens.
Obj
ectiv
e 1.
5:Su
ppor
t pro
duct
dev
elop
men
t, ev
alua
tion,
and
pro
duct
ion
tech
niqu
es
of v
acci
ne c
andi
date
s and
the
scie
ntifi
c to
ols n
eede
d fo
r the
ir ev
alua
tion.
1.5.
1 Su
ppor
t app
lied
rese
arch
to d
evel
op ra
pid
and
cost
-effi
cien
t pr
oduc
tion,
and
opt
imiz
e fo
rmul
atio
ns a
nd st
abili
ty p
rofil
es o
f cu
rrent
ly a
vaila
ble
vacc
ines
.1.
5.2
Supp
ort r
esea
rch
on a
nd d
evel
opm
ent o
f mor
e fle
xibl
e an
d ag
ile a
ppro
ache
s to
prod
uct d
evel
opm
ent,
man
ufac
turin
g pr
oduc
tion
tech
niqu
es in
clud
ing
mul
ti-us
e te
chno
logi
es su
ch
as p
latfo
rms,
and
qual
ity te
stin
g pr
oced
ures
(e.g
., pot
ency
and
sa
fety
test
ing)
.1.
5.3
Impr
ove
acce
ss to
pilo
t lot
man
ufac
turin
g fa
cilit
ies t
hat
prod
uce
clin
ical
gra
de m
ater
ial f
or e
valu
atin
g pr
omisi
ng
vacc
ine
cand
idat
es.
1.5.
4 Su
ppor
t tra
nsla
tiona
l res
earc
h th
at a
ccel
erat
es th
e de
velo
pmen
t of i
nfor
mat
ion
that
can
be
used
in th
e ev
alua
tion
and
licen
sure
pro
cess
.
29U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
1.5.
5 Es
tabl
ish a
nd st
reng
then
pub
lic a
nd p
rivat
e pa
rtne
rshi
ps to
ad
dres
s urg
ent n
eeds
in v
acci
ne re
sear
ch a
nd d
evel
opm
ent.
Obj
ectiv
e 1.
6:Im
prov
e th
e to
ols,
stan
dard
s, an
d ap
proa
ches
to a
sses
s the
safe
ty,
effica
cy, a
nd q
ualit
y of
vac
cine
s.1.
6.1
Impr
ove
assa
y de
velo
pmen
t for
cha
ract
eriz
atio
n of
nov
el c
ell
subs
trat
es.
1.6.
2 Im
prov
e eff
orts
to d
evel
op, r
efine
, and
val
idat
e ne
w b
iom
arke
rs
and
corre
late
s of i
mm
unity
.1.
6.3
Dev
elop
and
impr
ove
met
hods
to b
ette
r ass
ess v
acci
ne
effica
cy a
nd sa
fety
incl
udin
g as
sess
men
t of n
ew te
chno
logi
es
and
deve
lopm
ent o
f bet
ter a
nim
al m
odel
s.1.
6.4
Impr
ove
met
hods
for a
sses
sing
and
eval
uatin
g va
ccin
e qu
ality
, po
tenc
y, sa
fety
, and
effe
ctiv
enes
s.O
bjec
tive
2.1:
Ensu
re a
robu
st v
acci
ne sa
fety
scie
ntifi
c sy
stem
that
focu
ses o
n hi
gh
prio
rity
area
s.2.
1.1
Dev
elop
, prio
ritiz
e, a
nd re
gula
rly u
pdat
e a
natio
nal v
acci
ne
safe
ty sc
ient
ific
agen
da.
2.1.
2Re
tain
cur
rent
and
recr
uit a
dditi
onal
hig
hly
trai
ned
vacc
ine
safe
ty sc
ient
ists a
nd c
linic
ians
.2.
1.3
Impr
ove
labo
rato
ry, e
pide
mio
logi
cal,
and
stat
istic
al m
etho
ds
used
in V
acci
ne sa
fety
rese
arch
.O
bjec
tive
2.2:
Faci
litat
e th
e tim
ely
inte
grat
ion
of a
dvan
ces i
n m
anuf
actu
ring
scie
nces
an
d re
gula
tory
app
roac
hes r
elev
ant t
o m
anuf
actu
ring,
insp
ectio
n, a
nd
over
sight
to e
nhan
ce p
rodu
ct q
ualit
y an
d pa
tient
safe
ty.
30 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
2.2.
1Fa
cilit
ate
the
enha
ncem
ent o
f vac
cine
man
ufac
turin
g sc
ienc
es
and
qual
ity sy
stem
s, in
clud
ing
prod
uctio
n te
chno
logi
es,
in-p
roce
ss c
ontr
ols a
nd te
stin
g, a
nd id
entifi
catio
n of
bes
t pr
actic
es in
pre
vent
ive
qual
ity sy
stem
s and
ove
rsig
ht.
2.2.
2 D
evel
op, i
mpl
emen
t, an
d pe
riodi
cally
reas
sess
risk
-bas
ed
scie
ntifi
c ap
proa
ches
to id
entif
y in
spec
tiona
l prio
ritie
s and
bes
t pr
actic
es.
2.2.
3D
evel
op n
ew sc
ient
ific
met
hods
for b
oth
indu
stry
and
the
Food
and
Dru
g Ad
min
istra
tion
(FD
A) fo
r pro
duct
qua
lity
test
ing.
2.2.
4 As
sure
that
regu
latio
ns, g
uida
nce
docu
men
ts, p
olic
ies,
and
proc
edur
es th
at a
re re
leva
nt to
vac
cine
man
ufac
turin
g,
labo
rato
ry te
stin
g, a
nd q
ualit
y co
ntro
l inc
orpo
rate
the
mos
t cu
rrent
rele
vant
scie
ntifi
c in
form
atio
n to
pro
mot
e an
d en
hanc
e pr
oduc
t saf
ety.
31U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
C. E
nhan
ce ti
mel
y de
tect
ion
and
veri
ficat
ion
of v
acci
ne
safe
ty s
igna
ls a
nd d
evel
op a
va
ccin
e sa
fety
sci
entifi
c ag
enda
Goa
l 2:
Enha
nce
the
vacc
ine
safe
ty s
yste
m
Obj
ectiv
e 2.
1:En
sure
a ro
bust
vac
cine
safe
ty sc
ient
ific
syst
em th
at fo
cuse
s on
hig
h pr
iorit
y ar
eas.
2.1.
1
Dev
elop
, prio
ritiz
e, a
nd re
gula
rly u
pdat
e a
natio
nal v
acci
ne
safe
ty sc
ient
ific
agen
da.
2.1.
2
Reta
in c
urre
nt a
nd re
crui
t add
ition
al h
ighl
y tr
aine
d va
ccin
e sa
fety
scie
ntist
s and
clin
icia
ns.
2.1.
3Im
prov
e la
bora
tory
, epi
dem
iolo
gica
l, an
d st
atist
ical
met
hods
us
ed in
vac
cine
safe
ty re
sear
ch.
Obj
ectiv
e 2.
3:
Enha
nce
timel
y de
tect
ion
and
verifi
catio
n of
vac
cine
safe
ty si
gnal
s.2.
3.1
Im
prov
e th
e eff
ectiv
enes
s and
tim
elin
ess o
f sig
nal i
dent
ifica
tion
and
asse
ssm
ent t
hrou
gh c
oord
inat
ed u
se o
f pas
sive
and
activ
e su
rvei
llanc
e sy
stem
s, an
d fro
m p
rovi
ders
and
the
publ
ic.
2.3.
2
Impr
ove
the
proc
ess f
or a
sses
sing
adve
rse
even
t fol
low
ing
imm
uniz
atio
n (A
EFI)
signa
ls to
det
erm
ine
whi
ch si
gnal
s sho
uld
be e
valu
ated
furt
her i
n ep
idem
iolo
gica
l and
clin
ical
stud
ies.
32 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
Obj
ectiv
e 2.
4:
Impr
ove
timel
ines
s of t
he e
valu
atio
n of
vac
cine
safe
ty si
gnal
s, es
peci
ally
w
hen
1) a
hig
h-pr
iorit
y ne
w v
acci
ne sa
fety
con
cern
em
erge
s or 2
) whe
n a
new
vac
cine
is re
com
men
ded,
vac
cina
tion
reco
mm
enda
tions
are
ex
pand
ed, o
r dur
ing
publ
ic h
ealth
em
erge
ncie
s suc
h as
in a
n in
fluen
za
pand
emic
or o
ther
mas
s vac
cina
tion
cam
paig
n.2.
