Update on Pandemic Influenza Response Strategies

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Update on Pandemic Influenza Response Strategies
Ben Schwartz, M.D. National Vaccine Program
Office, DHHS
2
Issues to address Whats new in national
planning?

• Community mitigation guidance and the pandemic
  severity index (PSI)
• Pandemic vaccine prioritization
• Antiviral drug strategies

3
Public health and community mitigation strategies
1

• Objectives
• 1 - delay outbreak
• 2 - diminish peakburden
• 3 - decrease overallillness rate
• Strategies
• Personal hygiene handwashing cough etiquette
• Social distancing
• Community-based interventions

Daily Cases
Unmitigated outbreak
2
Mitigated outbreak
3
Days since first case
4
Community-Based Interventions Targeted Layered
Containment

• Interventions targeted to commonsettings of
  disease transmission(households, schools,
  workplaces,and communities)
• Components
• Isolate cases voluntary quarantineof case
  households
• Close schools keep children home
• Cancel public gatherings
• Social distancing in communities and at
  workplaces
• Federal guidance posted at www.pandemicflu.gov

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Pandemic influenza mortality A tale of two
cities, 1918
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Modeled Impacts of Community Mitigation on
Pandemic Mortality
NPI Non-pharmaceutical Intervention Rx
treatment PEP post-exposure prophylaxis
U.S. national planning assumptions for pandemic
severity intervention at 1 community attack
rate 60 case ascertainment and
treatment/household prophylaxis 30 compliance
with voluntary quarantine 25 effectiveness of
antiviral Rx to prevent death modeling by N.
Ferguson, Imperial Col, London
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Critical success factors for community mitigation

• Timing
• Interventions need to be implemented early before
  infection is widespread (lt1 of population ill)
• Compliance (modeling estimates)
• Keeping kids from re-congregating when dismissed
  from school (30 90)
• Case isolation and voluntary household quarantine
  (30 90)
• Reducing contacts in workplaces and communities
  (50)
• Ability to mitigate adverse secondary
  consequences
• E.g., work loss from closing schools impacts on
  school lunch program, etc.

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Pandemic Severity Index

• Defines severity based on case fatality rate
• Isolation and case treatment recommended at all
  PSI
• Other interventionsbased on PSI
• PSI 5/4 recommend
• PSI 3/2 consider
• PSI 1 generally not recommend

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Availability and prioritization of pandemic
vaccine
10
Pandemic vaccine supply

• Pandemic vaccine first available at 20 weeks
  after identification of the pandemic virus
• Monthly increments depend on production capacity
  and ability to decrease antigen content by use of
  adjuvants to stimulate immunity

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Interagency pandemic vaccine prioritization
working group

• Participants from federal agencies
• Process included
• Presentation and discussion of ethical issues
• Presentations on key issues and by key
  stakeholders
• Consideration of ACIP/NVAC recommendations
• Consideration of National Infrastructure Advisory
  Council recommendations on critical
  infrastructure
• Public engagement meetings
• Stakeholder meeting
• Decision analysis process
• Written comments

12
NIAC analysis of critical infrastructure (CI) for
a U.S. pandemic

• Request for analysis from Secs. Leavitt
  Chertoff
• Issues considered
• Critical functions of CI and key resource (KR)
  sectors (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
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Identifying critical employee groups Sector
detail all sectors, all tiers
Critical Employees Tiers 1 -3 Banking Finance
1,562,000 Chemical 322,618 Commercial
Facilities 84,000 Communications
796,194 Electricity 375,000 Emergency Services
1,997,583 Food and Agriculture
750,000 Healthcare 6,999,725 Information
Technology 2,358,800 Nuclear 86,000 Oil and
Natural Gas 328,674 Postal and Shipping
464,744 Transportation 198,387 Water and
Wastewater 608,000 TOTAL 16,931,725

• Notes
• Numbers include Tier 1, Tier 2, and Tier 3
  essential employees.
• State and local government numbers removed from
  gross and priority workforce numbers.

