Draft Guidance on Prioritization of Pandemic Influenza Vaccine Who should get vaccinations first?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

Background Why prioritize pandemic influenza vaccinations? 2005 ACIP/NVAC process and recommendations Proposed prioritization strategy Process Draft guidance Results of vetting process Implementation Issues to address

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?

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 How soon vaccine is available relative to community outbreaks and how much vaccine will be available are unknown

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 –Ethical concerns Recommendations included in the 2005 HHS pandemic plan –As guidance for State/local planning –To promote further discussions

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 ,731 health pandemic responders 2. Rest of high risk 59,100104,831 Most CI and other PH emergency responders 8,500113, Other key government health decision ,831 makers + mortuary services 4. Healthy 2-64 years not in other groups 179,260293,091

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 & 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 noticewww.pandemicflu.gov

National Infrastructure Advisory Council: Essential Workers, Tier 1 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

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

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 care People providing essential community services People most vulnerable due to jobs Children People most likely to spread virus to unprotected People protecting homeland security People most likely to get sick or die People most likely to be protected by the vaccine People keeping pandemic out of the U.S People providing essential economic services

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

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 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 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 Proposed target groups for pandemic vaccination by pandemic severity Tier 1 Tier 2 Tier 3 Tier 4 Tier 5 Not targeted

Vetting the draft guidance with the public and stakeholders Presentations to ACIP and NVAC Public meetings (Milwaukee, WI; Hendersonville, NC) Stakeholders meeting (Washington, DC) Web-dialogue Request for comments in the Federal Register and HHS website (

Suggestions from the vetting process Strong support expressed –Goals and values underlying the plan –Prioritization of children before older adults –Structure of the guidance Specific suggestions for changes –Target pharmacists and mortuary services (Tier 2) –Target financial clearing and settlement (Tier 2) –Move government leaders who don’t have high risk contacts to their general population group –Prioritize healthy adults before ill and elderly

Implementation (1) Most vaccine to be allocated & distributed to States States are strongly encouraged to follow national guidance –Different State plans would cause confusion, complicate communication, and interfere with efforts to protect essential services –Prioritization guidance provides States with some flexibility to address local needs Guidance on implementation being developed by an interagency working group co-led by CDC and DHS

Implementation (2) State/local planning –Receipt and distribution of vaccine –Strategy for vaccination of the general population –Monitoring Federal roles –DOD will vaccinate military personnel –Federal employees may be vaccinated at VA facilities –Vaccine safety monitoring Vaccination of critical infrastructure workers –Strategy to identify, validate, vaccinate & monitor TBD