4.1
Expa
nd c
olla
bora
tion
with
clin
ical
, lab
orat
ory,
gene
tic,
stat
istic
al, a
nd b
ioin
form
atic
s exp
erts
to c
ondu
ct c
linic
al
rese
arch
stud
ies t
o in
vest
igat
e th
e ro
le o
f hos
t gen
etic
s in
AEFI
s.2.
4.2
Incr
ease
the
size,
repr
esen
tativ
enes
s, an
d ut
ility
of t
he
popu
latio
n un
der a
ctiv
e su
rvei
llanc
e fo
r ser
ious
AEF
Is th
at
can
be in
clud
ed in
tim
ely,
high
qua
lity,
rigor
ously
con
duct
ed
epid
emio
logi
cal s
tudi
es to
ass
ess v
acci
ne sa
fety
que
stio
ns.
Obj
ectiv
e 2.
5: Im
prov
e ca
usal
ity a
sses
smen
ts o
f vac
cine
s and
rela
ted
AEFI
s.2.
5.1
Build
upo
n ne
w sc
ient
ific
deve
lopm
ents
in a
reas
such
as
gene
tics,
syst
ems b
iolo
gy a
nd b
ioin
form
atic
s, an
d im
mun
olog
y to
dev
elop
and
val
idat
e to
ols w
hich
aid
in (o
r ena
ble)
the
iden
tifica
tion
of in
divi
dual
risk
fact
ors f
or A
EFIs
for w
hich
a
caus
al re
latio
nshi
p ha
s bee
n es
tabl
ished
.2.
5.2
Asse
ss th
e ev
iden
ce fo
r a c
ausa
l rel
atio
nshi
p be
twee
n ce
rtai
n va
ccin
es a
nd sp
ecifi
c cl
inic
ally
impo
rtan
t AEF
Is an
d, a
s the
ne
ed a
rises
, con
duct
an
inde
pend
ent r
evie
w o
f ava
ilabl
e ev
iden
ce.
Obj
ectiv
e 2.
6:
Impr
ove
scie
ntifi
c kn
owle
dge
abou
t why
and
am
ong
who
m v
acci
ne
adve
rse
reac
tions
occ
ur.
33U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
2.6.
1
Iden
tify
host
risk
fact
ors t
hat m
ay b
e as
soci
ated
with
incr
ease
d ris
k fo
r spe
cific
vac
cine
adv
erse
reac
tions
thro
ugh
basic
, clin
ical
, or
epi
dem
iolo
gica
l res
earc
h.2.
6.2
Id
entif
y th
e bi
olog
ical
mec
hani
sm(s
) for
vac
cine
adv
erse
re
actio
ns.
2.6.
3As
sess
whe
ther
the
risk
of sp
ecifi
c AE
FIs i
s inc
reas
ed in
spec
ific
popu
latio
ns su
ch a
s pre
gnan
t wom
en, p
rem
atur
e in
fant
s, ol
der
adul
ts, t
hose
with
imm
unoc
ompr
omisi
ng o
r oth
er m
edic
al
cond
ition
s, ba
sed
on g
ende
r or r
ace/
ethn
icity
, or o
ther
at-
risk
indi
vidu
als.
2.6.
4D
evel
op a
robu
st sy
stem
to e
nhan
ce c
olle
ctio
n of
med
ical
hi
stor
ies a
nd b
iolo
gica
l spe
cim
ens f
rom
sele
cted
per
sons
ex
perie
ncin
g se
rious
AEF
Is to
enh
ance
stud
y of
bio
logi
cal
mec
hani
sms a
nd in
divi
dual
risk
fact
ors.
Obj
ectiv
e 2.
8: E
nhan
ce c
olla
bora
tion
of v
acci
ne sa
fety
act
iviti
es.
2.8.
1
Impr
ove
colla
bora
tion,
such
as d
ata
shar
ing
arra
ngem
ents
, ac
ross
fede
ral a
genc
ies,
depa
rtm
ents
, and
with
non
-fede
ral
part
ners
.2.
8.2
Im
prov
e in
form
atio
n an
d da
ta sh
arin
g w
ith in
tern
atio
nal
part
ners
(e.g
., nat
iona
l vac
cine
safe
ty p
rogr
ams)
con
siste
nt w
ith
ethi
cal a
nd h
uman
subj
ects
pro
tect
ions
and
app
licab
le la
w,
incl
udin
g co
nfide
ntia
lity
prot
ectio
ns.
34 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
2.8.
3D
evel
op a
dditi
onal
stan
dard
cas
e de
finiti
ons f
or A
EFIs
for u
se
in im
mun
izat
ion
safe
ty su
rvei
llanc
e an
d re
sear
ch, v
acci
ne
safe
ty st
anda
rds s
uch
as c
once
pt d
efini
tions
, sta
ndar
dize
d ab
brev
iatio
ns, a
nd st
anda
rdiz
ed st
udy
desig
ns.
D. I
ncre
ase
awar
enes
s of
va
ccin
es, v
acci
ne-p
reve
ntab
le
dise
ases
, and
the
bene
fits/
risk
s of
imm
uniz
atio
n am
ong
the
publ
ic, p
rovi
ders
, and
oth
er
stak
ehol
ders
Goa
l 3:
Supp
ort i
nfor
med
vac
cine
dec
isio
n-m
akin
g
Obj
ectiv
e 3.
1:U
tiliz
e co
mm
unic
atio
n ap
proa
ches
that
are
bas
ed o
n on
goin
g re
sear
ch.
3.1.
1Co
nduc
t res
earc
h re
gula
rly to
und
erst
and
the
publ
ic’s
know
ledg
e, b
elie
fs, a
nd c
once
rns a
bout
vac
cine
s and
VPD
s.3.
1.2
Cond
uct r
esea
rch
on fa
ctor
s tha
t affe
ct d
ecisi
on-m
akin
g ab
out
vacc
inat
ion
for i
ndiv
idua
ls an
d fa
mili
es, p
rovi
ders
, and
pol
icy-
mak
ers.
3.1.
3Id
entif
y, de
velo
p, a
nd te
st e
duca
tiona
l str
ateg
ies t
hat b
ette
r en
able
pol
icy-
mak
ers t
o re
ad, u
nder
stan
d, a
nd u
se in
form
atio
n ab
out v
acci
ne b
enefi
ts a
nd ri
sks.
3.1.
4Ev
alua
te th
e eff
ectiv
enes
s of m
essa
ges a
nd m
ater
ials
in
addr
essin
g th
e in
form
atio
n ne
eds a
nd c
once
rns o
f the
pub
lic
and
unde
r-im
mun
ized
pop
ulat
ions
.
35U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
3.1.
5D
evel
op e
vide
nce-
base
d to
ols t
o as
sist i
ndiv
idua
ls, p
aren
ts,
and
prov
ider
s with
rele
vant
info
rmat
ion
to m
ake
info
rmed
de
cisio
ns re
gard
ing
vacc
inat
ion.
Obj
ectiv
e 3.
2:Bu
ild a
nd e
nhan
ce c
olla
bora
tions
and
par
tner
ship
s for
com
mun
icat
ion
effor
ts.
3.2.
1St
reng
then
exi
stin
g pa
rtne
rshi
ps a
nd c
oalit
ions
and
bu
ild re
latio
nshi
ps w
ith n
ew p
artn
ers t
o su
ppor
t rel
evan
t im
mun
izat
ions
acr
oss t
he li
fesp
an.
3.2.
2U
se c
ross
-age
ncy
and
intr
a-ag
ency
col
labo
ratio
n to
info
rm
deve
lopm
ent o
f com
mun
icat
ion
rese
arch
age
ndas
, pro
toco
ls,
cam
paig
ns a
nd m
essa
ges.
3.2.
3Co
llabo
rate
with
par
tner
s and
stak
ehol
ders
to c
omm
unic
ate
vacc
ine
bene
fits,
risks
, and
reco
mm
enda
tions
in a
cces
sible
fo
rmat
s and
in c
ultu
rally
app
ropr
iate
lang
uage
s, m
etho
ds, a
nd
liter
acy
leve
ls.3.
