# Presentation: 528255

## Draft Guidance on Prioritization of Pandemic Influenza Vaccine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Current prioritization process and draft guidance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

- 2005 ACIP/NVAC process and recommendations
- Current prioritization process and draft guidance
- Next steps

- 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

- 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

- “Preparedness now decreases the need for
- allocation 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: 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

## 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****	**

## 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

## 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

## 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](http://www.pandemicflu.gov/)__ notice _

## 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

## 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

## Identifying critical employee groups: all sectors, tier 1 only

- Notes:
*Numbers include Tier 1 “essential” employees only.*
*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

## 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

- 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 | 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 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 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 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

## Target groups

- 500,000

- Other important health care personnel

- 600,000

- Community 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**

- 1,500,000

- Other 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.

- 700,000

- Deployed and mission critical pers.

**Homeland and national security**

**Less severe**

**Moderate**

**Severe**

**Est. number**

**Target group**

**Category**

**Target groups**
**for pandemic**
**vaccination**
**by pandemic**
**severity**

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

## 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

## 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”