pi vaccine allocation guidance

7/21/2019 Pi Vaccine Allocation Guidance

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Guidance on Allocating and Targeting Pandemic

Influenza Vaccine

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

U.S. DEPARTMENT OF HOMELAND SECURITY



Introduction

Effective allocation o pandemic influenza vaccine will play a critical role in preventing influenza andreducing its effects on health and society when a pandemic arrives. Te specific type o influenza thatcauses a pandemic will not be known until it occurs. Developing a new vaccine in response will takeseveral months and pandemic vaccine may not be available when cases first occur in the United States.Moreover, once vaccine production begins, it will not be possible to make enough new vaccine to protect

everyone in the early stages o a pandemic.

Te U.S. Government is taking steps to minimize the need to make vaccine allocation decisions by sup-porting efforts to increase domestic influenza vaccine production capacity. Significant unding is be-ing provided to develop new vaccine technologies that allow production o enough pandemic influenza vaccine or any person in the United States who wants to be vaccinated within six months o a pandemicdeclaration. Until this goal is met, Federal, State, local and tribal governments, communities, and the pri vate sector will need guidance on who should be vaccinated earlier during the pandemic to best protectour people, communities, and country.

Issues to consider in drafing guidance on pandemic influenza vaccination are different and more com-

plex than in developing recommendations or annual vaccination against seasonal influenza. In contrastwith seasonal influenza, during a pandemic nobody in the population is likely to have immunity to the virus, many more people will become ill, and rates o severe illness, complications and death are likelyto be much higher and more widely distributed throughout the population. Te greater requency andseverity o disease will increase the burden on health care providers and institutions and may disruptcritical products and services in health care and other sectors. National and homeland security could bethreatened i illness among military and other critical personnel reduces their capabilities. Because theneeds that must be addressed by pandemic vaccination differ rom seasonal influenza vaccination, theguidance on vaccination differs as well.

Tis guidance is intended to provide strong advice to support planning an effective and consistent pan-

demic response by States and communities. Nevertheless, it is important that plans are flexible as theguidance may be modified based on the status o vaccine technology, the characteristics o pandemicillness, and risk groups or severe disease – actors that will remain unknown until a pandemic actuallyoccurs.

Vaccination will be only one o several tools that can be used to fight the spread o influenza when a pan-demic emerges. Additional approaches include nonpharmaceutical public health measures in commu-nities, businesses, and households to reduce and slow the spread o inection; using antiviral medicationsor treatment and prevention; using acemasks and respirators in appropriate settings; and washing handsand covering coughs and sneezes. Tese strategies will be the initial mainstay o a pandemic responsebeore vaccine is available and continue to have important effects throughout a pandemic. Guidance

around vaccine use is meant to be applied in conjunction with and in the context o these other pan-demic response efforts. More inormation about pandemic planning and response measures is providedat www.pandemicflu.gov .

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How the Guidance was Developed

Te Federal Government developed this guidance through a rigorous and collaborative process thatincluded input rom all interested parties. Hearing opinions rom persons and organizations with a wide variety o interests and concerns is the best way to ensure that allocation o vaccine in the early stages o apandemic is air and provides the best chance or our country to emerge rom a pandemic with minimallevels o illness, death, and disruption to our society and economy.

Tis guidance was drafed by a Federal interagency working group whose members represent all sectorso the government. Te guidance is firmly rooted in the most uptodate scientific inormation avail-able, and directly considers the values o our society and the ethical issues involved in planning a phasedapproach to pandemic vaccination. Inormation considered by the working group included rigorousscientific assessments o pandemics and pandemic vaccines, national and homeland security issues, es-sential community services and the inrastructures and workorces critical to maintaining them, and theperspectives o state and local public health and homeland security experts. Historical analysis o theinfluenza pandemics o 1918, 1957, and 1968 and their effects provided valuable insights to this guid-ance. Ethical considerations presented by an ethicist who served on the working group and by academicethicists also were important to the working group process and deliberations.

Meetings with the public and stakeholders, including businesses and community organizations, providedkey input on public values and priorities. Participants discussed and rated the importance o potential vaccination program objectives based on a severe pandemic scenario. Notably, each o the meetingscame to the same conclusions about which program objectives are most important (outlined in the nextsection).

A ormal decisionanalysis process also was undertaken that considered the objectives o a pandemic vaccination program and the degree to which protecting population groups (defined by their occupa-tion, age, and health status) contributed to meeting those objectives. Based on this process, groups thatranked highest were rontline public health responders, essential health care workers, emergency medi-

cal service providers, and law enorcement personnel. Among the general population groups, inants andtoddlers ranked highest.

For additional inormation on the guidance development process, please reer to Appendix A.

Draf Guidance on Allocating and Targeting Pandemic Influenza Vaccine

Goals and Objectives

Te goal o the pandemic influenza vaccination program is to vaccinate all persons in the United States

who choose to be vaccinated.It is recognized that vaccine supply to meet this goal will likely not be available all at once, but rather, beproduced at a rate that depends on both vaccine characteristics (antigen required) and manuacturingcapacity. Given that influenza vaccine supply will increase incrementally as vaccine is produced dur-ing a pandemic, allocation decisions will have to be made. Such decisions should be based on publiclyarticulated and discussed program objectives and principles. Te overarching objectives guiding vaccineallocation and use during a pandemic are to reduce the impact o the pandemic on health and minimizedisruption to society and the economy.

One o the most important findings o the working group analysis, and the strongest communicationrom the public and stakeholder meetings, was that there is no single, overriding objective or pandemic

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vaccination and no single target group to protect at the exclusion o others. Rather, there are severalimportant objectives and, thus, vaccine should be allocated simultaneously to several groups. Each o themeetings came to the same conclusions about which program objectives are most important:

• Protecting those who are essential to the pandemic response and provide care or personswho are ill,

•

Protecting those who maintain essential community services,• Protecting children, and

• Protecting workers who are at greater risk o inection due to their job.