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Public engagement and stakeholder meetings

• Objective Consider goals of pandemic vaccination
  and assign values to each
• Approach
• Background presentations
• Group discussions
• Electronic voting (rating of goals on 7-point
  scale)
• Participants
• Las Cruces NM 108 persons culturally diverse
• Nassau Co., NY 130 persons many older persons
• DC 90 persons government, CI sectors,
  community organizations

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Value of pandemic vaccination goals public(Las
Cruces, Nassau Co.) and stakeholder (DC) meeting
results (7-point scale)
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Key outcomes of public engagement and stakeholder
meetings

• Consistency in most highly rated goals
• Values underlying those goals were
• Maintaining critical societal functions
• Protecting those who would help others during the
  pandemic
• Protecting children as our future
• Key messages
• Balance vaccine use to achieve multiple pandemic
  response goals
• Consider multiple factors in defining higher
  priority groups

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Next steps

• Public announcement of draft guidance
• Obtain comments and finalize prioritization
  guidance
• Stakeholder meetings
• Public engagement meetings
• Web-based public engagement
• Written comments (Federal Register
  pandemicflu.gov)
• Advisory committee input (ACIP, NVAC NIAC)

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Antiviral drugs and potential expansion of
prophylaxis strategies
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Current antiviral drug use strategies and
stockpiling

• Primary strategy is early treatment
• Meets expectations of clinicians and patients
• Effective in reducing duration and severity of
  illness
• Stockpiling
• Target of 81 M regimens
• 75 M treatment 6 M quenching international and
  domestic outbreaks
• Federal purchase of 50 M and State purchase of 31
  M regimens with federal cost share
• In early 2007, about 50 M regimens in hand or
  ordered
• DOD, VA, and private sectors also stockpiling

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Reassessment of antiviral drug use strategies
stockpile targets

• Allowed by increased production of antiviral
  drugs
• Possible need for prophylaxis to maintain health
  care and other critical infrastructures
• MD health dept survey only 54 indicated they
  would report to work in a pandemic
• Community mitigation guidance suggests value of
  household post-exposure prophylaxis (PEP)

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Interagency working group on antiviral prophylaxis

• Representatives from federal agencies, State
  local public health (ASTHO, NACCHO), IHS
• Objective to develop guidance on antiviral
  prophylaxis for policy consideration
• Consider prophylaxis strategies target groups
  by antiviral drug availability
• lt 75 M regimens retain focus on treatment
• No limit on supply

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Potential impacts of household post-exposure
prophylaxis (PEP)
1.8 M

• Impact on illness and death may be
  substantial
• May improve compliance with other
  mitigation strategies
• Caveats
• Estimates are based on models and assumptions
• Assumption of 60 cases treated and 100 of
  family members prophylaxed at 24 hrs not
  currently feasible

Deaths (thousands)
.5 M
.35 M
.24 M
U.S. national planning assumptions for pandemic
severity intervention at 1 community attack
rate 60 case ascertainment and
treatment/household prophylaxis 30 compliance
with voluntary quarantine 25 effectiveness of
antiviral Rx to prevent death modeling by N.
Ferguson, Imperial Col, London
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Potential barriers to effectively implementing
household PEP

• Case detection and diagnosis
• Proportion and timing of cases presenting to HCW
• Diagnostic strategy
• POC testing not sensitive withhold Rx for a
  negative test?
• ILI diagnosis has a low PPV lt35 for annual
  influenza
• Dispensing antiviral medications
• Capacity and timeliness
• Pharmacy practice guidelines
• Validation
• Education and compliance

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Other potential settings and strategies for
antiviral prophylaxis
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Implementation Issues for Workplace PEP

• Target groups
• E.g., all HCWs or CI workers or only critical
  workers?
• PEP process
• Timeliness of case detection
• Need for investigation
• Definition of exposed contacts
• Approach to antiviral drug dispensing
• Role of health department vs occupational health
• Estimated burden and antiviral drug requirement
• Base on mitigated or unmitigated pandemic?

