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

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U.S. Department of Health & Human Services

Protecting the Nation’s Health through Immunization

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

5U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

7U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

9U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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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10 U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

11U.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.

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.

.

12 U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

13U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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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15U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

.

16 U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

17U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

.

18 U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

19U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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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21U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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/

22 U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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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23U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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.

24 U.S. Department of Health & Human Services | National Vaccine Plan Implementation

25U.S. Department of Health & Human Services | National Vaccine Plan Implementation

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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. 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

).

56 U.S. Department of Health & Human Services | National Vaccine Plan Implementation