2.4
Util
ize
stat
e an
d lo
cal v
enue
s to
educ
ate
on v
acci
ne a
nd
imm
uniz
atio
n iss
ues t
o ex
pand
the
reac
h of
mes
sage
s out
side
of th
e tr
aditi
onal
clin
ical
sett
ing.
Obj
ectiv
e 3.
3:En
hanc
e de
liver
y of
tim
ely,
accu
rate
, and
tran
spar
ent i
nfor
mat
ion
to
publ
ic a
udie
nces
and
key
inte
rmed
iarie
s (su
ch a
s med
ia, p
rovi
ders
, and
pu
blic
hea
lth o
ffici
als)
abo
ut w
hat i
s kno
wn
and
unkn
own
abou
t the
be
nefit
s and
risk
s of v
acci
nes.
3.3.
1En
hanc
e co
mm
unic
atio
n of
new
find
ings
abo
ut v
acci
ne
effec
tiven
ess,
safe
ty, a
nd a
dmin
istra
tion
stud
ies t
o th
e pu
blic
, pa
rtne
rs a
nd p
rovi
ders
in a
cle
ar, t
rans
pare
nt a
nd ti
mel
y m
anne
r.
36 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
3.3.
2Re
spon
d in
a ra
pid,
coo
rdin
ated
, con
siste
nt, a
nd e
ffect
ive
man
ner t
o em
ergi
ng v
acci
ne is
sues
and
con
cern
s (e.
g., s
uppl
y, sa
fety
, or p
ublic
hea
lth e
mer
genc
ies)
.3.
3.3
Rapi
dly
and
effec
tivel
y di
ssem
inat
e co
mm
unic
atio
ns re
sear
ch
findi
ngs t
hrou
gh p
eer-r
evie
wed
jour
nals,
con
fere
nces
, med
ia,
and
part
ner c
omm
unic
atio
ns to
faci
litat
e im
plem
enta
tion
of
evid
ence
-bas
ed st
rate
gies
. O
bjec
tive
3.4:
Incr
ease
pub
lic a
war
enes
s of t
he b
enefi
ts a
nd ri
sks o
f vac
cine
s an
d im
mun
izat
ion,
esp
ecia
lly a
mon
g po
pula
tions
at r
isk o
f und
er-
imm
uniz
atio
n.3.
4.1
Dev
elop
, im
plem
ent,
and
eval
uate
a lo
ng-t
erm
stra
tegi
c co
mm
unic
atio
ns p
lan
and
prog
ram
aim
ed a
t edu
catin
g pa
rent
s, ca
regi
vers
of c
hild
ren,
ado
lesc
ents
, and
adu
lts
abou
t VPD
s; th
e be
nefit
s and
risk
s of v
acci
nes;
and
vacc
ine
reco
mm
enda
tions
.3.
4.2
Mai
ntai
n cu
rrent
, eas
ily a
cces
sible
, evi
denc
e-ba
sed
onlin
e in
form
atio
n on
VPD
s and
vac
cine
s, in
clud
ing
bene
fits a
nd
risks
and
the
basis
of i
mm
uniz
atio
n re
com
men
datio
ns, f
or a
ll au
dien
ce g
roup
s.3.
4.3
Eval
uate
new
med
ia (s
uch
as m
obile
tech
nolo
gies
and
soci
al
med
ia) a
nd u
tiliz
e it
appr
opria
tely
to re
ach
targ
et a
udie
nces
w
ith a
ccur
ate
and
timel
y in
form
atio
n ab
out v
acci
nes a
nd to
re
spon
d to
em
ergi
ng c
once
rns a
nd is
sues
.3.
4.4
Enha
nce
awar
enes
s of t
he im
port
ance
of i
mm
uniz
atio
n as
par
t of
pre
vent
ive
heal
th c
are
amon
g pa
rent
s, ad
oles
cent
s, an
d ad
ults
.
37U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
3.4.
5Co
llabo
rate
with
the
educ
atio
n co
mm
unity
to a
sses
s op
port
uniti
es to
inte
grat
e in
form
atio
n on
VPD
s, re
com
men
ded
vacc
ines
, pre
vent
ive
heal
th c
are,
and
pub
lic h
ealth
in e
xist
ing
educ
atio
nal c
urric
ula.
3.4.
6D
evel
op a
nd d
issem
inat
e va
ccin
e co
mm
unic
atio
n to
ols/
mat
eria
ls th
at a
re a
cces
sible
and
cul
tura
lly a
nd li
tera
cy-le
vel
appr
opria
te fo
r gro
ups a
t risk
of u
nder
-imm
uniz
atio
n.O
bjec
tive
3.5:
Ass
ure
that
key
dec
ision
- and
pol
icy-
mak
ers (
e.g.
, thi
rd-p
arty
pay
ers,
empl
oyer
s, le
gisla
tors
, com
mun
ity le
ader
s, ho
spita
l adm
inist
rato
rs,
heal
th d
epar
tmen
ts) r
ecei
ve a
ccur
ate
and
timel
y in
form
atio
n on
va
ccin
e be
nefit
s and
risk
s; ec
onom
ics;
and
publ
ic a
nd st
akeh
olde
r kn
owle
dge,
att
itude
s, an
d be
liefs
.3.
5.1
Dev
elop
, diss
emin
ate,
and
eva
luat
e br
oad-
base
d ed
ucat
ion
tool
s for
key
gro
ups o
n th
e va
lue,
risk
s, an
d co
st-e
ffect
iven
ess
of v
acci
nes;
the
basis
of i
mm
uniz
atio
n re
com
men
datio
ns;
busin
ess c
ase
evid
ence
and
gui
danc
e; v
acci
ne p
olic
y de
velo
pmen
t; th
e st
anda
rds o
f im
mun
izat
ion
prac
tice
and
adm
inist
ratio
n; a
nd v
acci
nes a
s a c
ompo
nent
of p
reve
ntiv
e he
alth
car
e.3.
5.2
Sele
ct a
nd im
plem
ent a
mod
el fo
r sus
tain
ed c
omm
unity
en
gage
men
t to
info
rm v
acci
ne p
olic
y an
d pr
ogra
m a
ctiv
ities
.3.
5.3
Prov
ide
vacc
ine
prog
ram
man
ager
s and
pol
icy-
mak
ers
info
rmat
ion
on th
e di
rect
and
indi
rect
cos
ts a
nd b
enefi
ts o
f va
ccin
atio
n. T
his i
nclu
des,
but i
s not
lim
ited
to, i
nfor
mat
ion
on
fede
ral a
nd st
ate
prog
ram
s tha
t offe
r low
-cos
t vac
cine
s.
38 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
3.5.
4Pr
ovid
e po
licy-
mak
ers w
ith d
ata
nece
ssar
y to
mak
e in
form
ed
deci
sions
on
the
utili
zatio
n of
vac
cine
s in
mas
s vac
cina
tion
prog
ram
s for
pub
lic h
ealth
em
erge
ncie
s.
E. U
se e
vide
nce-
base
d sc
ienc
e to
enh
ance
vac
cine
-pre
vent
able
di
seas
e su
rvei
llanc
e,
mea
sure
men
t of v
acci
ne
cove
rage
, and
mea
sure
men
t of
vacc
ine
effec
tiven
ess
Goa
l 1:
Dev
elop
new
and
impr
oved
vac
cine
sG
oal 2
: En
hanc
e th
e va
ccin
e sa
fety
sys
tem
Goa
l 4:
Ensu
re a
sta
ble
supp
ly o
f, ac
cess
to, a
nd b
ette
r use
of r
ecom
men
ded
vacc
ines
in th
e U
.S.
Obj
ectiv
e 1.
1:Pr
iorit
ize
new
vac
cine
targ
ets o
f dom
estic
and
glo
bal p
ublic
hea
lth
impo
rtan
ce.
1.1.
2Co
nduc
t and
impr
ove
dise
ase
surv
eilla
nce
of e
xist
ing
path
ogen
s and
opt
imiz
e m
etho
ds to
det
ect n
ew p
atho
gens
to
cont
inuo
usly
info
rm th
e pr
iorit
ies f
or p
oten
tial n
ew v
acci
nes.
Obj
ectiv
e 1.
2:Su
ppor
t res
earc
h to
dev
elop
and
man
ufac
ture
new
vac
cine
can
dida
tes
and
impr
ove
curre
nt v
acci
nes t
o pr
even
t inf
ectio
us d
iseas
es.
