Summary of June 15-16, 2005 Meeting of Joint ACIP/NVAC Working Group on Pandemic Influenza Vaccine Prioritization Co-chairs Ban Allos and Gary Freed NVAC and ACIP Joint Meeting Washington, D.C. July 19, 2005

Goals of Working Group Meeting Review information on pandemic influenza impact Develop draft list of groups for prioritized for pandemic influenza vaccine and presentation to ACIP and NVAC  Consider sub-prioritization

Timeline and Process April 20, st working group meeting Inter-meeting working groups  Prior pandemics  Healthcare workers  Essential Services  Ethics June nd working group meeting June 22 – conference call with NVAC Pandemic Influenza Working Group June 30  Presentation to ACIP and sent to NVAC Comments received through July 11

Overall Goals for Pandemic Planning To minimize hospitalizations and deaths To preserve critical infrastructure and minimize social disruption Overall, vaccine and antiviral working groups felt goals should be rank ordered  Acknowledged that both goals tightly linked

Overall Goals for Pandemic Influenza Vaccination Program To vaccinate all persons in U.S. who desire vaccination In the likely event of a shortage given current vaccine manufacturing capacity, prioritize vaccine:  To minimize hospitalizations and deaths  To preserve critical infrastructure and minimize social disruption

Key Assumptions I Health impact of a pandemic  25-30% (range in working age 20-30% most likely) of persons may become ill in major wave  Outbreak period in a community 6-8 weeks per wave with possibly >1 wave in a community  Rates of influenza-related hospitalizations and deaths may vary substantially based on 1918, 1957, and1968 pandemics depending on age and risk group 0.01%-8% persons may be hospitalized 0.001–1% ill persons may die  Medical care services severely taxed or overwhelmed

Key Assumptions II Health impact of a pandemic  Illness duration preventing work for uncomplicated case influenza: 5 days  10% or more workers out of work at the peak of a major wave Includes work loss caring for self or for ill family member  Assumes 8 week outbreak period and 25% overall attack rate

Key Assumptions III Vaccine production and use  Time from candidate vaccine strain to first doses >6 months  Current optimistic U.S. production capacity for inactivated vaccine 5 M doses per week  Current capacity for live attenuated vaccine production 1.5 million doses per week Bulk material made in the U.K., not in U.S.  2 doses per person likely needed for immune response  Dept of Defense high priority for vaccination 0.5 M-1.5 M persons Limited supply antiviral medications Thus, need for rationale, explicit prioritization of vaccine However, any prioritization scheme will likely require modification based on epidemiology of a new pandemic

Key Assumptions IV Critical Infrastructure  Considered groups or subgroups who Direct role in reducing hospitalizations and deaths Role in preventing social disruption Likely to experience increased demand during pandemic  Little information available to assess potential impact of pandemic influenza on non-healthcare and non- military sectors Information from prior pandemics difficult to apply now due to changes in business practices  More work with CI groups need to identify groups and sub-groups most in need of vaccination and/or antivirals

Main Vaccine Prioritization Considerations Impact of past pandemics (and inter-pandemic influenza) by age and risk group on hospitalization and death Likelihood of response to vaccination Directness of role in preventing hospitalizations and deaths and preventing social disruption Current U.S. inactivated vaccine manufacturing capacity Lessons learned from influenza vaccine shortage

Pandemic vaccination program progress toward meeting 80% goal for target groups, assuming 5 million doses per week (HR 88.3M; ~HCW 9M; ~CI 8.9M; children 5-17 yr 53.2M; children 6m-17yr 69.3M) No. doses for immunity Vaccinated Population (cumulative millions) High Risk Only HCW Only Pandemic begins ???? High Risk + HCW Critical Infrastructure Only

Draft Key Conclusions “Maximize preparedness to minimize allocation needs”, Kathy Kinlaw In order to reduce need for rationing, working group strongly expressed that investment needed to:  Expand U.S. vaccine manufacturing capacity  Conduct research to Extend existing vaccine supply Improve efficiency in vaccine production Develop new vaccines with improved effectiveness and ease of manufacturing  Develop and test seed lots vaccine with pandemic potential  Improve interpandemic vaccine delivery infrastructure, e.g. adult vaccination program  Consider stockpiling monovalent vaccine strain(s) with greatest pandemic potential