In addition to these, working group discussions highlighted the important Federal objective o maintain-ing homeland and national security.

General Principles and Guidance on Pandemic Vaccination

• Te need to target vaccine to maintain security, health care, and essential services will depend on

how severe the pandemic is, as rates o absenteeism and the ability to supply essential products andservices will differ or more and less severe pandemics. As a result, groups targeted or earlier vac-cination will differ by pandemic severity.

• Allocation o pandemic vaccines to States will be in proportion to the State’s population.

• States should ollow the national guidance to ensure airness and uniormity across the UnitedStates and decrease conusion. Within the parameters o the guidance, a small proportion o eachState’s vaccine allocation may be maintained at the State level or distribution based on the specificneeds o that jurisdiction.

• In past pandemics, groups at increased risk or serious illness and death have differed by age and

health status. Specifically, during the 1918 pandemic previously healthy, young adults were a highrisk group. Because the highrisk groups in the next pandemic are not known, planners shouldconsider how the guidance might be modified or this and other pandemic scenarios. At the timeo the pandemic, national leaders will obtain advice rom scientific and public health experts todetermine whether the guidance should be modified based on the characteristics o the emergingpandemic.

• Guidance on pandemic vaccine allocation and targeting will be reassessed periodically beore apandemic occurs to consider the new scientific advances, changes in vaccine production capacity,and advances in other medical and public health response measures.

Framework or Targeting Pandemic Influenza Vaccine

Guidance or targeting vaccination was developed in a structure that defines target groups in our broadcategories that correspond with the objectives o a pandemic vaccination program – to protect peoplewho: 1) maintain homeland and national security, 2) provide health care and community support services, 3) maintain critical inrastructure, and 4) are in the general population.

Each category includes specific target groups that are defined based on their occupation or, or the gen-eral population, by their age and health status. Every person in the United States is included in one ormore o these groups. arget groups are vaccinated in tiers, with all groups in a tier vaccinated simulta-neously unless vaccine supply is so limited that subprioritization is needed. Reflecting public values and

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the need to address multiple important objectives with the pandemic vaccination program, each o thetop tiers includes target groups rom all our categories or a severe pandemic.

Finally, groups in vaccination tiers differ depending on pandemic severity, as threats to security, society,and the economy will be less in less severe pandemics. Te Pandemic Severity Index (PSI) defines cat-egories o pandemic severity based on the proportion o individuals with pandemic illness who die (the“case atality rate”). Pandemic severity will be determined soon afer its initial outbreak based on sur-

veillance o cases and their outcomes beore large areas o the world are affected. Government organiza-tions will use the PSI to determine how best to implement responses such as vaccination and communitystrategies to reduce disease transmission. For a diagram and additional inormation on the PSI, pleasereer to Appendix B.

Guidance Framework At-A-Glance

Target Groups – People targeted or vaccination defined by a common occupation, typeo service, age group, or risk level.

Categories – Pandemic vaccination target groups are clustered into our broad categories(homeland and national security, health care and community support services, critical in-rastructures, and the general population). Tese our categories together cover the entirepopulation.

Tiers – Across categories, vaccine will be allocated and administered according to tierswhere all groups designated or vaccination within a tier have equal priority or vaccina-tion. Groups within tiers vary depending on pandemic severity.

Defining who is included in each target group

Everyone in the United States is included in at least one vaccination target group. People who are notincluded in an occupational group will be vaccinated as part o the general population based on their ageand health status. When a person is included in more than one target group, they will be vaccinated inthe highest tier group in which they are included.

Occupationally defined vaccination target groups (those defined in the Homeland and National Security,Health Care and Community Support Services, and Critical Inrastructure categories) include only per-

sons who are critical or providing essential services during a pandemic, not the entire workorce. Prelimi-nary identification o critical unctions was partly based on an analysis o critical sectors and workorcesconducted by the U.S. Department o Homeland Security’s National Inrastructure Advisory Council(NIAC) (www.dhs.gov/niac), along with input rom Federal agencies. Further work is being undertakento more specifically define critical occupations whose members should receive early vaccination and toprovide guidelines to employers on the proportion o their workorce that may be prioritized or vaccina-tion. Because a pandemic differs rom other national emergencies in the threats it poses and the durationover which it will affect our nation and communities, target groups within each sector may be differentrom those defined in other emergency response planning.

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It should be noted that members o occupational target groups are defined by the unctions personswithin that target group are anticipated to perorm during the pandemic outbreak; it does not distinguishamong staff perorming these duties as part o their usual unctions, those being reassigned to perormthe unction as a new response role, or those perorming the unction as a volunteer. It should also benoted that vaccine does not replace, but adds to other measures taken to protect the workorce and gen-eral population.

Te primary objective o vaccinating persons in critical inrastructure sectors is not to reduce absentee-ism generally through an incremental reduction in pandemic illness afforded by vaccination. Rather, vaccination is targeted to protect workers with critical skills, experience, or licensure status whose ab-sence would create bottlenecks or collapse o critical unctions, and to protect workers who are at espe-cially high occupational risk. Other pandemic response strategies (e.g., engineering controls in work-places, changing work practices to reduce close contact with others, use o personal protective equipmentsuch as acemasks, good handwashing, etc.), and worker education are likely to have greater overalleffects in decreasing absenteeism.

For additional inormation on the definition o groups in each category, the rationales or how groups areordered, and the estimated size o the target population, please reer to Appendix C.

