Prioritizing Pandemic Influenza Vaccination: Public Values and

Public Policy

Prioritizing Pandemic Influenza Vaccination: Public Values and

Public Policy

Benjamin Schwartz, M.D.National Vaccine Program Office, DHHS

• Everyone will be susceptible

• Current minimum of ~20 weeks to first pandemic vaccine availability

• U.S.-based production capacity currently is not sufficient to make vaccine rapidly for the entire population

• Targeting groups for earlier or later vaccination will best support pandemic response goals to reduce health, societal, and economic impacts

Why prioritize pandemic vaccine?Why prioritize pandemic vaccine?

Initiatives to increase pandemic influenza vaccine availability

• HHS has invested over $1 billion to:

– Increase vaccine production capacity

– Develop and license new vaccine production technologies (e.g., cell culture, recombinants) that will increase surge capacity and reduce time to availability

– Evaluate adjuvanted vaccine formulations

“Preparedness now decreases the need forallocation decisions later”

Kathy Kinlaw, MDiv, Emory Univ.CDC Ethics Subcommittee

Pandemic vaccine prioritization 2005: Pandemic vaccine prioritization 2005: ACIP/NVACACIP/NVAC

• Joint work of HHS vaccine advisory committees• Process included consideration of

– Vaccine supply and efficacy– Impacts of past pandemics by age and risk group– Potential impacts on critical infrastructures – especially

healthcare– Ethical concerns

• Recommendations included in the 2005 HHS pandemic plan – As guidance for State/local planning – To promote further discussions

ACIP/NVAC priority groupsACIP/NVAC priority groups

Personnel CumulativeTier and population groups ( 1,000’s) total (1,000’s)1A. Health care involved in direct patient 9,000 9,000 contact + essential support Vaccine and antiviral drug manufacturing 40 9,040 personnel

1B. Highest risk groups 25,840 34,880

1C. Household contacts of children <6 mo, severely 10,700 45,580 immune compromised, and pregnant women

1D. Key government leaders + critical public 151 45,731 health pandemic responders

2. Rest of high risk 59,100 104,831 Most CI and other PH emergency responders 8,500 113,331

3. Other key government health decision 500 113,831 makers + mortuary services

4. Healthy 2-64 years not in other groups 179,260 293,091

Rationale for reconsideration of Rationale for reconsideration of pandemic vaccine prioritizationpandemic vaccine prioritization

• Evolving planning assumptions

– More severe pandemic; increased absenteeism

• Results from public engagement meetings

– Preserving essential services ranked as top goal over protecting high-risk individuals

• Additional analysis of critical infrastructures (CI)

– National Infrastructure Advisory Council study of CI sectors and vaccination priority groups

Interagency pandemic vaccine prioritization working group process

• Presentation and discussion of:

– Prior ACIP/NVAC recommendations

– Scientific & public health issues

– Analysis & recommendations on critical infrastructure by the National Infrastructure Advisory Council

– National & homeland security issues

• Consideration of ethical issues

• Public engagement & stakeholder meeting

• Decision analysis

National Infrastructure Advisory Council National Infrastructure Advisory Council analysis of critical infrastructure (CI) for a analysis of critical infrastructure (CI) for a

U.S. pandemicU.S. pandemic• Issues considered

– Essential functions of CI and key resource (KR) sectors (e.g., maintain national & homeland security; ensure economic survival; maintain health & welfare)

– Interdependencies between sectors

– Workforces needed to maintain critical functions

• Process

– Survey of CI/KR operators; review of existing data and plans; interviews of subject matter experts

www.dhs.gov/niac

Identifying critical employee Identifying critical employee groups: all sectors, tier 1 onlygroups: all sectors, tier 1 only

Notes: a. Numbers include Tier 1 “essential” employees only.b. State and local government numbers removed from gross and priority

workforce numbers.

Employees: Tier 1 Only Banking & Finance: 417,000

Chemical: 161,309Commercial Facilities: 42,000Communications: 396,097Electricity: 50,000 Emergency Services: 1,997,583 Food and Agriculture: 500,000Healthcare: 6,999,725Information Technology: 692,800Nuclear: 86,000Oil and Natural Gas: 223,934Postal and Shipping: 115,344Transportation: 100,185Water and Wastewater: 608,000