1.2.
1 Co
nduc
t and
supp
ort e
xpan
ded
vacc
ine
rese
arch
to m
eet
med
ical
and
pub
lic h
ealth
nee
ds. E
stab
lish
surv
eilla
nce
syst
ems
or st
udie
s to
bett
er a
sses
s dise
ase
burd
en in
spec
ific
targ
et
popu
latio
ns in
clud
ing
neon
ates
, inf
ants
, chi
ldre
n, o
lder
adu
lts,
preg
nant
wom
en, i
mm
unoc
ompr
omise
d in
divi
dual
s, an
d ot
her
at-r
isk in
divi
dual
s.
39U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
Obj
ectiv
e 1.
6:Im
prov
e th
e to
ols,
stan
dard
s, an
d ap
proa
ches
to a
sses
s the
safe
ty,
effica
cy, a
nd q
ualit
y of
vac
cine
s.1.
6.1
Impr
ove
assa
y de
velo
pmen
t for
cha
ract
eriz
atio
n of
nov
el c
ell
subs
trat
es.
1.6.
2 Im
prov
e eff
orts
to d
evel
op, r
efine
, and
val
idat
e ne
w b
iom
arke
rs
and
corre
late
s of i
mm
unity
.1.
6.3
Dev
elop
and
impr
ove
met
hods
to b
ette
r ass
ess v
acci
ne
effica
cy a
nd sa
fety
incl
udin
g as
sess
men
t of n
ew te
chno
logi
es
and
deve
lopm
ent o
f bet
ter a
nim
al m
odel
s.1.
6.4
Impr
ove
met
hods
for a
sses
sing
and
eval
uatin
g va
ccin
e qu
ality
, po
tenc
y, sa
fety
, and
effe
ctiv
enes
s.O
bjec
tive
2.8:
Enha
nce
colla
bora
tion
of v
acci
ne sa
fety
act
iviti
es.
2.8.
1
Impr
ove
colla
bora
tion,
such
as d
ata
shar
ing
arra
ngem
ents
, ac
ross
fede
ral a
genc
ies,
depa
rtm
ents
, and
with
non
-fede
ral
part
ners
.2.
8.2
.
Impr
ove
info
rmat
ion
and
data
shar
ing
with
inte
rnat
iona
l pa
rtne
rs (e
.g., n
atio
nal v
acci
ne sa
fety
pro
gram
s) c
onsis
tent
with
et
hica
l and
hum
an su
bjec
ts p
rote
ctio
ns a
nd a
pplic
able
law
, in
clud
ing
confi
dent
ialit
y pr
otec
tions
2.8.
3D
evel
op a
dditi
onal
stan
dard
cas
e de
finiti
ons f
or A
EFIs
for u
se
in im
mun
izat
ion
safe
ty su
rvei
llanc
e an
d re
sear
ch, v
acci
ne
safe
ty st
anda
rds s
uch
as c
once
pt d
efini
tions
, sta
ndar
dize
d ab
brev
iatio
ns, a
nd st
anda
rdiz
ed st
udy
desig
ns.
Obj
ectiv
e 4.
2:
Ensu
re c
onsis
tent
and
stab
le d
eliv
ery
of v
acci
nes f
or th
e U
.S.
40 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
4.2.
7Im
plem
ent,
mon
itor,
and
eval
uate
evi
denc
e-ba
sed
inte
rven
tions
des
igne
d to
raise
and
sust
ain
high
vac
cina
tion
cove
rage
acr
oss t
he li
fesp
an.
4.2.
8M
onito
r and
eva
luat
e th
e im
pact
of s
tate
imm
uniz
atio
n la
ws
and
regu
latio
ns o
n va
ccin
e co
vera
ge, i
nclu
ding
chi
ldca
re,
pre-
scho
ol, s
choo
l, co
llege
pre
mat
ricul
atio
n re
quire
men
ts,
empl
oyer
requ
irem
ents
, and
the
role
of e
xem
ptio
ns,
insu
ranc
e m
anda
tes,
and
imm
uniz
atio
n in
form
atio
n sy
stem
s re
quire
men
ts.
Obj
ectiv
e 4.
4:M
aint
ain
and
enha
nce
the
capa
city
to m
onito
r im
mun
izat
ion
cove
rage
fo
r vac
cine
s rou
tinel
y ad
min
ister
ed to
all
age
grou
ps.
4.4.
1Id
entif
y, im
plem
ent,
and
eval
uate
cos
t-eff
ectiv
e an
d ra
pid
met
hods
, suc
h as
the
use
of II
S or
inte
rnet
pan
el su
rvey
s, fo
r ass
essin
g va
ccin
atio
n co
vera
ge b
y ca
tego
ries,
incl
udin
g ag
e gr
oups
, gro
ups a
t risk
of u
nder
imm
uniz
atio
n, b
y ty
pe o
f va
ccin
e, a
nd ty
pe o
f fina
ncin
g.4.
4.2
Impr
ove
the
com
plet
enes
s of,
use
of, a
nd c
omm
unic
atio
n be
twee
n, II
S an
d EH
R to
mon
itor v
acci
natio
n co
vera
ge.
4.4.
3Su
ppor
t the
ado
ptio
n of
nat
iona
l cer
tified
, int
erop
erab
le h
ealth
in
form
atio
n te
chno
logy
and
EH
R fo
r im
mun
izat
ion.
4.4.
4Su
ppor
t and
impr
ove
exist
ing
surv
eys a
sses
sing
imm
uniz
atio
n co
vera
ge (e
.g., t
he N
atio
nal I
mm
uniz
atio
n Su
rvey
and
the
Beha
vior
al R
isk F
acto
r Sur
veill
ance
Sys
tem
), to
incl
ude
mor
e re
pres
enta
tive
sam
ples
and
tim
ely
repo
rtin
g of
dat
a.
41U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
Obj
ectiv
e 4.
5:En
hanc
e tr
acki
ng o
f VPD
s and
mon
itorin
g of
the
effec
tiven
ess o
f lic
ense
d va
ccin
es.
4.5.
1St
reng
then
epi
dem
iolo
gic
and
labo
rato
ry m
etho
ds a
nd
tool
s to
diag
nose
VPD
s, as
sess
pop
ulat
ion
susc
eptib
ility
, an
d ch
arac
teriz
e va
ccin
e eff
ectiv
enes
s and
the
impa
ct o
f va
ccin
atio
n co
vera
ge o
n cl
inic
al a
nd p
ublic
hea
lth o
utco
mes
.4.
5.2
Mon
itor c
ircul
atin
g st
rain
s of r
elev
ant v
acci
ne-p
reve
ntab
le
and
pote
ntia
lly v
acci
ne-p
reve
ntab
le p
atho
gens
, inc
ludi
ng
emer
ging
and
re-e
mer
ging
dise
ases
.4.
5.3
Impr
ove
mon
itorin
g of
dise
ase
burd
en a
nd d
eter
min
e ep
idem
iolo
gic
and
clin
ical
cha
ract
erist
ics o
f cas
es o
f VPD
s and
po
tent
ial V
PDs b
y su
ppor
ting
trad
ition
al su
rvei
llanc
e an
d us
e of
hea
lth in
form
atio
n te
chno
logy
, int
erop
erab
le d
ata
stan
dard
s, an
d ne
w d
ata
reso
urce
s.4.
5.4
Dev
elop
and
mai
ntai
n ca
paci
ty to
rapi
dly
estim
ate
the
effec
tiven
ess o
f new
vac
cine
s, su
ch a
s pan
dem
ic a
nd p
re-
pand
emic
influ
enza
vac
cine
s.4.
5.5
Assu
re ra
pid
and
com
preh
ensiv
e id
entifi
catio
n, in
vest
igat
ion,
an
d re
spon
se to
vac
cine
- pre
vent
able
dise
ase
outb
reak
s.4.
5.6
Assu
re ti
mel
y ev
alua
tion
to a
sses
s vac
cine
effe
ctiv
enes
s, du
ratio
n of
pro
tect
ion,
and
indi
rect
(com
mun
ity a
nd h
erd)
pr
otec
tion
by c
urre
nt a
nd n
ewly
reco
mm
ende
d va
ccin
es.
42 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
Obj
ectiv
e 4.
9: E
nhan
ce im
mun
izat
ion
cove
rage
for t
rave
lers
.4.