Guidance or Prioritizing Pandemic Vaccination

National guidance or prioritizing pandemic influenza vaccination is provided in able 1. In general, allgroups designated or vaccination within a tier have equal priority or vaccination. Vaccine allocationwithin a tier will be proportional to the populations o the targeted groups, though changes in this alloca-tion scheme at the time o the pandemic may occur based on vaccine supply, the impacts o the pandem-ic, and the specific needs identified at that time.

Vaccination priorities are tailored to pandemic severity in order to best achieve national pandemic re-sponse goals and objectives. Pandemics are defined as “severe” (PSI categories 4 or 5), “moderate” (PSI

category 3), and “less severe” (PSI categories 1 and 2). Figure 1 illustrates pandemic vaccination tiers andtarget groups or a severe pandemic.

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Table 1. Vaccination target groups, estimated populations, and tiers or severe, moderate and less severepandemics as defined by the Pandemic Severity Index (PSI). Persons in occupational groups not specifi-cally targeted or vaccination in Moderate and Less Severe pandemics are targeted according to their ageand health status in the general population.

Tier 1 Tier 2

Category Target Group

Homeland and Deployed and mission critical personnelnational security Essential support & sustainment personnel

Intelligence servicesBorder protection personnelNational Guard personnelOther domestic national security personnelOther active duty & essential support

Health care and Public health personnelcommunity Inpatient health care providerssupport services Outpatient and home health providers

Health care providers in LCFsCommunity support & emergency managementPharmacistsMortuary services personnelOther important health care personnel

Critical Emergency services sector personnelinrastructure

Banking & Finance, Chemical, Food & Agriculture, Pharmaceutical, Postal & Shipping, and ransportation sector personnelOther critical government personnel

General Pregnant womenpopulation Inants & toddlers 6–35 mo old

Household contacts o inants < 6 moChildren 3–18 yrs with high risk conditionChildren 3–18 yrs without high riskPersons 19–64 with high risk conditionPersons >65 yrs oldHealthy adults 19–64 yrs old

Tier 3 Tier 4 Tier 5

Estimated Number*

700,000650,000150,000100,000500,000

50,0001,500,000

300,0003,200,0002,500,000

1,600,000600,000150,000

50,000300,000

2,000,000 (EMS, law enorcement and fire

services)Mrs o pandemic vaccine & antiviralsCommunications/I, Electricity, Nuclear, Oil & Gas, and Water sector personnelFinancial clearing & settlement personnelCritical operational & regulatory

government personnel

Not Targeted**

Severity o Pandemic

LessSevere Moderate severe

50,0002,150,000

3,400,000

3,100,00010,300,000

4,300,0006,500,000

58,500,00036,000,00038,000,000

123,350,000

*Estimates rounded to closest 50,000. Occupational target group population sizes may change as plans are developed urther or implementationo the pandemic vaccination program

**Persons not targeted or vaccination in an occupational group would be vaccinated as part o the General Population based on their age andhealth status.

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Figure 1. Vaccination tiers and target groups or a severe pandemic. Tis figure illustrates how vaccina-tion is administered by tiers until the entire U.S. population has had the opportunity to be vaccinated,and how tiers integrate target groups across the our categories balancing vaccine allocation to occupa-tionally defined groups and the general population.

Population

Rest of population300

High risk population

- High risk adults

- Elderly

74 million

123 million

Critical occupations

- Military support

- Border protection Critical occupations

- Other active duty- National Guard- Other healthcare- Intelligence services- Other CI sectors- Other natl. security- Other govt.- PharmacistsCritical occupations

- Mortuary services High risk population- Deployed forces- Community services - Healthy children- Critical healthcare- Utilities- EMS- Communications- Fire- Critical govt.- PoliceHigh risk populationHigh risk population- Infant contacts- Pregnant women- High risk children- Infants

- Toddlers 15 million

64 million

24 million

Tier 1 Tier 2 Tier 3 Tier 4 Tier

Vaccination tier

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Vaccination Tier 1 at All Pandemic Severities

ier 1 includes the highest priority groups identified in each o the our categories (able 1). Unlikeother tiers where the groups that are targeted differ with severity o the pandemic, ier 1 is the sameacross all pandemic severities. Tis is because or the occupationally defined groups in this tier, main-taining effectiveness is critical, burdens are likely to be markedly increased in any pandemic, and the risko occupational exposure and inection is high because o contact with ill persons, living conditions, or

geographic location. It should be noted that during the 1918 pandemic, more American soldiers died oillness than in combat during the First World War.

argeting vaccination in ier 1 to groups that serve important societal needs is balanced by includingin this tier pregnant women and inants, who are at high risk o dying during a pandemic Protectingpregnant women and inants is in keeping with priorities expressed by public and stakeholder groupsand is an efficient use o vaccine because a pregnant woman may pass on protection to her newborn andbecause inants between 6 and 35 months old may need a smaller vaccine dose compared with olderpersons.

Potential subprioritization o Tier 1

Vaccine may be in extremely short supply through the first wave o a pandemic and even longer. Particu-larly in a severe pandemic, it may be necessary to subprioritize vaccination o groups included in ier 1by stratiying within and between target groups (able 2). For example, hospitalbased health care providers are separated into “rontline” providers – those essential or maintaining emergency departmentsand intensive care units and providing medical and nursing care on inpatient wards – and other inpatienthealth care providers who would receive vaccine later in ier 1. Tis proposed ranking o groups withinier 1 balances allocation to achieve multiple pandemic response goals and protects persons who are athighest occupational risk o becoming inected.

Table 2. Sub-prioritization o vaccination among Tier 1 target groups or situations where vaccine

supply is very limited.