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Conclusions implications of new developments in
pandemic response planning

• Plan implementation of community mitigation
• Surveillance and triggers plans and materials
  for effective implementation mitigation of
  adverse consequences
• Consider implications on planning of increased
  countermeasure supply and possible new strategies
• Comments on strategies being considered are
  welcomed
• Stay informed as policies are finalized
• Work with partners to begin planning
  implementation

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ESF 8 Pandemic Influenza Planning

• Casey Wright, ScM
• Office of the Assistant Secretary for
  Preparedness and Response
• U.S. Department of Health and Human Services

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Outline

• Goals, strategies and framework for ESF 8
  response
• Response missions, structure and ESF 8 op tempo

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Goals for Managing a Pandemic
1. Delay disease transmission and outbreak
peak 2. Decompress peak burden on healthcare
infrastructure 3. Diminish overall cases and
health impacts
1
Pandemic outbreak No intervention
2
Daily Cases
Pandemic outbreak With intervention
3
Days since First Case
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HHS Missions at Stages 0 and 1

• Stage 0
• Ensure effective surveillance and reporting
  systems
• Support antiviral and vaccine development and
  stockpiling
• Assist State, local and Tribal and international
  partners in public health and medical response
  planning
• Stage 1
• Rapidly confirm or refute reports of efficient
  h2h2h transmission
• Initiation of ESF 8 coordination mechanisms and
  logistical support

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ESF 8 Missions at Stages 2 and 3

• International Containment
• Deployment of a Rapid Response Team
• Deploy SNS to 62 project areas in phases
• Deploy ESF 8 personnel to support screening,
  quarantine and isolation operations at aviation,
  land and maritime ports of entry
• Activate EMG and deploy SHOs and IRCTs to JFOs

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Regionally-Based JFO Areas of Responsibility
National SHO Dr. Kevin Yeskey
C
C SHO CAPT James Galloway
AK
ND
WA
MT
MN
ME
WI
SD
VT
OR
ID
NH
NY
WY
MI
MA
NE
IA
CT
RI
PA
OH
E
IL
NJ
A
IN
NV
MD
UT
KS
DE
CO
WV
E SHO RADM Patrick
OCarroll
DC
KY
CA
MO
VA
A SHO Dr. Pierre Noel
TN
NC
OK
NM
AZ
MS
SC
AR
AL
GA
TX
B
LA
B SHO CAPT Ali Khan
FL
D
D SHO RADM Ron Banks
REGION A Standard Federal Regions 12
(Boston/New York)
PR
VI
REGION B Standard Federal Regions 34
(Philadelphia/Atlanta)
REGION C Standard Federal Regions 58
(Chicago/Denver)
REGION D Standard Federal Regions 67
(Denton/Kansas City)
REGION E Standard Federal Regions 910
(Oakland/Bothell)
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ESF 8 Pandemic Influenza Response Incident
Command Structure
Secretary
ASPR with EMG
Headquarters Level Activated at Stage
2 - 6
Op Divs Leadership (ACF, AoA, AHRQ, ATSDR, CDC,
CMS, FDA, HRSA, IHS, NIH, SAMHSA)
Staff Divs Leadership (IOS, ASAM, ASBTF, ASH,
ASL, ASPE, OSGASPA, OD, DAB, OCR, OIG, OMHA,
IGA, OGC)
--------------------------------------------------
--------------------------------------------------
--------------------------------------------------
--------------
5 FEMA PI Regions Activated at Stage 2 - 6
ESF 6 (Human Services)
--------------------------------------------------
--------------------------------------------------
--------------------------------------------------
--------------
State Level Activated at Stage 2 - 6
Information and Intelligence Sharing
HHS Senior Medical Officer
HHS Senior Medical Officer
HHS/CDC SMO or other ESF 8 LNO
HHS/CDC SMO or other ESF 8 LNO
HHS/CDC SMO or other ESF 8 LNO
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ESF 8 Missions at Stage 4

• Deploy ESF 8 personnel to support domestic
  containment in first affected communities
• Attempt to delay progression with vigorous
  response to earliest cases
• Technical advice on implementation of community
  mitigation strategies
• Maintain ESF 8 presence at points of entry

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ESF 8 Missions at Stages 5 and 6

• Pull back majority of ESF 8 resources to support
  HHS business continuity
• Secondary priorities include
• Support to Federal healthcare infrastructures
• Support to other critical infrastructures
• Shift in focus the new C2 is Communication and
  Coordination with States, tribes and territories

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Get Informed. Be Prepared

• One-stop access to avian and pandemic flu
  information from the U.S. Government
• Managed by the
• U.S. Department of Health and Human Services

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National Disaster Medical System