9.1
Defi
ne th
e po
pula
tions
at r
isk fo
r acq
uirin
g in
tern
atio
nal
trav
el-re
late
d VP
Ds,
and
iden
tify
and
addr
ess b
arrie
rs to
thei
r re
ceiv
ing
imm
uniz
atio
ns.
4.9.
2As
sess
ove
rall
imm
uniz
atio
n st
atus
dur
ing
trav
el-re
late
d im
mun
izat
ion
clin
ics.
F. E
limin
ate
finan
cial
bar
rier
s fo
r pro
vide
rs a
nd c
onsu
mer
s to
faci
litat
e ac
cess
to ro
utin
ely
reco
mm
ende
d va
ccin
es
Goa
l 4:
Ensu
re a
sta
ble
supp
ly o
f, ac
cess
to, a
nd b
ette
r use
of r
ecom
men
ded
vacc
ines
in th
e U
.S.
Obj
ectiv
e 4.
3:Re
duce
fina
ncia
l bar
riers
to v
acci
natio
n.4.
3.1
Iden
tify
and
regu
larly
mon
itor fi
nanc
ial b
arrie
rs to
rece
ipt
of A
dviso
ry C
omm
ittee
for I
mm
uniz
atio
n Pr
actic
es (A
CIP)
-re
com
men
ded
and
CDC-
adop
ted
vacc
ines
.4.
3.3
Stre
ngth
en th
e ab
ility
of s
tate
s to
purc
hase
, and
exp
and
acce
ss
to, A
CIP-
reco
mm
ende
d an
d CD
C-ad
opte
d va
ccin
es fo
r tho
se
who
qua
lify
for p
ublic
ly su
ppor
ted
vacc
inat
ions
.4.
3.4
Dev
elop
, im
plem
ent,
and
eval
uate
stra
tegi
es to
redu
ce th
e fin
anci
al b
urde
n on
vac
cina
tion
prov
ider
s for
pur
chas
e of
initi
al
and
ongo
ing
vacc
ine
inve
ntor
ies.
Obj
ectiv
e 4.
6:Ed
ucat
e an
d su
ppor
t hea
lth c
are
prov
ider
s in
vacc
inat
ion
coun
selin
g an
d va
ccin
e de
liver
y fo
r the
ir pa
tient
s and
them
selv
es.
43U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
4.6.
4Pr
omot
e an
d su
ppor
t edu
catio
nal a
nd te
chni
cal a
ssist
ance
to
impr
ove
busin
ess p
ract
ices
ass
ocia
ted
with
pro
vidi
ng
imm
uniz
atio
ns, s
uch
as e
duca
ting
prov
ider
s and
enr
ollin
g ne
w
prov
ider
s int
o th
e Va
ccin
es fo
r Chi
ldre
n pr
ogra
m, i
nclu
ding
no
n-tr
aditi
onal
pro
vide
rs.
4.6.
6Su
ppor
t ade
quat
e re
imbu
rsem
ent f
or v
acci
ne c
ouns
elin
g,
adm
inist
ratio
n, st
orag
e an
d ha
ndlin
g by
pro
vide
rs u
nder
pub
lic
sect
or a
nd p
rivat
e he
alth
pla
ns.
4.6.
7Su
ppor
t res
earc
h to
eva
luat
e th
e ca
paci
ty (a
ccom
mod
atin
g th
e in
crea
sed
num
ber o
f pat
ient
visi
ts re
quire
d to
rece
ive
reco
mm
ende
d va
ccin
es) o
f hea
lth c
are
prov
ider
s to
impl
emen
t va
ccin
e re
com
men
datio
ns fo
r all
age
grou
ps.
Obj
ectiv
e 4.
8:St
reng
then
the
Nat
iona
l Vac
cine
Inju
ry C
ompe
nsat
ion
Prog
ram
(VIC
P)
and
Coun
term
easu
res I
njur
y Co
mpe
nsat
ion
Prog
ram
(CIC
P).
4.8.
3Co
ntin
ue to
ens
ure
fair
and
effici
ent c
ompe
nsat
ion
for v
acci
ne-
rela
ted
inju
ries.
4.8.
4Ex
amin
e al
tern
ativ
e ap
proa
ches
, and
eva
luat
e an
d im
plem
ent
thos
e de
emed
opt
imal
, for
adj
udic
atio
n of
VIC
P cl
aim
s for
ill
ness
es n
ot in
clud
ed in
the
Vacc
ine
Inju
ry Ta
ble
to th
e ex
tent
pe
rmitt
ed b
y ap
plic
able
law
.
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
G. C
reat
e an
ade
quat
e an
d st
able
vac
cine
sup
ply
rout
inel
y re
com
men
ded
vacc
ines
and
va
ccin
es fo
r pub
lic h
ealth
pr
epar
edne
ss
Goa
l 1:
Dev
elop
new
and
impr
oved
vac
cine
sG
oal 4
: En
sure
a s
tabl
e su
pply
of,
acce
ss to
, and
bet
ter u
se o
f rec
omm
ende
d va
ccin
es in
the
U.S
.
Obj
ectiv
e 1.
2:Su
ppor
t res
earc
h to
dev
elop
and
man
ufac
ture
new
vac
cine
can
dida
tes
and
impr
ove
curre
nt v
acci
nes t
o pr
even
t inf
ectio
us d
iseas
es.
1.2.
5D
evel
op n
ew a
ppro
ache
s to
vacc
ine
man
ufac
turin
g (e
.g., r
apid
, fle
xibl
e, a
nd c
ost-
effec
tive)
to m
eet d
eman
ds fo
r effi
cien
t, ex
pand
able
vac
cine
pro
duct
ion
capa
city
whi
le a
lso m
eetin
g ne
eds r
elat
ed to
oth
er p
ublic
hea
lth e
mer
genc
y th
reat
s suc
h as
in
tern
atio
nal e
mer
ging
dise
ases
.O
bjec
tive
1.5:
Supp
ort p
rodu
ct d
evel
opm
ent,
eval
uatio
n, a
nd p
rodu
ctio
n te
chni
ques
of
vac
cine
can
dida
tes a
nd th
e sc
ient
ific
tool
s nee
ded
for t
heir
eval
uatio
n.1.
5.1
Supp
ort a
pplie
d re
sear
ch to
dev
elop
rapi
d an
d co
st-e
ffici
ent
prod
uctio
n, a
nd o
ptim
ize
form
ulat
ions
and
stab
ility
pro
files
of
curre
ntly
ava
ilabl
e va
ccin
es.
1.5
.2
Supp
ort r
esea
rch
on a
nd d
evel
opm
ent o
f mor
e fle
xibl
e an
d ag
ile a
ppro
ache
s to
prod
uct d
evel
opm
ent,
man
ufac
turin
g pr
oduc
tion
tech
niqu
es in
clud
ing
mul
ti-us
e te
chno
logi
es su
ch
as p
latfo
rms,
and
qual
ity te
stin
g pr
oced
ures
(e.g
., pot
ency
and
sa
fety
test
ing)
.
45U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
1.5.
3 Im
prov
e ac
cess
to p
ilot l
ot m
anuf
actu
ring
faci
litie
s tha
t pr
oduc
e cl
inic
al g
rade
mat
eria
l for
eva
luat
ing
prom
ising
va
ccin
e ca
ndid
ates
.1.
5.4
Supp
ort t
rans
latio
nal r
esea
rch
that
acc
eler
ates
the
deve
lopm
ent o
f inf
orm
atio
n th
at c
an b
e us
ed in
the
eval
uatio
n an
d lic
ensu
re p
roce
ss.
1.5.
5 Es
tabl
ish a
nd st
reng
then
pub
lic a
nd p
rivat
e pa
rtne
rshi
ps to
ad
dres
s urg
ent n
eeds
in v
acci
ne re
sear
ch a
nd d
evel
opm
ent.
Obj
ectiv
e 4.
1:En
sure
con
siste
nt a
nd a
dequ
ate
supp
ly o
f vac
cine
s for
the
U.S
.4.
1.1
Det
erm
ine
barr
iers
to h
avin
g m
ultip
le su
pplie
rs fo
r eac
h va
ccin
e lic
ense
d an
d re
com
men
ded
for r
outin
e us
e in
the
U.S
.4.
1.2
Prom
ote
harm
oniz
atio
n of
inte
rnat
iona
l vac
cine
regu
lato
ry
stan
dard
s for
lice
nsur
e.4.