EstimatedPriority Group Rationale Population

1 Frontline inpatient and Critical role in providing care or the sickest 1,000,000hospitalbased health persons; highest risk o exposure andcare workers (persons occupational inectionessential or maintainingunction in emergencydepartments, intensivecare units, and otherrontline medical andnursing staff)

2 Deployed and mission Essential role in national and homeland security; 700,000critical personnel high risk due to living conditions and possibly

geographic location

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3 Frontline Emergency Provide critical medical care including 800,000Medical Service personnel procedures such as intubation that increase risk(those providing patient o aerosol exposure and occupational inectionassessment, triage, andtransport).

4 Frontline outpatient Effective outpatient care is critical to decrease 1,000,000

health care providers the burden on hospitals; high risk o exposure(physicians, nurses, and occupational inectionrespiratory therapy;includes public healthpersonnel who provideoutpatient care orunderserved groups)

5 Frontline fire and law Essential to public order and saety; less 1,000,000enorcement personnel substantial and more predictable risk o

exposure.

6 Pregnant women and Highrisk documented in prior pandemics 5,150,000*inants 611 months old and annually; reflects public values to protect

children; vaccination o a pregnant woman alsowill protect the inant; inants 611 months oldare at highrisk and antiviral drugs are not FDAapproved or children <1 year old

7 Others in ier 1 (includes Includes persons in critical settings who have 14,100,000**ier 1 health care less exposure and toddlers who are less at risk oworkers not vaccinated severe disease or death than younger inants andpreviously in hospitals, who are able to receive antiviral treatment based

outpatient settings, home on FDA approval o antiviral drugshealth, longterm careacilities, and publichealth; emergency serviceproviders; manuacturerso pandemic vaccine,antiviral drugs, and otherkey pandemic responsematerials; and children1235 months old)

*Because inants would be expected to receive onehal a regular vaccine dose, the number o adult vaccine doseequivalentsor this group would be about 4,125,000

**oddlers 12 – 35 months old may receive a lower vaccine dose; thus, the number o adult vaccine doseequivalents or thisgroup may be less.

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Vaccination Tier 2 through 5 by Pandemic Severity

In contrast with ier 1, target groups included in iers 2 through 5 will be different depending on pan-demic severity (see able 1). When vaccination has been completed or all five tiers, at any pandemicseverity, everyone in the United States will have had the chance to be vaccinated.

Guidance or severe pandemics (PSI 4 or 5)

ier 2 targets groups in the Homeland and National Security category that are critical to maintaining ourcountry’s saety. Critical community support service personnel are prioritized because they are needed toassist in a community pandemic response and support vulnerable populations such as the elderly, per-sons living alone, and amilies complying with voluntary quarantine when a amily member is ill (recom-mended as part o the community mitigation strategy). Pharmacists and mortuary services personnelalso are targeted because o the critical services they provide and the potential or exposure to ill persons.Critical inrastructures targeted in ier 2 are those that provide “just in time services” (i.e., products likeelectricity and natural gas that cannot be stored), are relied on by all other inrastructures or their es-sential operations, and contribute to public health and saety. Te highest risk children – those who haveunderlying medical conditions that increase their risk o complications or death rom influenza inec-

tions – also are included in this tier.

ier 3 includes the remaining target groups that protect homeland and national security, provide healthcare, and maintain critical inrastructures. Critical Inrastructure sectors targeted in ier 3 are those thatprovide essential products and services where there generally is greater “redundancy” in inrastructure(e.g., there are many bakeries, dairies, gas stations) or personnel (e.g., there are many truck drivers); orwhere burden is likely to decrease in a pandemic (e.g., less demand or mass transit, postal, and shippingservices). Many businesses in these sectors can take other measures to protect employees, such as usingalternate work schedules, teleworking, and reducing inperson meetings and other contacts in the work-place. In the general population, children without highrisk medical conditions are targeted in this tier.

iers 4 and 5 are ocused on groups in the general population that have not yet been vaccinated. Whereaspersons aged 19 to 64 years who have underlying medical conditions and elderly persons 65 years old orolder are targeted in ier 4, in situations o limited vaccine supply, the 19 to 64 year old group should betargeted first. Te rationale or targeting younger persons is that the effectiveness o seasonal and candi-date pandemic influenza vaccines is less among elderly persons because o agerelated decreases in im-mune unction. Tus, when vaccine supply is limited, targeting highrisk adults beore the elderly makesbest use o the supply that is available. Other strategies, including hygiene and public health measures toreduce the risk o inection, and treatment with antiviral medications are effective options to protect theelderly. Healthy adults would be targeted in ier 5.

In some pandemic scenarios, prioritizing younger adults beore those who are older may be appropri-

ate. During the 1918 pandemic, the risk o death among young, previously healthy adults was similar orgreater than that among the elderly. In a severe pandemic, targeting younger adults first also may haveseveral advantages: working age adults contribute more to maintenance o societal unctions and eco-nomic wellbeing; they provide most care or children; and they have a higher risk o inection becauseo their greater number o contacts at work and in the amily. Based on these considerations, most o theparticipants in the public engagement sessions suggested vaccinating younger adults beore the elderly.However, given the much higher risk o severe illness and death experienced by older adults in two othe previous three pandemics and or seasonal influenza inection, the working group recommends thatplans target older adults beore younger healthy adults. Nevertheless, pandemic planners should con-sider developing and exercising alternate plans to be prepared or either situation.