• Current NDMS PI Overview

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Briefing Overview

• National Disaster Medical System
• Alignment within HHS
• Background and Origins
• Structure and Components
• Capabilities
• NDMS Role in ESF8
• Recent Deployments
• 2004 Florida Hurricanes
• 2005 Gulf Coast Hurricanes

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NDMS in the HHS Organization
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HHS Regional Offices
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NDMS Background Origins

• National Security Decision Directive 47 (NSDD-47)
  
• Approved by the President (July, 1982)
• Set forth Emergency Mobilization
• Preparedness Principles for
• National Security Emergencies
• Domestic Emergencies

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NSDD-47
Health
It is the policy of the United States to develop
systems and plans to ensure that sufficient
medical personnel, supplies, equipment, and
facilities will be available and deployed to meet
essential civilian and military health care needs
in an emergency.
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National Disaster Medical System
A public / private sector partnership HHS DHS
DOD VA

• A Nationwide Medical Response System to
• Supplement state and local medical resources
  during disasters or major emergencies
• Provide backup medical support to the military/
  VA medical care systems during an overseas
  conventional conflict

45
National Disaster Medical System
Major Components of NDMS
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NDMS

3 Major Components of NDMS
Medical Response Lead HHS
Patient Evacuation Lead DoD
Definitive Care Lead DoD/VA
DoD Aeromedical Evacuation Primarily Fixed Wing
DoD/VA Federal Coordinating Centers
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NDMS Medical Response
Lead Responsibility - HHS

• Assist in Assessment of Health/Medical Needs
• Provision of On-Scene Medical Services
• Victim Identification/Mortuary Services
• Veterinary Medical Services

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NDMS Medical Response
Lead Responsibility - HHS

• More than 9,000 personnel in the
• System
• Equipment and Supplies
• Medical Team Caches
• Veterinary Medical Assistance Team
• Cache
• Deployable Portable Morgue Units
• Mobile Intensive Care Units

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NDMS Medical Response
Disaster Medical Assistance Teams
Disaster Medical Assistance Teams

• Groups of Intermittent Federal Employees who
  Volunteer to be on Designated Team for NDMS
• Approximately 35 Persons per Team (deployed)
• (gt 5,700 personnel currently enrolled in
  DMATs)
• Variety of Health/Medical Skills
• NDMS Teams are Sponsored by the U.S. Government
• Team Originate from Community-Based Health
  Medical Organization

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DMAT Functions
At Disaster Site

• Triage
• Primary Medical Care
• Casualty Clearing/Staging

At Local NDMS Reception Area

• Patient Reception

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NDMS Specialty Teams

• Pediatric
• Burn
• Disaster Mortuary Operational Response Teams
  (DMORTs)
• Urban Search and Rescue Medical Team
• Mental Health
• Veterinary Medical Assistance Teams (VMATs)
• National Medical Response Teams (NMRTs)
• Medical Surgical Response Teams (MSuRTs)

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DMAT and Specialty Teams

• Members are Intermittent Federal Employees
• (Public Law 107-188)

• Importance of Federalization
• Licensure / Certification
• Liability
• Compensation
• USERRA Coverage

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NDMS Response Teams

• 35 Disaster Medical Assistance Teams - (Fully
  Operational/Operational)
• 17 Disaster Medical Assistance Teams -
  (Augmentation/Developmental)
• 4 National Medical Response Teams / WMD
• 4 Burn Teams
• 2 Pediatric Teams
• 1 Crush Medicine Team
• 3 International Medical / Surgical Teams
• 2 Mental Health Teams
• 4 Veterinary Medical Assistance Teams
• Disaster Mortuary Operational Response Teams (1
  WMD)
• National Pharmacist Response Teams
• 10 National Nurse Response Teams
• 1 Management Support Team(s)
• 
  

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Roles of Emergency Support Function 8

• 1. Assessment of Public Health and Medical Needs
  
• 2. Health Surveillance
• 3. Medical Care Personnel
• 4. Health/Medical Equipment and Supplies
• 5. Patient Evacuation
• 6. In-Hospital/Patient Care
• 7. Safety and Security of Human Drugs,
  Biologics, Medical Devices, and Veterinary
  Drugs
• 8. Blood and Blood Products
• 9. Food Safety and Security
• 10. Agriculture Safety and Security
• 11. Worker Health/Safety
• 12. All-Hazard Public Health and Medical
  Consultation, Technical Assistance,
• and Support
• 13. Behavioral Health Care
• 14. Public Health and Medical Information
• 15. Vector Control
• 16. Potable Water/Wastewater Solid Waste
  Disposal
• 17. Victim Identification/Mortuary Services
  