1.3
Impr
ove
vacc
ine
qual
ity a
nd a
vaila
bilit
y th
roug
h be
tter
m
anuf
actu
ring
and
prod
uctio
n ov
ersig
ht.
4.1.
4O
ptim
ize
use,
con
tent
, and
dist
ribut
ion
of v
acci
ne st
ockp
iles
and
anci
llary
supp
lies.
4.1.
5Im
prov
e th
e de
velo
pmen
t of,
com
mun
icat
ion
of, a
nd tr
acki
ng
of a
dher
ence
to re
com
men
ded
chan
ges i
n va
ccin
e us
e du
ring
natio
nal v
acci
ne sh
orta
ges.
Obj
ectiv
e 4.
5:En
hanc
e tr
acki
ng o
f VPD
s and
mon
itorin
g of
the
effec
tiven
ess o
f lic
ense
d va
ccin
es.
46 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
4.5.
1St
reng
then
epi
dem
iolo
gic
and
labo
rato
ry m
etho
ds a
nd
tool
s to
diag
nose
VPD
s, as
sess
pop
ulat
ion
susc
eptib
ility
, an
d ch
arac
teriz
e va
ccin
e eff
ectiv
enes
s and
the
impa
ct o
f va
ccin
atio
n co
vera
ge o
n cl
inic
al a
nd p
ublic
hea
lth o
utco
mes
.4.
5.2
Mon
itor c
ircul
atin
g st
rain
s of r
elev
ant v
acci
ne-p
reve
ntab
le
and
pote
ntia
lly v
acci
ne-p
reve
ntab
le p
atho
gens
, inc
ludi
ng
emer
ging
and
re-e
mer
ging
dise
ases
.4.
5.3
Impr
ove
mon
itorin
g of
dise
ase
burd
en a
nd d
eter
min
e ep
idem
iolo
gic
and
clin
ical
cha
ract
erist
ics o
f cas
es o
f VPD
s and
po
tent
ial V
PDs b
y su
ppor
ting
trad
ition
al su
rvei
llanc
e an
d us
e of
hea
lth in
form
atio
n te
chno
logy
, int
erop
erab
le d
ata
stan
dard
s, an
d ne
w d
ata
reso
urce
s.4.
5.4
Dev
elop
and
mai
ntai
n ca
paci
ty to
rapi
dly
estim
ate
the
effec
tiven
ess o
f new
vac
cine
s, su
ch a
s pan
dem
ic a
nd p
re-
pand
emic
influ
enza
vac
cine
s.4.
5.5
Assu
re ra
pid
and
com
preh
ensiv
e id
entifi
catio
n, in
vest
igat
ion,
an
d re
spon
se to
vac
cine
- pre
vent
able
dise
ase
outb
reak
s.
4.5.
6As
sure
tim
ely
eval
uatio
n to
ass
ess v
acci
ne e
ffect
iven
ess,
dura
tion
of p
rote
ctio
n, a
nd in
dire
ct (c
omm
unity
and
her
d)
prot
ectio
n by
cur
rent
and
new
ly re
com
men
ded
vacc
ines
.
47U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
H. I
ncre
ase
the
use
of
inte
rope
rabl
e he
alth
in
form
atio
n an
d el
ectr
onic
he
alth
reco
rds
Goa
l 4:
Ensu
re a
sta
ble
supp
ly o
f, ac
cess
to, a
nd b
ette
r use
of r
ecom
men
ded
vacc
ines
in th
e U
.S.
Obj
ectiv
e 4.
4:M
aint
ain
and
enha
nce
the
capa
city
to m
onito
r im
mun
izat
ion
cove
rage
fo
r vac
cine
s rou
tinel
y ad
min
ister
ed to
all
age
grou
ps.
4.4.
1Id
entif
y, im
plem
ent,
and
eval
uate
cos
t-eff
ectiv
e an
d ra
pid
met
hods
, suc
h as
the
use
of II
S or
inte
rnet
pan
el su
rvey
s, fo
r ass
essin
g va
ccin
atio
n co
vera
ge b
y ca
tego
ries,
incl
udin
g ag
e gr
oups
, gro
ups a
t risk
of u
nder
imm
uniz
atio
n, b
y ty
pe o
f va
ccin
e, a
nd ty
pe o
f fina
ncin
g.4.
4.2
Impr
ove
the
com
plet
enes
s of,
use
of, a
nd c
omm
unic
atio
n be
twee
n, II
S an
d EH
R to
mon
itor v
acci
natio
n co
vera
ge.
4.4.
3Su
ppor
t the
ado
ptio
n of
nat
iona
l cer
tified
, int
erop
erab
le h
ealth
in
form
atio
n te
chno
logy
and
EH
R fo
r im
mun
izat
ion.
4.4.
4Su
ppor
t and
impr
ove
exist
ing
surv
eys a
sses
sing
imm
uniz
atio
n co
vera
ge (e
.g., t
he N
atio
nal I
mm
uniz
atio
n Su
rvey
and
the
Beha
vior
al R
isk F
acto
r Sur
veill
ance
Sys
tem
), to
incl
ude
mor
e re
pres
enta
tive
sam
ples
and
tim
ely
repo
rtin
g of
dat
a.O
bjec
tive
4.6:
Educ
ate
and
supp
ort h
ealth
car
e pr
ovid
ers i
n va
ccin
atio
n co
unse
ling
and
vacc
ine
deliv
ery
for t
heir
patie
nts a
nd th
emse
lves
.
48 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
4.6.
2Ex
pand
and
impl
emen
t tra
inin
g an
d ed
ucat
ion
of
imm
uniz
atio
n pr
ovid
ers a
t all
leve
ls of
thei
r edu
catio
n on
th
e pr
oper
use
and
adm
inist
ratio
n of
vac
cine
s; th
e pr
oper
st
orag
e an
d ha
ndlin
g of
vac
cine
s; th
e ba
sis o
f im
mun
izat
ion
reco
mm
enda
tions
; the
safe
ty o
f vac
cine
s; re
port
ing
of A
EFIs;
un
ders
tand
ing
of th
e va
ccin
e sa
fety
syst
em; a
nd o
n th
e st
anda
rds o
f im
mun
izat
ion
prac
tice
(e.g
., vac
cine
edu
catio
n m
odul
es in
prim
ary
care
and
con
tinui
ng m
edic
al e
duca
tion
prog
ram
s).
4.6.
5Ex
pand
the
inco
rpor
atio
n of
vac
cina
tions
and
the
use
of II
S in
to q
ualit
y im
prov
emen
t pro
gram
s suc
h as
the
Hea
lthca
re
Effec
tiven
ess D
ata
and
Info
rmat
ion
Set.
49U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
I. Im
prov
e gl
obal
sur
veill
ance
fo
r vac
cine
-pre
vent
able
di
seas
es a
nd s
tren
gthe
n gl
obal
he
alth
info
rmat
ion
syst
ems
to m
onito
r vac
cine
cov
erag
e,
effec
tiven
ess,
and
saf
ety
Goa
l 4:
Ensu
re a
sta
ble
supp
ly o
f, ac
cess
to, a
nd b
ette
r use
of r
ecom
men
ded
vacc
ines
in th
e U
.S.
Goa
l 5:
Incr
ease
glo
bal p
reve
ntio
n of
dea
th a
nd d
isea
se th
roug
h sa
fe a
nd e
ffect
ive
vacc
inat
ion
Obj
ectiv
e 4.
5:En
hanc
e tr
acki
ng o
f VPD
s and
mon
itorin
g of
the
effec
tiven
ess o
f lic
ense
d va
ccin
es.
4.5.
1St
reng
then
epi
dem
iolo
gic
and
labo
rato
ry m
etho
ds a
nd
tool
s to
diag
nose
VPD
s, as
sess
pop
ulat
ion
susc
eptib
ility
, an
d ch
arac
teriz
e va
ccin
e eff
ectiv
enes
s and
the
impa
ct o
f va
ccin
atio
n co
vera
ge o
n cl
inic
al a
nd p
ublic
hea
lth o
utco
mes
.4.
5.2
Mon
itor c
ircul
atin
g st
rain
s of r
elev
ant v
acci
ne-p
reve
ntab
le
and
pote
ntia
lly v
acci
ne-p
reve
ntab
le p
atho
gens
, inc
ludi
ng
emer
ging
and
re-e
mer
ging
dise
ases
.4.