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Guidance or moderate pandemics (PSI 3)

Moderate pandemics also pose threats to maintaining security, providing healthcare and communitysupport services, and to critical inrastructures. While target groups in ier 1 are the same as or severepandemics, in later tiers, general population groups assume greater priority.

arget groups in ier 2 or homeland and national security, health care and community support ser-

vices, and critical inrastructure are the same as or a severe pandemic (able 1). However, or moderatepandemics this tier includes all children 3 to 18 years old, as well as household contacts o young inants.Because o the large population o children, i vaccine supply is limited, children with medical conditionsthat increase their risk o severe illness should be vaccinated beore those without such conditions.

ier 3 includes the remaining target groups that protect homeland and national security, and providehealthcare and community support. Vaccination is not targeted to critical inrastructure personnel in theremaining sectors because a moderate pandemic poses less risk to maintenance o important unctionsamong inrastructures where there is more redundancy o unctions and personnel. Tereore, peoplewho would have been targeted in ier 3 in this category or a severe pandemic would be vaccinated aspart o the general population based on their age and health status. ier 3 also includes persons aged 19

to 64 years who are at higher risk o severe illness due to underlying medical conditions and persons 65years old and older. Similar to the situation or severe pandemics, i vaccine supply is limited, the highrisk adults should be targeted beore the elderly because o the greater vaccine effectiveness in the ormergroup. Healthy adults are included in ier 4.

Guidance or less severe pandemics (PSI 1 or 2)

Less severe pandemics pose less threat to delivery o health care, community support, and other essen-tial services and products. While target groups in ier 1 are the same as or severe pandemics, in later vaccination tiers, general population groups assume greater priority. Historical analysis o the 1957 and1968 pandemics in the United States indicates that health care and essential services were effectively

maintained. Because o this, afer ier 1, occupational groups in the health care and community supportservices and critical inrastructure categories are not specifically prioritized and workers in these groupswould be vaccinated based on their age and health status as part o the general population.

ier 2 includes groups that protect homeland and national security given the overriding importance oprotecting our country’s security (able 2). In contrast with more severe pandemics where children are vaccinated beore other general population groups, in less severe pandemics, guidance or priority vacci-nation ollows recommendations or annual influenza vaccination as defined by the Advisory Committeeor Immunization Practices. Te rationale is that a PSI Category 1 pandemic may be little different thana bad annual influenza outbreak. Tus, ier 2 includes household contacts o inants less than 6 monthsold and persons with medical conditions that increase their risk or influenza complications, and persons

aged 65 years and older.

ier 3 includes healthy children and ier 4 includes healthy adults, who comprise the remainder o thepopulation.

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Next Steps and What States and Communities Can Do

Tis guidance is the result o careul and rigorous consideration o scientific data, historical analyses, eth-ical issues, and comments rom government agencies, key stakeholders at the national, State, and local/community levels, and members o the general public. Te development o vaccine prioritization guid-ance, however, is only one step toward planning and implementing an effective pandemic vaccinationprogram. Strategies or how persons in occupationally defined target groups should be identified and

how their priority can be verified at the time o vaccination must be developed. State, local, and tribalplanners also must plan or allocation and distribution o vaccine to sites where it will be administered, vaccination clinic procedures, and programs to monitor coverage and potential adverse events. Strategiesand materials also must be developed or employers and the public to clearly communicate the vaccinetargeting strategy and support it’s implementation.

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Appendix A

Additional Inormation on the Draf Guidance Development Process

Tis guidance was developed by a Federal interagency working group whose members represent all sec-tors o our government. Te guidelines are firmly rooted in the most uptodate scientific inormationavailable, balanced with the values o our society and the ethical issues involved in planning a phasedapproach to pandemic vaccination.

In a series o weekly meetings over a three month period, working group members were inormed on thescience o pandemics and pandemic vaccine, including the effects o past pandemics; risk groups or severe influenza illness and death; influenza vaccine production, timing, and capacity; vaccine effectivenessin various population groups; potential indirect effects o vaccination on preventing the spread o diseasein communities (“herd immunity”); and potential strategies and impacts or other pandemic responsemeasures. Representatives rom the U.S. Department o Deense and the U.S. Department o HomelandSecurity (DHS) presented to the working group on critical issues or national and homeland security.State and local public health and homeland security officials presented perspectives on community needs.Planners rom Canada and the United Kingdom described their vaccine allocation plans. Te groupreviewed and discussed recommendations rom Federal advisory committees, including preliminaryguidance on vaccine prioritization that was developed jointly by the U.S. Department o Health and Hu-man Services’ Advisory Committee on Immunization Practices (ACIP) and National Vaccine AdvisoryCommittee (NVAC) in 2005, and findings on critical inrastructures and workorces rom an analysis byDHS’s National Inrastructure Advisory Council (NIAC).

Input rom Stakeholders and the Public

Public and stakeholder input into development o the guidance was obtained in public engagement andstakeholder meetings and rom over 200 written comments submitted in response to a Request or Inor-mation issued in December 2006. Public engagement and stakeholder meetings ocused on discussion o

the goals and objectives o pandemic vaccination and their importance. Participants in allday sessionsheard background presentations on pandemics and pandemic vaccination, took part in small group dis-cussions o potential vaccination program goals and objectives as well as the values underlying them, andrated each on a scale rom “extremely important” to “unimportant” based on a severe pandemic scenario.

Stakeholders and the public identified the same our vaccination program objectives as most importantin all o the meetings:

• Protect persons critical to the pandemic response and who provide care or persons withpandemic illness,

• Protect persons who provide essential community services,

• Protect persons who are at high risk o inection because o their occupation, and

• Protect children.

Other objectives that were considered important included protecting homeland and national security,indirectly protecting persons who cannot be vaccinated, protecting persons at high risk o severe illnessand death, protecting those who have essential economic unctions, protecting persons guarding ourborders, and targeting vaccine to persons among whom it is most likely to be effective.

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Decision Analysis

Te working group undertook a rigorous decision analysis as part o the process to develop draf guid-ance. In this analysis, working group members rated the importance o each o 10 potential vaccinationprogram objectives or a severe pandemic. For vaccination program objectives relating to occupationalunction and risk, working group members independently rated 57 population groups on the degree towhich they met each o the objectives. Separately, influenza experts at the U.S. Centers or Disease Con-

trol and Prevention (CDC) and in academia independently rated groups with respect to sciencebasedobjectives, such as vaccine effectiveness and risk o severe or atal influenza illness. Weighted scores weretotaled across the ten objectives or each group, and groups were ranked in our categories: homeland andnational security, health care and community support services, critical inrastructure, and general popu-lation. Te process was then replicated based on rating o vaccination program objectives or moderateand less severe pandemics.

