Transcript Slide 1

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
• 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
Initiatives to increase pandemic
influenza vaccine availability
“Preparedness now decreases the need for
allocation decisions later” Kathy Kinlaw, MDiv, Emory Univ.
CDC Ethics Subcommittee
• 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
Pandemic vaccine prioritization
2005: ACIP/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 groups
Tier and population groups
1A. Health care involved in direct patient
contact + essential support
Vaccine and antiviral drug manufacturing
personnel
Personnel
( 1,000’s)
9,000
Cumulative
total (1,000’s)
9,000
40
9,040
1B. Highest risk groups
25,840
34,880
1C. Household contacts of children <6 mo, severely
immune compromised, and pregnant women
10,700
45,580
151
45,731
59,100
8,500
104,831
113,331
500
113,831
1D. Key government leaders + critical public
health pandemic responders
2. Rest of high risk
Most CI and other PH emergency responders
3. Other key government health decision
makers + mortuary services
4. Healthy 2-64 years not in other groups
179,260 293,091
Rationale for reconsideration of
pandemic 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 analysis of critical
infrastructure (CI) for a U.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
groups: all sectors, tier 1 only
Employees: Tier 1 Only
Banking & Finance: 417,000
Chemical: 161,309
Commercial Facilities: 42,000
Communications: 396,097
Electricity: 50,000
Emergency Services: 1,997,583
Food and Agriculture: 500,000
Healthcare: 6,999,725
Information Technology: 692,800
Nuclear: 86,000
Oil and Natural Gas: 223,934
Postal and Shipping: 115,344
Transportation: 100,185
Water and Wastewater: 608,000
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
TOTAL: 12,389,977
Notes:
a.
Numbers include Tier 1 “essential” employees only.
b.
State and local government numbers removed from gross and priority workforce numbers.
http://www.dhs.gov/xlibrary/assets/niac/niac-pandemic-wg_v8-011707.pdf
Ethics Considerations by the
Interagency 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
Public engagement and stakeholder
meetings: Rationale
• 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 meetings
• 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
Value of pandemic vaccination goals: public
(Las Cruces, Nassau Co.) and stakeholder (DC)
meeting results (7-point scale)
Las
Cruces
Nassau
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
Vaccination goal: To protect…
Decision analysis: Approach
• Consider 57 groups
Vaccination goal: To protect…
defined by job, age,
People working to fight pandemic & provide care
and health status
People providing essential community services
People most vulnerable due to jobs
• Interagency group rated
Children
(0 – 3) extent to which each People most likely to spread virus to unprotected
People protecting homeland security
group met occupational
People most likely to get sick or die
objectives
People most likely to be protected by the vaccine
People keeping pandemic out of the U.S.
• CDC and external experts
People providing essential economic services
rated 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
Score
6.5
6.0
5.8
5.5
5.1
4.8
4.7
4.5
4.3
3.9
Decision analysis: Selected results
Group (1 – 10)
Score
Group (11 – 20)
Score
Pub. health responders
90
Medical care aides
72
Medical practitioners
90
Border protection
72
Emerg. med. services
89
Pharmacists
71
Police
84
Diplomats
71
Relief orgs. (Red Cross)
80
Community orgs.
69
National Guard
76
Nursing home staff
68
Fire protection & rescue
75
Government
65
Emergency mgt.
75
Transportation
64
Military
74
Communications
63
Vaccine manufacturer
73
Energy
60
General population: Infants & toddlers (30); young children (29);
older children (24); pregnant women (20); elderly (18)
Decision analysis: Stratified results
Healthcare & Community Suppt
Critical infrastructure
Pub. health responders
Emergency medical services
Healthcare providers
Police & Law enforcement
Relief & community support orgs.
Fire protection
Pharmacists
Vaccine manufacturers
Other healthcare personnel
Energy, water, communications
Homeland & National Security
General Population
Deployed military
Infants and toddlers
Essential support personnel
Pregnant women
Border protection
Children
National guard
High risk adults
Other military
Elderly
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 casefatality rate
Key issues in building the pandemic
vaccine 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
pandemic
300 M
123 million
74 million
64 million
16 million
23 million
Tier 1
Tier 2
Tier 3
Vaccination tiers
Tier 4
Tier 5
Category
Vaccine
Prioritization
Tiers and
Target Groups
Homeland and
national
security
Healthcare and
community
support
services
Tier 1
Tier 2
Tier 3
Critical
infrastructure
Tier 4
Tier 5
Not targeted
(Vaccinated in
General pop.)
General
population
Target group
Estimated
number*
Deployed and mission critical pers.
700,000
Essential support & sustainment pers.
Intelligence services
Border protection personnel
National Guard personnel
Other domestic national security
650,000
150,000
100,000
500,000
50,000
Other active duty & essential suppt.
1,500,000
Public health personnel
Inpatient health care providers
Outpatient and home health providers
Health care providers in LTCFs
300,000
3,200,000
2,500,000
1,600,000
Community suppt. & emergency mgt.
Pharmacists
Mortuary services personnel
600,000
150,000
50,000
Other important health care personnel
300,000
Emergency services sector pers.
(EMS, law enforce .& fire services)
Mfrs of pandemic vaccine & antivirals
2,000,000
Communications/IT, Electricity,
Nuclear, Oil & Gas, and Water
sector personnel
Financial clearing & settlement pers.
Critical operational & regulatory
government personnel
1,750,000
Banking & Finance, Chemical, Food
& Agriculture, Pharmaceutical,
Postal & Shipping, and
Transportation sector personnel
Other critical government personnel
3,000,000
Pregnant women
Infants & toddlers 6–35 mo old
Household contacts of infants < 6 mo
Children 3–18 yrs with high risk cond.
50,000
400,000
400,000
3,100,000
10,300,000
4,300,000
6,500,000
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
Severe
Moderate
Less
severe
Critical Infrastructure Tiers
and Target Groups
Target group
Est. #
• Emergency services
2,000,000
• Mfrs of pandemic vaccine
50,000
& antivirals
• Communications/IT,
1,750,000
Electricity, Nuclear, Oil &
Gas, Water
• Financial clearing &
20,000
settlement
• Critical operational &
400,000
regulatory government
• Banking & Finance,
3,000,000
Chemical, Food & Ag,
Pharma, Postal &
Shipping, Transportation
• Other critical govt
400,000
Severe Moderate
Less
severe
Critical Infrastructure Influenza Vaccine
Prioritization for a Severe Pandemic
Tier Infrastructures
Allocation Rationale
1
Healthcare
Emergency services
~60%
90%
2
Communications/IT
Electricity & Nuclear
Oil & Gas, Water
25%
3
Banking & Finance
Chemical
Food & Agriculture
Pharmaceutical
Postal & Shipping
Transportation
7.5%
• High risk exposures
• Increased burden
• Products/services essential
to all sectors
• Products cannot be stored
• Little fungibility
• Products may be stored
• Demand may decrease
• Greater fungibility
Steps in pandemic vaccine
implementation
Prioritization
• Ongoing planning to address
each step in the process
Production
• Challenges in identifying and
vaccinating target groups
Allocation
Distribution
Administration
Monitoring
– 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
Conclusions: Public values
and 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