prioritizing pandemic influenza vaccination: public values and public policy
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Prioritizing Pandemic Influenza Vaccination: Public Values and Public Policy. Benjamin Schwartz, M.D. National Vaccine Program Office, DHHS. Why prioritize pandemic vaccine?. Everyone will be susceptible Current minimum of ~20 weeks to first pandemic vaccine availability - PowerPoint PPT PresentationTRANSCRIPT
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