Groups with the highest overall scores, regardless o pandemic severity, included rontline public healthresponders, essential health care workers, emergency medical service providers, and law enorcementpersonnel. Among the general population groups, inants and toddlers ranked highest.

Ethical Considerations

Underlying the working group’s deliberations was a strong consideration o the ethical issues involved inallocating vaccine when supply is limited. An ethicist rom the National Institutes o Health who partici-pated as a member o the working group and academic ethicists discussed ethical rameworks and theirapplication to decision making on vaccine allocation. Vaccinating some people earlier than others tominimize health and societal impacts o a pandemic was considered ethically appropriate. Other impor-tant principles that were considered were: airness and equity (recognizing that all persons have equal value, and providing equal opportunity or vaccination among all persons in a priority group); reciproc-ity, defined as protecting persons who assume increased risk o becoming inected because o their jobs;and flexibility to assure that vaccine priorities are optimally tailored to the severity o the pandemic andthe groups at greatest risk o severe inection and death.

A second ethical ocus was the importance o developing guidance through an open and transparentprocess with multiple opportunities and avenues or input rom the public and stakeholders. Publicengagement meetings were held in Las Cruces, New Mexico, and Long Island, New York, and includeda diverse group o participants. In addition, stakeholders participated at a meeting in Washington D.C.that included representatives rom private sector businesses and community organizations. Te work-ing group is committed to maintaining an ethical process as comments on the draf guidance are soughtthrough a variety o orums and media.

Vetting the draf guidance with the public and stakeholdersDraf guidance developed through the process described above was posted or public comment in theFederal Register and on the Federal government’s pandemic influenza website (www.pandemicflu.gov)in October 2007. In addition, input was obtained in two public engagement and a stakeholders meet-ing, and in a three day webdialogue. Te approach to the public and stakeholder meetings was similarto that used in developing the guidance but the small group discussions ocused on the proposed vac-cine prioritization recommendations and participants were asked what they thought should be changed.Participants then voted on proposed changes using a scale ranging rom “strongly agree” to “stronglydisagree.” Process or the webdialogue was similar with discussions conducted electronically includingover 400 participants who interacted with interagency working group members and other government

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experts. Inormation rom these meetings and comments in response to the Federal Register and websitenotice were shared with the working group and all proposed changes were considered. Modificationswere made both in the specific priority group recommendations as well as in the general guidance basedon public and stakeholder comments.

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Appendix B

Pandemic Severity Index

Priority groups or receipt o vaccine early in a pandemic may differ with the severity o the pandemic, asdefined by the Pandemic Severity Index (PSI). Te PSI defines five categories o pandemic severity basedon the proportion o persons with pandemic illness who die (the “case atality rate”). Te severity o apandemic will be determined soon afer its initial outbreak by surveillance o cases and their outcomesbeore large areas o the world are affected. Government entities will use the PSI to guide implementationo response measures, including vaccination and community strategies to mitigate disease transmission.

Matching the targeting and intensity o intervention to the severity o a pandemic maximizes the publichealth benefit and avoids adverse consequences. Data on case atality rates early in the course o the nextpandemic will be collected during outbreak investigations o initial clusters o human cases, and publichealth officials may make use o existing influenza surveillance systems once widespread transmissionstarts. Other measures o pandemic severity may be assessed and highest risk populations or severe ill-ness and death will be identified. For more inormation on the PSI, please go to http://www.pandemicflu.gov/plan/community/commitigation.html#IV.

Figure. Pandemic Severity Index categories based on case atality rates o pandemic illness. Note thatthe projected number o U.S. deaths reers to a pandemic in which no response measures are undertaken.Health impacts in the context o an effective response would be much less

*Based on 30% illness Rate

Pandemic Severity IndexCase Projected

Fatality Number of Deaths*Ratio US Population, 2006

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Appendix C

Description and Rationale or Groups Targeted or Pandemic Vaccination

Defining targeted groups in our categories – Homeland and National Security, Health Care and Com-munity Support Services, Critical Inrastructure, and General Population – highlights the multiple,important objectives o a pandemic vaccination program and the U.S. Government’s commitment to ad-dress different needs simultaneously as the program is implemented.

Defining target groups in categories also highlights potential differences in program implementationbetween categories. For example, vaccine or homeland and national security groups may be allocatedto the Departments o Deense, Homeland Security, and other agencies and administered by militaryhealthcare personnel or occupational health providers. Healthcare providers may be vaccinated in theirworkplaces. Large companies, particularly those operating in several States, may have the capacity tocoordinate the vaccination program or their workers. Vaccination o first responders, critical workers atmunicipal utilities, and the general population will be managed by State and local health departments.

Te ables below provide urther definition o target groups or pandemic vaccination, the estimated sizeo the group, and a brie description o the working group’s rationale or prioritizing that group. Note

that persons in occupational groups are only those who are critical to maintaining essential unctions.Work is ongoing to urther assess and hone definitions and population sizes or these groups.

