Draft Guidance on Prioritization of Pandemic

Influenza Vaccine

Draft Guidance on Prioritization of Pandemic

Influenza Vaccine

Who should get vaccinations first?

Benjamin Schwartz, M.D.National Vaccine Program Office, DHHS

• Why prioritize pandemic influenza vaccinations?

• 2005 ACIP/NVAC process and recommendations

• Current prioritization process and draft guidance

• Next steps

Issues to addressIssues 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?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

“Preparedness now decreases the need forallocation decisions later”

Kathy Kinlaw, MDiv, Emory Univ.CDC Ethics Subcommittee

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

Pandemic vaccine prioritization 2005: Pandemic vaccine prioritization 2005: ACIP/NVACACIP/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

ACIP/NVAC priority groupsACIP/NVAC priority groups

Personnel CumulativeTier 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

Rationale for reconsideration of Rationale for reconsideration of pandemic vaccine prioritizationpandemic 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

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 6.1.14.2http://www.whitehouse.gov/homeland/nspi_implementation_chap06.pdf

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 notice

Ethics Considerations by the Ethics Considerations by the Interagency Working GroupInteragency 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

National Infrastructure Advisory Council National Infrastructure Advisory Council analysis of critical infrastructure (CI) for a analysis of critical infrastructure (CI) for a

U.S. pandemicU.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

Identifying critical employee Identifying critical employee groups: all sectors, tier 1 onlygroups: 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: 161,309Commercial Facilities: 42,000Communications: 396,097Electricity: 50,000 Emergency Services: 1,997,583 Food and Agriculture: 500,000Healthcare: 6,999,725Information Technology: 692,800Nuclear: 86,000Oil and Natural Gas: 223,934Postal and Shipping: 115,344Transportation: 100,185Water and Wastewater: 608,000

TOTAL: 12,389,977

Tier 1 Statistics Banking & Finance

Chemical

Commercial Facilities

Communications

Electricity

Emergency Services

Food and Agriculture

Healthcare

Information Technology

Nuclear

Oil and Natural Gas

Postal and Shipping

Transportation

Water and Wastewater

Tier 1 Statistics Banking & Finance

Chemical

Commercial Facilities

Communications

Electricity

Emergency Services

Food and Agriculture

Healthcare

Information Technology

Nuclear

Oil and Natural Gas

Postal and Shipping

Transportation

Water and Wastewater

http://www.dhs.gov/xlibrary/assets/niac/niac-pandemic-wg_v8-011707.pdf

• 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: publicValue of pandemic vaccination goals: public(Las Cruces, Nassau Co.) and stakeholder (DC) (Las Cruces, Nassau Co.) and stakeholder (DC)

meeting results (7-point scale)meeting results (7-point scale)

Vaccination goal: To protect…Las

CrucesNassau County

D.C.

People working to fight pandemic & provide care 6.7 6.0 6.8

People providing essential community services 5.9 5.7 6.5

People most vulnerable due to jobs 5.8 5.6 5.9

Children 5.9 5.7 4.9

People most likely to spread virus to unprotected 5.3 5.3 4.6

People protecting homeland security 4.6 5.2 4.7

People most likely to get sick or die 4.5 4.8 4.8

People most likely to be protected by the vaccine 4.5 5.1 4.0

People keeping pandemic out of the U.S. 4.3 5.3 3.3

People providing essential economic services 3.0 4.2 4.5

Decision analysisDecision 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

Structure of the draft guidanceStructure 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

Vaccination tiers for a severe pandemicVaccination 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

4,300,0006,500,000

Household contacts of infants < 6 moChildren 3–18 yrs with high risk cond.

3,100,00010,300,000

Pregnant womenInfants & 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 personnelOther important govt. personnel

1,900,000 to 4,400,000

Electricity, Natural gas, Communications, Water personnelCritical government personnel

2,000,000

50,00050,000

Emergency Medical Service, Law enforcement, Fire services personnelMfrs of pandemic vaccine & antiviralsKey government leaders

Critical infrastructure

500,000Other important health care personnel

600,000Community suppt. & emergency mgt.

300,0003,200,0002,000,000

800,000

Public health personnelInpatient health care providersOutpatient and home health providersHealth care providers in LTCFs

Health care and community support services

1,500,000Other active duty & essential suppt.

650,000150,000100,000500,000

50,000

Essential support & sustainment pers.Intelligence servicesBorder protection personnelNational Guard personnelOther domestic national security pers.

700,000Deployed and mission critical pers.Homeland and national security

Less severeModerateSevereEst. numberTarget groupCategory

Target groupsfor pandemicvaccinationby pandemicseverity

Tier 1Tier 2Tier 3Tier 4Tier 5Not targeted

Vaccination tiers for a severe pandemicVaccination 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. leadersHigh 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

Next steps: vetting the draft guidance with Next steps: vetting the draft guidance with the public and stakeholdersthe 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”