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
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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

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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

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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

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ACIP/NVAC priority groups

• Personnel Cumulative
• Tier and population groups ( 1,000s)
  total (1,000s)
• 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 lt6 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

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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

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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

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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
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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 Transportatio
n 100,185 Water and Wastewater 608,000
TOTAL 12,389,977

• Notes
• Numbers include Tier 1 essential employees
  only.
• State and local government numbers removed from
  gross and priority workforce numbers.

http//www.dhs.gov/xlibrary/assets/niac/niac-pande
mic-wg_v8-011707.pdf
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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

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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

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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

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Value of pandemic vaccination goals public(Las
Cruces, Nassau Co.) and stakeholder (DC) meeting
results (7-point scale)
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Decision 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

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Decision analysis Selected results
General population Infants toddlers (30)
young children (29) older children (24)
pregnant women (20) elderly (18)
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Decision analysis Stratified results
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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

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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

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Vaccination tiers for a severe pandemic
300 M
123 million
74 million
64 million
16 million
23 million
Tier 1 Tier 2
Tier 3 Tier 4
Tier 5
Vaccination tiers
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Vaccine Prioritization Tiers and Target Groups
Tier 1 Tier 2 Tier 3 Tier 4 Tier 5 Not
targeted (Vaccinated in General pop.)
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Critical Infrastructure Tiers and Target Groups
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Critical Infrastructure Influenza Vaccine
Prioritization for a Severe Pandemic
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Steps 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
Production
Allocation
Distribution
Administration
Monitoring
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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