TOTAL: 12,389,977

Tier 1 Statistics Banking & Finance

Chemical

Commercial Facilities

Communications

Electricity

Emergency Services

Food and Agriculture

Healthcare

Information Technology

Nuclear

Oil and Natural Gas

Postal and Shipping

Transportation

Water and Wastewater

Tier 1 Statistics Banking & Finance

Chemical

Commercial Facilities

Communications

Electricity

Emergency Services

Food and Agriculture

Healthcare

Information Technology

Nuclear

Oil and Natural Gas

Postal and Shipping

Transportation

Water and Wastewater

http://www.dhs.gov/xlibrary/assets/niac/niac-pandemic-wg_v8-011707.pdf

Ethics Considerations by the Ethics Considerations by the Interagency Working GroupInteragency Working Group

• Process issues

– Transparency, inclusiveness, reasonableness

• Content issues

– Preserving society – consider before protecting individuals

– Fairness – value all equally; treat all in a priority group the same

– Reciprocity – protect those who assume occupational risk

– Flexibility – reconsider strategy periodically and at the time of a pandemic

• For a rationing strategy to be successful, it must reflect societal values and preferences

• There are conflicting frameworks for deciding who to protect first during a pandemic

• Prevent the most deaths

• Prevent the most years of potential life lost

• Protect adolescents & young adults (“life cycle” approach)

• Protect well-being of society

• There is uncertainty around the impact of different choices

• Need for vaccination to preserve essential services

Public engagement and stakeholder Public engagement and stakeholder meetings: Rationalemeetings: Rationale

• Objective: Consider the potential goals of pandemic vaccination and assign values to each

• Approach• Background presentations

• Group discussions

• Electronic voting

• Participants • Las Cruces, NM – 108 persons; culturally diverse

• Nassau Co., NY – 130 persons; many older adults

• DC – ~90 persons from government, CI sectors, community organizations

Public engagement and Public engagement and stakeholder meetingsstakeholder meetings

Value of pandemic vaccination goals: publicValue of pandemic vaccination goals: public(Las Cruces, Nassau Co.) and stakeholder (DC) (Las Cruces, Nassau Co.) and stakeholder (DC)

meeting results (7-point scale)meeting results (7-point scale)

Vaccination goal: To protect…Las

CrucesNassau County

D.C.

People working to fight pandemic & provide care 6.7 6.0 6.8

People providing essential community services 5.9 5.7 6.5

People most vulnerable due to jobs 5.8 5.6 5.9

Children 5.9 5.7 4.9

People most likely to spread virus to unprotected 5.3 5.3 4.6

People protecting homeland security 4.6 5.2 4.7

People most likely to get sick or die 4.5 4.8 4.8

People most likely to be protected by the vaccine 4.5 5.1 4.0

People keeping pandemic out of the U.S. 4.3 5.3 3.3

People providing essential economic services 3.0 4.2 4.5

Decision analysis: ApproachDecision analysis: Approach

• Consider 57 groups defined by job, age, and health status

• Interagency group rated(0 – 3) extent to which each group met occupational objectives

• CDC and external expertsrated extent to which each group met “science based” objectives– Vaccine effectiveness, risk of severe illness and death, and

likelihood to transmit infection

• Weights applied based on public and stakeholder values

– Sx = O1w1 + O2w2 + … + O10w10

Vaccination goal: To protect… Score

People working to fight pandemic & provide care 6.5

People providing essential community services 6.0

People most vulnerable due to jobs 5.8

Children 5.5

People most likely to spread virus to unprotected 5.1

People protecting homeland security 4.8

People most likely to get sick or die 4.7

People most likely to be protected by the vaccine 4.5

People keeping pandemic out of the U.S. 4.3

People providing essential economic services 3.9

Decision analysis: Selected resultsDecision analysis: Selected results

Group (11 – 20) Score

Medical care aides 72

Border protection 72

Pharmacists 71

Diplomats 71

Community orgs. 69

Nursing home staff 68

Government 65

Transportation 64

Communications 63

Energy 60

Group (1 – 10) Score

Pub. health responders 90

Medical practitioners 90

Emerg. med. services 89

Police 84

Relief orgs. (Red Cross) 80

National Guard 76

Fire protection & rescue 75

Emergency mgt. 75

Military 74

Vaccine manufacturer 73

General population: Infants & toddlers (30); young children (29); older children (24); pregnant women (20); elderly (18)

Decision analysis: Stratified resultsDecision analysis: Stratified results

Critical infrastructure

Emergency medical services

Police & Law enforcement

Fire protection

Vaccine manufacturers

Energy, water, communications

Healthcare & Community Suppt

Pub. health responders

Healthcare providers

Relief & community support orgs.