• 18. Protection of Animal Health
  NDMS supported

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Patient Evacuation
Lead Responsibility - DOD

• Provide Patient Movement from the Disaster Area
• Utilize All Types of Transportation
• Primarily Relies on Aeromedical

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Patient Movement

• Coordinated inter-agency process
• Identification of a need to move a patient
• Admission of a patient at a destination
• medical facility

63
NDMS Roles

• Patient Stabilization
• Staffing of Regional EVAC Points (REP)
• Staffing of Patient Reception Areas (PRA)
• Patient Preparation
• Patient Regulation

64
Additional Transport Providers

• ESF-8 Partners
• Department of Transportation
• General Services Administration
• U.S. Postal Service
• American Red Cross
• Private Contractors

65
DOD Role

• Support agency to ESF 8, Public Health and
  Medical Services
• 1. Coordinate Patient Movement - DoD is lead for
  patient movement in collaboration with other
  federal agencies. Responsible for movement of
  patients on DoD resources.
• Provides transportation assets, medical crews,
  patient regulating teams
• Transportation medical assets include
• Aero-medical Evacuation Kits
• Patient Movement Equipment
• Civilian Reserve Air Fleet in Homeland Incident

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DOD Role (cont)

• Coordinate Patient Movement (Cont)
• Global Patient Movement Requirements Center
  (GPMRC) located at Scott AFB (OFallon, Illinois
  St. Louis area)
• Performs Medical Regulating
• Coordinates the Transportation - Bed plan
• Transportation Command Regulating and Command and
  Control Evacuation System (TRAC ES)
• Combines transportation, logistics, and clinical
  decision elements into seamless patient movement
  capable of assessing/prioritizing medical
  requirements, assigning proper resources
  distributing relevant data

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DOD Role (cont)

• TRANSCOM Regulating and Command Control
  Evacuation System (TRAC ES) Benefits
• Seamless transition from peacetime to natural
• disaster, contingencies and wartime
• In-transit visibility of patient location and
  status
• Integrates different modes of transportation
  (air/ground/sea) for patient movement
• Advanced planning capabilities to develop
  precise plans and projections in resource
  constrained environments
• Effective use of existing transportation
  resources
• Projects limitations and patient movement
  bottlenecks
• Situational awareness for patient recipient
  hospitals

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NDMS Definitive Medical Care
Lead Responsibility - DOD/VA

• Federal Coordinating Centers (FCCs)
• Concentrated in Major Metropolitan Areas
• Air Access
• Available Hospital Support
• Patient Reception and Distribution Capabilities

69
NDMS Definitive Medical Care

• Network of approximately 1,800
• non-Federal hospitals
• Approximately 80,000 beds
• 62 FCCs, which coordinate in
• excess of 82 receiving areas

70
Federal Coordinating Centers
WA
AK
MT
ND
ME
MN
VT
OR
NH
WI
MA
SD
NY
RI
CT
ID
WY
MI
CA
IA
PA
NV
NJ
NE
OH
MD
DE
IL
UT
CO
WV
IN
KS
VA
MO
KY
NC
AZ
OK
NM
TN
SC
TX
AR
AL
MS
LA
GA
FL
USVI
HI
GUAM
PR
Army FCC Navy FCC Air Force FCC VA FCC
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NDMS Participating Hospital Roles

• Voluntary Commit Hospital Support to NDMS

• Provide Bed Availability Information to Local
• NDMS Federal Coordinating Center

• Treat NDMS Patients

• Participate in NDMS Exercises

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NDMS Role in Pandemic Flu Outbreak

• Members are Intermittent Federal Employees
  (Public Law 107-18)
• However, team members are employed
• in their communities

• NDMS team members probably will be required
• to perform their medical duties locally and
  not
• be available for Feral activation

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• DOD and VA assets may be otherwise engaged
• Other events may arise such as Hurricanes or
  earthquakes that require what resources that are
  available.

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• Questions?