Table 1. Target groups in Homeland and National Security.1

ier(severe

pandemic)

Group Definition EstimatedGroup Size

Rationale

1 Deployed and Military orces and other 700,000 Critical to protect national

mission critical mission critical personnel security; unable to toleratepersonnel not limited to active duty projected pandemic personnelmilitary or USG employees. loss and ulfill mission; potentialIncludes some diplomatic greater risk o inection dueand intelligence service to geographic location andpersonnel, and public and crowded living or workingprivate sector unctions conditionsidentified by Federalagencies as unique andcritical to national security

2 Essential support Military and other essential 650,000 Maintaining unction is

and sustainment personnel needed to support essential to mission successpersonnel and sustain deployed orces or deployed personnel; risko inection may be less romgeographical location and livingconditions

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2 Intelligence Critical personnel in the 150,000 Essential to homeland andservices intelligence community national security; opportunities

serving at domestic and or social distancing limitedinternational posts because o inability to telework

due to need or secure acilities;

some personnel may beat increased risk based ongeographical location

2 Border Critical personnel in 100,000 Essential to homeland security;protection agencies providing U.S. in close contact with manypersonnel border security, including potentially inected persons

but not limited to Customs throughout a pandemic; limitedand Border Protection, ability to apply social distancingBorder Patrol, Immigration strategiesand Customs Enorcement,ransportation Security

Administration, and CoastGuard personnel

2 National Guard National Guard personnel 500,000 Likely to be activated in apersonnel not included above who pandemic to support critical

are likely to be activated response or communityto maintain public order unctions; may be at increasedduring a pandemic or risk o exposure and inectionto support pandemic based on missionresponse services or criticalinrastructure

2 Other domestic Includes other groups that 50,000 Essential to national andnational security are essential to national homeland securitypersonnel security such as guards at

nuclear acilities

3 Remaining Active duty personnel not 1.5 million Important to national andactive duty included in higher priority homeland securitymilitary and groups and essential supportessential support personnelpersonnel

1 Estimates o group size rom Department o Deense, Department o Homeland Security, and rom working grouprepresentatives rom other Federal agencies

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Table 2. Target groups in Health Care and Community Support Services2

◆ 19 ◆

ier(severe

pandemic)Group Definition Estimated

Group SizeRationale

1 Public health Public health responders 300,000 Essential to implementing the

personnel at Federal, State, and pandemic response, includinglocal levels the vaccination program and

other pharmaceutical andnonpharmaceutical responsemeasures; also provide careor poor and underservedpopulations; personnel have a highrisk o exposure to persons withpandemic illness

1 Inpatient Includes twothirds o 3.2 million Maintaining quality inpatienthealth care personnel at acute care health care is critical to reducingproviders hospitals who would mortality rom pandemic

be identified by their influenza and rom other illnessesinstitution as critical to that will occur concurrently withprovision o inpatient the pandemic; inpatient healthhealth care services; care burden will be markedlyprimarily will include increased during a pandemic;persons providing care studies show health outcomes arewith direct patient associated with stafftopatientexposure but also will ratio; personnel have high risk oinclude persons essential exposure, including to inectiousto maintaining hospital aerosols; inected health care

inrastructure personnel may transmit inectionto vulnerable persons hospitalizedor noninfluenza illnesses

1 Outpatient and Includes twothirds o 2.5 million Maintaining outpatient andhome health personnel identified home health care is critical tocare providers by their organization reducing pandemic mortality

at outpatient acilities, and morbidity and reducing theincluding but not limited burden on inpatient services;to physicians’ offices, outpatient health care burden willdialysis centers, urgent be markedly increased duringcare centers, and blood a pandemic; personnel have

donation acilities; and high risk o exposure, possiblyskilled home health care including to inectious aerosols;personnel inected health care personnel may

transmit inection to vulnerablepersons receiving care or noninfluenza illness



1 Health carepersonnel inlongtermcare acilities(LCFs)

Includes twothirdso personnel at LCFsidentified by theirorganization as critical tothe provision o care

1.6 million Essential to provide care to morethan 3 million persons in LCFswho are particularly vulnerable toinfluenza illness and death; risk opandemic outbreaks in LCFs maybest be reduced by vaccinatingstaff and limiting exposure o

residents to inection; i outbreaksoccur, personnel have high risko exposure, possibly including toinectious aerosols

2 Communitysupport servicepersonnel(emergencymanagementandcommunity

and aithbased supportorganizations)

Personnel romcommunityorganizations includingthe Red Cross whowill provide essentialsupport and have directcontact with persons

and amilies affectedduring communitypandemic outbreaks, andemergency managementpersonnel whocoordinate pandemicresponse and supportactivities

600,000 Community level support willbe critical or persons who are illand isolated in their homes or arecomplying with recommendationsor voluntary householdquarantine during communitypandemic outbreaks, or elderly

persons who live alone and maybe araid o going out during apandemic, or persons who arehomeless, and or other vulnerablepopulations; support may includeproviding ood and medications,as well as other social and mentalhealth services; personnel willbe at high risk o exposure to illpersons and, i inected couldtransmit illness to a highriskpopulation

2 Pharmacists Includes pharmacistsdispensing drugs atretail locations (note thatpharmacists in hospitalsor outpatient centersmay be targeted as parto those groups)

150,000 Essential to dispense medicationsor pandemic influenza and otherillnesses; may have increasedexposure risk to persons withpandemic inection

2 Mortuaryservicespersonnel

Includes uneraldirectors

50,000 Increased burden likely duringa pandemic; may have increasedoccupational exposure to ill amily

members o deceased persons

3 Otherimportanthealth carepersonnel

Includes groups thatprovide importanthealth care services butare at less occupationalrisk, such as laboratorypersonnel

300,000 Personnel provide importanthealth care services but are not inas close contact with ill personsand at less risk o occupationalinection

2 Estimates o group size rom Department o Health and Human Services. Community social service provider estimate as-sumes 300,000 volunteers rom national organizations (e.g., Red Cross) and additional allocation o 1 per 1000 population.