Other Draft Key Conclusions II Initiate and plan for use of LAIV along with inactivated vaccine Concurrent with efforts to minimize vaccine shortfalls, further enhance antiviral medication stockpile Given range of impact of pandemics, revisit recommendations on regular basis before and during a pandemic  Revise as appropriate Reserve some vaccine for vaccination of workers critical to response to unforeseen emergencies Obtain public input on vaccine prioritization Develop pre-pandemic public & providers communication tools

Draft Priority Groups PersonnelCumulative Element and Tier ( 1,000’s) total (1,000’s) 1A. Health care involved in direct patient 9,000 9,000 contact + essential support Vaccine and antivirals manufacturing 40 9,040 personnel 1B. Highest risk group 25,840 34,880 1C. Household contacts children <6 months and 10,700 45,580 Severely immune compromised, and pregnant women 1D. Key government leaders +critical public ,731 health pandemic responders 2. Rest of high risk 59, ,831 Most CI and other PH emergency responders 8, , Other key government health decision ,831 makers + mortuary services 4. Healthy 2-64 years not in other groups 179, ,091

Definitions 1A. Healthcare workers - those with direct patient contact plus critical healthcare support staff  Includes inpatient, outpatient, home care, EMS, blood collection, supporting laboratories, vaccinators and public health providers with direct patient contact plus their critical support personnel

Definitions 1B. Highest risk group  >64 with 1+ high risk conditions  6m-64y with 2+ high risk conditions  Hospitalization in prior year with pneumonia or influenza or an ACIP high risk condition 1C. Household contacts of children <6m or severely immune compromised 1C. Pregnant women in any stage of pregnancy 1D. Key government leaders and critical pandemic public health responders

Definitions 2.  Other high risk >65 years with no high risk conditions 6 months-64 years with 1 high risk condition 6-23 month olds  Critical infrastructure groups Other public health emergency responders Public safety (fire, police, 911 dispatchers, correctional facility staff) Utility workers essential for maintaining functional of power, water, and sewage systems Transportation workers critical for transportation fuel, food, water, and medical supplies and for public ground transportation Telecommunications/IT personnel essential for maintaining functional communication and network operations

Definitions 3.  Other key government health care decision makers  Mortuary services 4. Healthy persons 2-64 years not included in above categories

Other Opinions on Tiering No subtiering – keep as simple as possible Collapse groups 1C and 1D since 1D group small Move key government leaders to tier 1A Move critical public health responders to tier 1A Subtier group 2 into groups (2A and 2B), putting high risk patients first then CI groups Combine tier 3 with tier 2b Delete tier 3 Differences with Canadian pandemic plan tiering May require re-ordering if severe illness rates in yo = 64 yo

Canadian Pandemic Plan Priority Groups Applicable Category Group 1 Health care workers, paramedics/ambulance attendants and public health workers Front-line Health Care Provider Essential Health Care Provider Public Health Responder Essential Health Support Services Key Health Decision Maker Group 2Essential service providers Pandemic Societal Responder Key Societal Decision Makers Group 3 Persons at high risk of fatal outcomes A.Nursing home residents B.Any age with high risk conditions C.Healthy >65 years D.6-23 months E.Pregnant women Group 4Healthy adultsN/A Group 5Healthy children 2-18 yrsN/A

Groups for whom antiviral strategy may be considered Nursing homes with 24-hour skilled nursing care  Rationale Less likely to mount a protective immune response compared with other high risk groups Semi-closed populations with medical director Vaccination of healthcare workers and critical support staff would be high priority Need for prioritization in setting of severe vaccine shortage and severe impact in overall U.S. population  Draft recommendation High vaccination rates of staff Limit ill staff and visitors Close monitoring for respiratory outbreaks Aggressive use of antivirals among nursing home residents for outbreak control

Antiviral strategy, continued Severely immune compromised persons who are not likely to respond to vaccination  Rationale Persons severely immune compromised unlikely to develop protective immune response (e.g. children with SCID, recent BMT, etc.)  Recommendation High vaccination rates of healthcare workers who work closely with these groups Vaccination of household contacts Close monitoring for respiratory illness Aggressive use of antivirals for treatment of severely immune compromised Consider antiviral prophylaxis