5.3
Impr
ove
mon
itorin
g of
dise
ase
burd
en a
nd d
eter
min
e ep
idem
iolo
gic
and
clin
ical
cha
ract
erist
ics o
f cas
es o
f VPD
s and
po
tent
ial V
PDs b
y su
ppor
ting
trad
ition
al su
rvei
llanc
e an
d us
e of
hea
lth in
form
atio
n te
chno
logy
, int
erop
erab
le d
ata
stan
dard
s, an
d ne
w d
ata
reso
urce
s.4.
5.4
Dev
elop
and
mai
ntai
n ca
paci
ty to
rapi
dly
estim
ate
the
effec
tiven
ess o
f new
vac
cine
s, su
ch a
s pan
dem
ic a
nd p
re-
pand
emic
influ
enza
vac
cine
s.
50 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
4.5.
5As
sure
rapi
d an
d co
mpr
ehen
sive
iden
tifica
tion,
inve
stig
atio
n,
and
resp
onse
to v
acci
ne- p
reve
ntab
le d
iseas
e ou
tbre
aks.
4.5.
6As
sure
tim
ely
eval
uatio
n to
ass
ess v
acci
ne e
ffect
iven
ess,
dura
tion
of p
rote
ctio
n, a
nd in
dire
ct (c
omm
unity
and
her
d)
prot
ectio
n by
cur
rent
and
new
ly re
com
men
ded
vacc
ines
.O
bjec
tive
5.1:
Supp
ort i
nter
natio
nal o
rgan
izat
ions
and
cou
ntrie
s to
impr
ove
glob
al
surv
eilla
nce
for V
PDs a
nd st
reng
then
hea
lth in
form
atio
n sy
stem
s to
mon
itor v
acci
ne c
over
age,
effe
ctiv
enes
s, an
d sa
fety
.5.
1.1
Achi
eve
sust
aina
ble
WH
O c
ertifi
catio
n qu
ality
surv
eilla
nce
for
erad
icat
ion
of ta
rget
ed V
PDs.
5.1.
2Ex
pand
and
impr
ove
sust
aina
ble
surv
eilla
nce
syst
ems f
or a
ll di
seas
es h
avin
g W
HO
-reco
mm
ende
d va
ccin
es a
nd d
iseas
es fo
r w
hich
vac
cine
intr
oduc
tion
is be
ing
cons
ider
ed.
5.1.
3St
reng
then
all
leve
ls of
glo
bal l
abor
ator
y ne
twor
ks (i
nclu
ding
na
tiona
l, re
gion
al, a
nd g
loba
l ref
eren
ce la
bora
torie
s) to
sust
ain
and
impr
ove
VPD
dia
gnos
is in
ord
er to
est
ablis
h ba
selin
e di
seas
e bu
rden
, det
ect o
utbr
eaks
, det
ect n
ewly
em
ergi
ng
varia
nts o
f VPD
s, an
d m
onito
r the
impa
ct o
f new
vac
cine
s. T
his
labo
rato
ry c
apac
ity sh
ould
also
be
deve
lope
d fo
r sur
veill
ance
of
pot
entia
l pub
lic h
ealth
em
erge
ncie
s of i
nter
natio
nal
conc
ern.
5.1.
4En
hanc
e as
sess
men
ts o
f em
ergi
ng v
aria
nts o
r str
ains
of V
PD
agen
ts.
5.1.
5D
evel
op n
ew d
iagn
ostic
test
s, to
ols a
nd p
roce
dure
s to
impr
ove
both
fiel
d-ba
sed
and
labo
rato
ry c
onfir
mat
ion
of d
iagn
oses
.
51U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
Obj
ectiv
e 5.
2:Su
ppor
t int
erna
tiona
l org
aniz
atio
ns a
nd c
ount
ries t
o im
prov
e an
d su
stai
n im
mun
izat
ion
prog
ram
s as a
com
pone
nt o
f hea
lth c
are
deliv
ery
syst
ems a
nd p
rom
ote
oppo
rtun
ities
to li
nk im
mun
izat
ion
deliv
ery
with
ot
her p
riorit
y he
alth
inte
rven
tions
, whe
re a
ppro
pria
te.
5.2.
1Pr
ovid
e te
chni
cal s
uppo
rt to
cou
ntrie
s, m
ultil
ater
al in
stitu
tions
, an
d ot
her p
artn
ers t
o st
reng
then
key
com
pone
nts o
f im
mun
izat
ion
prog
ram
man
agem
ent a
nd im
plem
enta
tion,
in
clud
ing
epid
emio
logi
cal a
naly
sis, c
ompr
ehen
sive
plan
ning
, va
ccin
e di
strib
utio
n an
d sa
fe a
dmin
istra
tion,
mon
itorin
g,
info
rmat
ion
syst
ems,
and
prog
ram
eva
luat
ion.
Obj
ectiv
e 5.
6:
Build
and
stre
ngth
en m
ultil
ater
al a
nd b
ilate
ral p
artn
ersh
ips a
nd o
ther
co
llabo
rativ
e eff
orts
to su
ppor
t glo
bal i
mm
uniz
atio
n an
d er
adic
atio
n pr
ogra
ms.
5.6.
1Pa
rtic
ipat
e in
est
ablis
hing
glo
bal i
mm
uniz
atio
n pr
iorit
ies,
goal
s an
d ob
ject
ives
and
pro
vide
tech
nica
l ass
istan
ce a
t glo
bal,
regi
onal
, and
nat
iona
l lev
els.
5.6.
3Co
ntrib
ute
to d
evel
opm
ent a
nd im
plem
enta
tion
of a
pla
n es
tabl
ishin
g th
e sc
ient
ific
basis
for V
PD e
radi
catio
n/el
imin
atio
n,
iden
tifyi
ng o
ptim
al v
acci
natio
n ap
proa
ches
, and
dev
elop
ing
stra
tegi
es to
min
imiz
e ris
ks in
the
post
-era
dica
tion
perio
d.
5.6.
4Pa
rtic
ipat
e in
regi
onal
imm
uniz
atio
n in
itiat
ives
, suc
h as
thos
e ad
opte
d by
the
Pan
Amer
ican
Hea
lth O
rgan
izat
ion
and
othe
r W
HO
regi
ons.
52 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
J. S
uppo
rt g
loba
l int
rodu
ctio
n an
d av
aila
bilit
y of
new
and
un
der-
utili
zed
vacc
ines
to
prev
ent d
isea
ses
of p
ublic
he
alth
impo
rtan
ce
Goa
l 1:
Dev
elop
new
and
impr
oved
vac
cine
sG
oal 5
: In
crea
se g
loba
l pre
vent
ion
of d
eath
and
dis
ease
thro
ugh
safe
and
effe
ctiv
e va
ccin
atio
n
Obj
ectiv
e 1.
1:Pr
iorit
ize
new
vac
cine
targ
ets o
f dom
estic
and
glo
bal p
ublic
hea
lth
impo
rtan
ce.
1.1.
1D
evel
op a
nd im
plem
ent a
pro
cess
for p
riorit
izin
g an
d ev
alua
ting
new
Vac
cine
targ
ets o
f dom
estic
and
glo
bal p
ublic
he
alth
impo
rtan
ce. T
his c
atal
ogue
of v
acci
ne ta
rget
s (in
clud
ing
impr
oved
vac
cine
s) sh
ould
incl
ude
an a
naly
sis o
f bar
riers
to
deve
lopm
ent.
1.1.
2 Co
nduc
t and
impr
ove
dise
ase
surv
eilla
nce
of e
xist
ing
path
ogen
s and
opt
imiz
e m
etho
ds to
det
ect n
ew p
atho
gens
to
cont
inuo
usly
info
rm th
e pr
iorit
ies f
or p
oten
tial n
ew v
acci
nes.
Obj
ectiv
e 1.
2: .
Supp
ort r
esea
rch
to d
evel
op a
nd m
anuf
actu
re n
ew v
acci
ne c
andi
date
s an
d im
prov
e cu
rrent
vac
cine
s to
prev
ent i
nfec
tious
dise
ases
Obj
ectiv
e 1.