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Table 3. Target groups in Critical Inrastructure3

◆ 21 ◆

ier(severe

pandemic)Group Definition Estimated

Group SizeRationale

1 Emergency Includes groups 2 million Provide critical public

services personnel supporting emergency saety and emergency– EMS, fire, law response and public response services;enorcement, and saety. EMS personnel contribute to pandemiccorrections include those who response activities by

are fire department maintaining public orderbased, hospitalbased and contributing to medicalor private; fire fighters care services; increasedinclude proessionals occupational risk orand volunteers; emergency medical serviceslaw enorcement due to exposure to personsincludes local police, with pandemic illnesssheriff ’s officers, and

State troopers; andcorrections officersinclude those at prisonsand jails

1 Manuacturers o Includes critical 50,000 Reducing pandemicpandemic vaccine personnel required or health impacts requiresand antiviral drugs, ongoing production production o pandemic

o pandemic medical vaccine and antiviral drugscountermeasures tosupport a pandemicresponse

2 Communications/ Personnel who are 1.75 million Tese sectors provideI ,Electricity, critical to support products and services thatNuclear, Oil & Gas, essential services generally cannot be stored,and Water sector provided by the defined are required or communitypersonnel, and sectors health and saety, andFinancial clearing are essential to theand settlement unctioning o other criticalpersonnel inrastructure sectors

2 Critical government Federal, State, local,and 400,000 Government personnel are

personnel – tribal government critical or implementingoperational and employees and and monitoringregulatory unctions contractors who components o the

perorm critical pandemic response, andregulatory or perorming regulatoryoperational unctions or operational unctionsrequired or essential essential to criticaloperations o other CI inrastructures that protectsectors public health and saety and

preserve security



3 Banking & Finance, Personnel who are 3.0 million Tese sectors provideChemical, Food critical to support essential products& Agriculture, essential services and services; howeverPharmaceutical, provided by the defined compared with ier 2Postal & Shipping, sectors sectors, products can

and ransportation more likely be stored,sector personnel acilities and personnel

are more ungible andbetter able to maintainessential unctions withhigh absenteeism, andother strategies can beimplemented to protectworkers

3 Other critical Federal, State, local 400,000 Continuity o keygovernment and tribal government government unctions

personnel employees and is important to supportcontractors who communities and criticalperorm important inrastructuresgovernment unctionsincluded in agencycontinuityooperationsplans

3 Group sizes or critical inrastructure sectors are estimated as 25% o the workorce in ier 2 sectors and 7.5% o the work-orce in ier 3 sectors. Tese estimates track generally with estimates rom the NIAC report, Te Prioritization o CriticalInrastructure or a Pandemic Outbreak in the United States (www.dhs.gov/niac) and with estimates provided by the Depart-

ment o Homeland Security. Estimates or Federal, State, local, and tribal government personnel are 5% o workers in ier 2and 5% in ier 3

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Table 4. Target groups in the General Population4

ier(severe

pandemic)

Group Definition EstimatedGroup Size

Rationale

1 Pregnant women Women at any stage o 3.1 million Pregnant women are at high riskpregnancy o severe complications or death

rom pandemic influenza due toimmunological, circulatory, andrespiratory changes that occurduring pregnancy; vaccinatingthe pregnant woman also mayprotect newborn inants dueto passive transer o maternalantibodies

1 Inants and Inants and toddlers in 10.3 million Persons in this age group are attoddlers, 6 – 35 the specified age group high risk o severe complicationsmonths old or death rom pandemic

influenza; vaccination mayrequire a lower dose than used toprotect older children and adultsantiviral medications are notapproved or use in children <1year old; public values prioritizechildren highest among groupsdefined by age and disease status

2 Household Household contacts o 4.3 million Inants under 6 months oldcontacts o inants under 6 months cannot be directly protectedinants under 6 old by vaccination and influenza

months old antiviral drugs are not approvedor this age group; thereore,protecting young inants by vaccinating household contactsis the best option; public valuesprioritize children highest amonggroups defined by age and diseasstatus

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2 Children 3 –18 years oldwith a highrisk medicalcondition

Children in the specifiedage group with a chronicmedical condition thatincreases their risk osevere influenza disease,including heart andlung diseases, metabolic

disease, renal disease,and neuromusculardiseases that maycompromise respiratoryunction, as defined byACIP recommendationsor seasonal influenza vaccination

6.5 million Children with these conditionsare at increased risk o severecomplications or death rominfluenza disease; public valuesprioritize children highest amonggroups defined by age and diseasestatus

3 Children 3 –18 years old

without a highrisk medicalcondition

Children in the specifiedage group not included in

above

58.5 million Public values prioritize childrenhighest among groups defined

by age and disease status; vaccinating children may reducetransmission o pandemicinfluenza to household contactsand in communities; i childrenare protected by vaccine, schoolscan reopen mitigating secondaryadverse consequences o closingschools

4 Highriskpersons 19 – 64

years old

Adults in the specifiedage group with a chronic

medical condition thatincreases their risk osevere influenza disease,including heart andlung diseases, metabolicdisease, renal disease,and neuromusculardiseases that maycompromise respiratoryunction, as defined byACIP recommendationsor seasonal influenza

vaccination

36 million Adults with these conditionsare at highrisk o severe

complications or death rompandemic influenza

4 Persons over 65years old

Elderly adults in thespecified age group

38 million Persons in this group are at highrisk o severe complications ordeath rom pandemic influenza

5 Healthy adults,19 – 64 years old

Adults in the specifiedage group not includedabove

123.4 million Persons in this group lackage, health condition, andoccupational rationales orpriority pandemic vaccination

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4 Estimates o group size based on the U.S. census rom 2000 extrapolated to 2006 (http://www.census.gov/ipc/www/usinterimproj). Te target group “Healthy adults 19 – 64 yrs old” does not include persons defined by occupation and pregnant womenwho are included in other target groups.

pi vaccine allocation guidance

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