Summary Strong consensus for strengthening vaccine supply in inter-pandemic period to minimize need for prioritization If prioritization needed  Healthcare workers  Highest risk who can be vaccinated  Household contacts of highest risk who won’t respond to vaccine  Rest of high risk and most critical infrastructure  Rest of persons 2-64 years Prioritization will need to be updated as additional information is known

Thank you to the working group participants and coordinators

Draft Priority Groups PersonnelCumulative Element and Tier ( 1,000’s) total (1,000’s) 1A. Health care involved in direct patient 9,000 9,000 contact + essential support Vaccine and antivirals manufacturing 40 9,040 personnel 1B. Highest risk group 25,840 34,880 1C. Household contacts children <6 months and 10,700 45,580 Severely immune compromised, and pregnant women 1D. Key government leaders +critical public ,731 health pandemic responders 2. Rest of high risk 59, ,831 Most CI and other PH emergency responders 8, , Other key government health decision ,831 makers + mortuary services 4. Healthy 2-64 years not in other groups 179, ,091

Other Opinions on Tiering No subtiering – keep as simple as possible Collapse groups 1C and 1D since 1D group small Move key government leaders to tier 1A Move critical public health responders to tier 1A Subtier group 2 into groups 2A and 2B, putting high risk patients first then CI groups Combine tier 3 with tier 2b Delete tier 3

Canadian Pandemic Plan Priority Groups Applicable Category Group 1 Health care workers, paramedics/ambulance attendants and public health workers Front-line Health Care Provider Essential Health Care Provider Public Health Responder Essential Health Support Services Key Health Decision Maker Group 2Essential service providers Pandemic Societal Responder Key Societal Decision Makers Group 3 Persons at high risk of fatal outcomes A.Nursing home residents B.Any age with high risk conditions C.Healthy >65 years D.6-23 months E.Pregnant women Group 4Healthy adultsN/A Group 5Healthy children 2-18 yrsN/A

Deaths per 100,000 in selected age groups <1 yr25-44 yr>64 yr *240 <1 yr25-44 yr>64 yr HR 1968*NA non-HR HR Inter- pandemic **NA230*** Non-HR IP *0-4 yrs 1900 for HR, 530 non-HR **<6 months olds 900 ***Up to 8600 for elderly with both heart and lung disease Hospitalizations per 100,000 in selected age groups *Death rate as high as 870 in very high risk group, e.g. elderly with both lung and heart disease

Estimate of Days Lost From Work Due to Illness in Self or Family Xinzhi Zhang, MD PhD and Martin I. Meltzer, PhD MS Modeled lost work days from illness using FluAid and FluSurge and 2000 Census Inputs:  Days lost from work due to illness by different triage (death, hospitalization, outpatient, self-cured) and age group  Days lost from work due to caring for family member by different triage and age group  Other assumptions employment rate, marriage rate, work days per month Assumed outbreak period 8 weeks and 25% influenza illness rate as base-case

Model Inputs and Total Lost Days Scenario Self- care OutpatientHosp.Death Self- care OutpatientHosp.Death A B Days of work for own illnessDays caring for others Work Days LostScenario AScenario B Most Likely 130,672,484269,845,189 Minimum 110,435,229249,341,669 Maximum 161,643,371300,682,747

Scenario B (10%) Scenario A (4.8%)

Limitations Assumptions of work day loss for caring and illness fall into a large range  Largely unknown from literature  For interpandemic influenza, lost work days per illness-like illness average 1 day in US studies Assumptions of distribution of days lost from work may not reflect the real situation (e.g. community, enterprise etc.) Meeting subject matter experts felt that peak would be sharper than in the model, particularly for smaller communities

Reference Meltzer MI, Cox NJ, Fukuda K. The economic impact of pandemic influenza in the United States: implications for setting priorities for intervention. Emerg Infect Dis 1999;5: Available on the Web at: Meltzer MI, Cox NJ, Fukuda K. Modeling the economic impact of pandemic influenza in the United States: implications for setting priorities for intervention. Background paper; Available on the Web at: Meltzer MI, Shoemake H, Kownaski M. FluAid 2.0: a manual to aid state and local- level public health officials plan, prepare, and practice for the next influenza pandemic. Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; Zhang X, Meltzer MI, Wortley P. FluSurge2.0: a manual to assist state and local public health officials and hospital administrators in estimating the impact of an influenza pandemic on hospital surge capacity (Beta test version). Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; 2005.