Prioritizing Pandemic Influenza Vaccination: Public Values and Public Policy

1. Prioritizing Pandemic Influenza Vaccination: Public Values and Public Policy Benjamin Schwartz, M.D. National Vaccine Program Office, DHHS

2. 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

3. 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 for allocation decisions later” Kathy Kinlaw, MDiv, Emory Univ. CDC Ethics Subcommittee

4. 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

5. ACIP/NVAC priority groups Personnel Cumulative Tier 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

6. 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

7. 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

8. 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

9. 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 • 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-pandemic-wg_v8-011707.pdf

10. 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

11. 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

12. 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

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

14. 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

15. Decision analysis: Selected results General population: Infants & toddlers (30); young children (29); older children (24); pregnant women (20); elderly (18)

16. Decision analysis: Stratified results

17. 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

18. 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

19. 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

20. Vaccine Prioritization Tiers and Target Groups Tier 1 Tier 2 Tier 3 Tier 4 Tier 5 Not targeted (Vaccinated in General pop.)

21. Critical Infrastructure Tiers and Target Groups

22. Critical Infrastructure Influenza Vaccine Prioritization for a Severe Pandemic

23. Steps in pandemic vaccine implementation Prioritization • 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 Production Allocation Distribution Administration Monitoring

24. 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