Pharmacists

Other healthcare personnel

Homeland & National Security

Deployed military

Essential support personnel

Border protection

National guard

Other military

General Population

Infants and toddlers

Pregnant women

Children

High risk adults

Elderly

The Pandemic Severity Index (PSI)The Pandemic Severity Index (PSI)

• Severity of 20th century pandemics differed

• Threats to essential services and security differ by severity

• PSI offers a way to characterize pandemics based on their case-fatality rate

Key issues in building the pandemic Key issues in building the pandemic vaccine prioritization strategyvaccine prioritization strategy

• Multiple important objectives to achieve

– Public values of preserving healthcare & essential services, and protecting persons at occupational risk & children

• Maintaining essential services requires targeting only a portion of the critical infrastructure workforce

• Need to target workers varies with pandemic severity

• The timing and rate of vaccine availability relative to the pandemic wave is unknown

• Draft guidance developed and vetted in additional public & stakeholder meetings and in a web dialogue

Vaccination tiers for a severe pandemicVaccination tiers for a severe pandemic

Vaccination tiers

23 million16 million

64 million

74 million

123 million

300 M

Tier 1 Tier 2 Tier 3 Tier 4 Tier 5

Category Target group Estimatednumber* Severe Moderate Less

severe

Homeland andnationalsecurity

Deployed and mission critical pers. 700,000

Essential support & sustainment pers.Intelligence servicesBorder protection personnelNational Guard personnelOther domestic national security

650,000150,000100,000500,000

50,000

Other active duty & essential suppt. 1,500,000

Healthcare andcommunitysupportservices

Public health personnelInpatient health care providersOutpatient and home health providersHealth care providers in LTCFs

300,0003,200,0002,500,0001,600,000

Community suppt. & emergency mgt.PharmacistsMortuary services personnel

600,000150,000

50,000

Other important health care personnel 300,000

Criticalinfrastructure

Emergency services sector pers. (EMS, law enforce .& fire services)Mfrs of pandemic vaccine & antivirals

2,000,000

50,000

Communications/IT, Electricity, Nuclear, Oil & Gas, and Water sector personnelFinancial clearing & settlement pers.Critical operational & regulatory government personnel

1,750,000

400,000

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

3,000,000

400,000

Generalpopulation

Pregnant womenInfants & toddlers 6–35 mo old

3,100,00010,300,000

Household contacts of infants < 6 moChildren 3–18 yrs with high risk cond.

4,300,0006,500,000

Children 3–18 yrs without high risk 58,500,000

Persons 19–64 with high risk cond. 36,000,000

Persons >65 yrs old 38,000,000

Healthy adults 19–64 yrs old 123,350,000

Tier 1

Tier 2

Tier 3

Tier 4

Tier 5

Not targeted(Vaccinated inGeneral pop.)

Vaccine PrioritizationTiers and Target Groups

Target group Est. # Severe Moderate Lesssevere

• Emergency services• Mfrs of pandemic vaccine

& antivirals

2,000,00050,000

• Communications/IT, Electricity, Nuclear, Oil & Gas, Water

• Financial clearing & settlement

• Critical operational & regulatory government

1,750,000

20,000

400,000

• Banking & Finance, Chemical, Food & Ag, Pharma, Postal & Shipping, Transportation

• Other critical govt

3,000,000

400,000

Critical Infrastructure TiersCritical Infrastructure Tiersand Target Groupsand Target Groups

Critical Infrastructure Influenza Vaccine Critical Infrastructure Influenza Vaccine Prioritization for a Severe PandemicPrioritization for a Severe Pandemic

Tier Infrastructures Allocation Rationale

1 Healthcare

Emergency services

~60%

90%

• High risk exposures

• Increased burden

2 Communications/IT

Electricity & Nuclear

Oil & Gas, Water

25% • Products/services essential to all sectors

• Products cannot be stored

• Little fungibility

3 Banking & Finance

Chemical

Food & Agriculture

Pharmaceutical

Postal & Shipping

Transportation

7.5% • Products may be stored

• Demand may decrease

• Greater fungibility

Steps in pandemic vaccine implementationSteps in pandemic vaccine implementation

• Ongoing planning to address each step in the process

• Challenges in identifying and vaccinating target groups

– Businesses must identify targeted workers & priority status must be validated at vaccination site

– Persons in families will be vaccinated at different times in different tiers

Prioritization

Allocation

Distribution

Production

Administration

Monitoring

Conclusions: Public values Conclusions: Public values and public policyand public policy

“This guidance is the result of a deliberative democratic process. All interested parties took part in the dialogue. We are confident that this document represents the best of shared responsibility and decision-making.”

HHS Secretary Mike Leavitt