1. Draft Guidance on Prioritization of Pandemic Influenza Vaccine Who should get vaccinations first? Benjamin Schwartz, M.D. National Vaccine Program Office, DHHS

2. Why prioritize pandemic influenza vaccinations? 2005 ACIP/NVAC process and recommendations Current prioritization process and draft guidance Next steps Issues to address

3. 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?

4. 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

5. Unclear timing and supply of vaccine for the first pandemic wave Unclear timing of pandemic spread –Mathematical modeling predicts ~55 days to first U.S. case and 80 – 120 days from first case to peak of first wave –Substantial uncertainty Wide range around point estimates Unknown where a pandemic will start Potential impact of seasonality Unclear vaccine supply –Depends on U.S.-based capacity when a pandemic occurs –Depends on antigen concentration per dose For H5N1 vaccines, antigen concentration in clinical trials ranged from 3.8 ug to 90 ug depending on formulation

6. 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

7. ACIP/NVAC priority groups PersonnelCumulative 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 59,100104,831 Most CI and other PH emergency responders 8,500113,331 3. Other key government health decision 500113,831 makers + mortuary services 4. Healthy 2-64 years not in other groups 179,260293,091

8. 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

9. Rationale for an interagency pandemic vaccine prioritization working group Need for broad expertise and input –A pandemic will affect all sectors –Security & CI issues are a major focus Interagency participation facilitates policy approval Charge in the National Implementation Plan “HHS in coordination with DHS and sector specific agencies…shall identify lists of personnel and high-risk groups that should be considered for priority access to medical countermeasures under various pandemic scenarios” National Implementation Plan, Action 6.1.14.2 http://www.whitehouse.gov/homeland/nspi_implementation_chap06.pdf

10. Interagency pandemic vaccine prioritization working group process Presentation and discussion of: –Prior ACIP/NVAC recommendations –Scientific, public health & ethical issues –Analysis & recommendations on critical infrastructure by the National Infrastructure Advisory Council –National & homeland security issues Public engagement & stakeholder meeting Decision analysis Written comments submitted in response to a Federal Register and www.pandemicflu.gov noticewww.pandemicflu.gov

11. Ethics Considerations by the Interagency Working Group Participation by NIH ethicist and ethicists from MN Center for Healthcare Ethics Process issues –Transparency, inclusiveness, reasonableness Content issues –Preserving society considered 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

12. 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

13. Identifying critical employee groups: 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: 161,309 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 http://www.dhs.gov/xlibrary/assets/niac/niac-pandemic-wg_v8-011707.pdf

14. 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 stakeholder meetings

15. Value of pandemic vaccination goals: public (Las Cruces, Nassau Co.) and stakeholder (DC) meeting results (7-point scale) Vaccination goal: To protect… Las Cruces Nassau County D.C. People working to fight pandemic & provide care6.76.06.8 People providing essential community services5.95.76.5 People most vulnerable due to jobs5.85.65.9 Children5.95.74.9 People most likely to spread virus to unprotected5.3 4.6 People protecting homeland security4.65.24.7 People most likely to get sick or die4.54.8 People most likely to be protected by the vaccine4.55.14.0 People keeping pandemic out of the U.S.4.35.33.3 People providing essential economic services3.04.24.5

16. Decision analysis Methods –57 groups considered defined by job, age, and health status –Interagency group rated extent to which each group met occupationally related objectives –CDC and external influenza experts 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 Results –Highest ranked groups included public health responders, HCWs, EMS providers, law enforcement, and children

17. Structure of the draft guidance Vaccination will occur by tiers Target groups are defined in categories –Healthcare and community support services –Critical infrastructure –Homeland and national security –General population Within categories, target groups are clustered in levels –Each group in a level has similar priority for vaccination Tiers combine target groups across categories Target groups are defined based on pandemic severity

18. Vaccination tiers for a severe pandemic Vaccination tiers 23 million 17 million 64 million 74 million 122 million 300 M Tier 1 Tier 2 Tier 3 Tier 4 Tier 5

19. 121,800,000Healthy adults 19–64 yrs old 38,000,000Persons >65 yrs old 36,000,000Persons 19–64 with high risk cond. 58,500,000Children 3–18 yrs without high risk 4,300,000 6,500,000 Household contacts of infants < 6 mo Children 3–18 yrs with high risk cond. 3,100,000 10,300,000 Pregnant women Infants & toddlers 6–35 mo old General population 1,400,000 to 3,500,000 Transportation, Food and agriculture, Banking and finance, Pharmaceutical, Chemical sector, Oil, Postal and shipping personnel Other important govt. personnel 1,900,000 to 4,400,000 Electricity, Natural gas, Communications, Water personnel Critical government personnel 2,000,000 50,000 Emergency Medical Service, Law enforcement, Fire services personnel Mfrs of pandemic vaccine & antivirals Key government leaders Critical infrastructure 500,000Other important health care personnel 600,000Community suppt. & emergency mgt. 300,000 3,200,000 2,000,000 800,000 Public health personnel Inpatient health care providers Outpatient and home health providers Health care providers in LTCFs Health care and community support services 1,500,000Other active duty & essential suppt. 650,000 150,000 100,000 500,000 50,000 Essential support & sustainment pers. Intelligence services Border protection personnel National Guard personnel Other domestic national security pers. 700,000Deployed and mission critical pers.Homeland and national security Less severeModerateSevereEst. numberTarget groupCategory Target groups for pandemic vaccination by pandemic severity Tier 1 Tier 2 Tier 3 Tier 4 Tier 5 Not targeted

20. Vaccination tiers for a severe pandemic Vaccination tiers 23 million 17 million 64 million 74 million 122 million 300 M Tier 1 Tier 2 Tier 3 Tier 4 Tier 5 Rest of population High risk population - High risk adults - Elderly Critical occupations - Deployed forces - Critical healthcare - EMS - Fire - Police - Govt. leaders High risk population - Pregnant women - Infants - Toddlers Critical occupations - Military support - Border protection - National Guard - Intelligence serv. - Other natl. security - Community serv. - Utilities - Communications - Critical govt. High risk population - Infant contacts - High risk children Critical occupations - Other active duty - Other healthcare - Other CI sectors - Other govt. High risk population - Healthy children

21. Next steps: vetting the draft guidance with the public and stakeholders 2 month comment period –Request for comments in the Federal Register and HHS website (www.pandemicflu.gov) –Presentations to ACIP and NVAC –Public & stakeholder meetings –Web based public engagement Additional tasks –Validate population estimates –Consider options for implementation When completed, the guidance will be “final interim”