3:Su
ppor
t res
earc
h on
nov
el a
nd im
prov
ed v
acci
ne d
eliv
ery
met
hods
.O
bjec
tive
1.5:
Supp
ort p
rodu
ct d
evel
opm
ent,
eval
uatio
n, a
nd p
rodu
ctio
n te
chni
ques
of
vac
cine
can
dida
tes a
nd th
e sc
ient
ific
tool
s nee
ded
for t
heir
eval
uatio
n.
53U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
1.5.
5 Es
tabl
ish a
nd st
reng
then
pub
lic a
nd p
rivat
e pa
rtne
rshi
ps to
ad
dres
s urg
ent n
eeds
in v
acci
ne re
sear
ch a
nd d
evel
opm
ent.
Obj
ectiv
e 5.
3:Su
ppor
t int
erna
tiona
l org
aniz
atio
ns a
nd c
ount
ries t
o in
trod
uce
and
mak
e av
aila
ble
new
and
und
erut
ilize
d va
ccin
es to
pre
vent
dise
ases
of
publ
ic h
ealth
impo
rtan
ce.
5.3.
1St
reng
then
cap
acity
at t
he c
ount
ry le
vel,
and
in m
ultil
ater
al
inst
itutio
ns a
s app
ropr
iate
, to
mak
e in
form
ed d
ecisi
ons
on in
trod
uctio
n of
new
vac
cine
s bas
ed o
n ev
alua
tion
of
epid
emio
logy
, fina
ncia
l sus
tain
abili
ty, s
afet
y, an
d pr
ogra
mm
atic
co
nsid
erat
ions
, inc
ludi
ng su
ppor
t to
natio
nal a
dviso
ry
com
mitt
ees.
5.3.
2Co
llabo
rate
with
glo
bal o
rgan
izat
ions
and
par
tner
s to
acce
lera
te c
linic
al te
stin
g an
d lic
ensu
re in
dev
elop
ing
coun
trie
s of
vac
cine
s alre
ady
licen
sed
in d
evel
oped
cou
ntrie
s, w
here
ap
prop
riate
.5.
3.3
Supp
ort t
he in
tegr
atio
n of
new
and
und
erut
ilize
d va
ccin
es
into
eac
h G
AVI-e
ligib
le c
ount
ry’s
mul
ti-ye
ar n
atio
nal p
lan
of
actio
n an
d pr
ovid
e tr
aini
ng a
nd lo
gist
ical
supp
ort n
eces
sary
to
succ
essf
ully
inco
rpor
ate
new
vac
cine
s int
o ro
utin
e pr
ogra
ms.
5.3.
4Su
ppor
t pos
t-lic
ensu
re e
valu
atio
ns o
f new
vac
cine
s with
rega
rd
to im
mun
izat
ion
prog
ram
s, di
seas
e pa
tter
ns, a
nd v
acci
ne
safe
ty.
5. P
riorit
ies m
ay re
late
to o
bjec
tives
and
stra
tegi
es w
ithin
mul
tiple
Nat
iona
l Vac
cine
Pla
n go
als.
With
in th
e N
atio
nal V
acci
ne P
lan
Impl
emen
tatio
n pr
iorit
ies a
re p
rese
nted
the
mos
t re
leva
nt g
oal.
54 U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
5.3.
5W
ork
with
glo
bal p
artn
ers t
o es
tabl
ish a
n in
tern
atio
nal s
yste
m
that
faci
litat
es ra
pid
resp
onse
to e
mer
ging
infe
ctio
ns th
roug
h th
e de
velo
pmen
t of v
acci
ne re
fere
nce
stra
ins a
nd c
andi
date
va
ccin
es.
5.3.
6W
ork
with
glo
bal p
artn
ers t
o se
cure
and
mai
ntai
n ad
equa
te
stoc
kpile
s/st
rate
gic
rese
rves
of v
acci
nes t
o m
aint
ain
unin
terr
upte
d su
pply
and
for e
mer
genc
y re
spon
se to
ou
tbre
aks.
5.3.
7Su
ppor
t and
dev
elop
mec
hani
sms f
or ra
pidl
y m
akin
g va
ccin
es a
vaila
ble
to d
evel
opin
g co
untr
ies f
or p
ublic
hea
lth
emer
genc
ies s
uch
as p
ande
mic
influ
enza
, inc
ludi
ng e
xplo
ring
optio
ns fo
r sha
ring
of v
acci
nes a
nd ti
ered
pric
ing.
Obj
ectiv
e 5.
5: S
uppo
rt th
e de
velo
pmen
t of r
egul
ator
y en
viro
nmen
ts a
nd
man
ufac
turin
g ca
pabi
litie
s tha
t fac
ilita
te a
cces
s to
safe
and
effe
ctiv
e va
ccin
es in
all
coun
trie
s.5.
5.1
Prom
ote
and
supp
ort t
he e
ffort
s of W
HO
and
oth
er g
loba
l pa
rtne
rs to
dev
elop
and
har
mon
ize
inte
rnat
iona
l sta
ndar
ds fo
r va
ccin
e de
velo
pmen
t and
lice
nsur
e.5.
5.2
Prom
ote
and
supp
ort t
he e
ffort
s of W
HO
and
oth
ers t
o im
prov
e re
gula
tory
cap
acity
in c
ount
ries w
ith li
mite
d in
frast
ruct
ures
to a
ssur
e va
ccin
e qu
ality
, eva
luat
e ne
w v
acci
nes
whe
n ap
prop
riate
, and
ass
ure
that
clin
ical
tria
ls ar
e co
nduc
ted
in a
ccor
danc
e w
ith G
ood
Clin
ical
Pra
ctic
es.
55U.S. Department of Health & Human Services | National Vaccine Plan Implementation
App
endi
x: P
rior
itie
s fo
r Im
plem
enta
tion
and
Rel
ated
Nat
iona
l Vac
cine
Pla
n G
oals
, O
bjec
tive
s, a
nd S
trat
egie
s (c
ontin
ued)
Prio
rity
Rela
ted
Goa
l(s)
Rela
ted
Obj
ectiv
es a
nd S
trat
egie
s
5.5.
3 Pr
ovid
e te
chni
cal a
ssist
ance
to d
evel
opin
g co
untr
y va
ccin
e m
anuf
actu
rers
to su
ppor
t dev
elop
men
t and
pro
duct
ion
of sa
fe
and
effec
tive
vacc
ines
.O
bjec
tive
5.6:
Bui
ld a
nd st
reng
then
mul
tilat
eral
and
bila
tera
l par
tner
ship
s and
oth
er
colla
bora
tive
effor
ts to
supp
ort g
loba
l im
mun
izat
ion
and
erad
icat
ion
prog
ram
s.5.
6.1
Part
icip
ate
in e
stab
lishi
ng g
loba
l im
mun
izat
ion
prio
ritie
s, go
als
and
obje
ctiv
es a
nd p
rovi
de te
chni
cal a
ssist
ance
at g
loba
l, re
gion
al, a
nd n
atio
nal l
evel
s.5.
6.2
Stre
ngth
en in
tern
atio
nal c
olla
bora
tions
for b
asic
and
app
lied
rese
arch
and
rela
ted
trai
ning
of n
ext g
ener
atio
n re
sear
cher
s, es
peci
ally
in d
iseas
e en
dem
ic a
reas
, to
incl
ude
impr
ovin
g th
e st
abili
ty a
nd p
erfo
rman
ce o
f cur
rent
vac
cine
s.5.
6.3
Cont
ribut
e to
dev
elop
men
t and
impl
emen
tatio
n of
a p
lan
esta
blish
ing
the
scie
ntifi
c ba
sis fo
r VPD
era
dica
tion/
elim
inat
ion,
id
entif
ying
opt
imal
vac
cina
tion
appr
oach
es, a
nd d
evel
opin
g st
rate
gies
to m
inim
ize
risks
in th
e po
st-e
radi
catio
n pe
riod.
5.6.
4Pa
rtic
ipat
e in
regi
onal
imm
uniz
atio
n in
itiat
ives
, suc
h as
thos
e ad
opte
d by
the
Pan
Amer
ican
Hea
lth O
rgan
izat
ion
and
othe
r W
HO
regi
ons.
5.6.
5.St
reng
then
vac
cina
tion
of g
loba
lly m
obile
pop
ulat
ions
thro
ugh
targ
eted
pro
gram
s (e.
g., p
re-d
epar
ture
vac
cina
tion
of U
S bo
und
refu
gees
).