Overview of the NC Smallpox Vaccination Plan A Component of the Public Health Smallpox Preparedness

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Overview of the NC Smallpox Vaccination Plan A
Component of the Public Health Smallpox
Preparedness and Response Plan

• James W. Kirkpatrick, MD, MPH
• Bioterrorism Coordinator
• North Carolina Division of Public Health
• Raleigh, NC

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Warning

• The NCSVP is a confidential document containing
  specific details of a public security plan and is
  therefore exempt from the NC public records law
  according to G.S 132-1.7. The Executive Summary
  and Press Release contain non-classified
  information regarding the NCSVP and are
  considered public documents.

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Phases of the NC Smallpox Preparedness and
Response Plan

• Phase I Baseline
• Phase II Heightened Threat
• Phase III Post-event, limited outbreak
• Phase IV Post-event, large outbreak
• Phase V Recovery

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Components of the NC Public Health Smallpox
Preparedness and Response Plan in each Phase

• Surveillance
• Vaccination
• Outbreak investigation
• Quarantine and isolation
• Mass care
• Mass fatality
• Public information
• Command/Control/Communications

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Assumptions

• Liability and indemnification of state and local
  vaccine providers will be resolved at the federal
  level.
• CDC will provide smallpox vaccine, diluent and
  bifurcated needles for each vaccination stage.
• State and local government will provide all other
  vaccination supplies.
• NC will use CDC forms Surveillance, Contact
  Tracing, Epidemiological Investigation
  Vaccination Guidelines for State and Vaccine
  Adverse Event Reporting.
• Counties may request assistance through
  multi-county assistance compacts NC may request
  assistance through the multi-state Emergency
  Management Assistance Compact.
• In large-scale vaccination, federal government
  will provide additional resources National
  Pharmaceutical Stockpile (NPS), Vendor Managed
  Inventory (VMI) and National Disaster Medical
  Service (NDMS).

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Assumptions-continued

• One-fourth to one-half of those offered pre-event
  vaccination will decline.
• Patient care personnel that decline vaccination
  will be required to sign an indemnification and
  liability release form to continue to work in
  patient care positions.
• Costs to travel to vaccination sites, hours
  and/or salary lost are the responsibility of
  vaccinees or their employers.
• Costs of adverse vaccine reactions are covered
  under employment policies and workers
  compensation laws.
• Local Public Health Directors have primary
  responsibility for requesting smallpox vaccine
  and vaccination resources and for ensuring
  vaccinations within their respective counties.
• Vaccinations will be provided on a voluntary
  basis only.
• Advisory Committee on Immunization Practices
  guidelines will be followed.

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Assumptions-continued

• State and county emergency operations centers
  will be activated and assist with post-event
  vaccination in accordance with existing state and
  local emergency operations plans.
• The State Epidemiologist, Public Health
  Preparedness Response Bioterrorism Coordinator,
  Public Health Regional Surveillance Team
  physician or Local Health Department Medical
  Director will provide standing orders for all
  vaccination scenarios, as necessary.
• NCPH, PHPR, PHRST, and LHD staff will use CDC
  systems for tracking and reporting of vaccination
  activities.
• Adequate amounts of Vaccinia Immune Globulin and
  Cidofovir will be made available.
• CDC personnel/specialists will be available to NC
  as needed and requested.

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Smallpox Vaccines(current as of December 2, 2002)

• DryVax (15.4M doses)
• Re-licensure of vaccine is complete, (diluent is
  pending)
• Oct 25--1.7M doses to DOD
• Upon Presidential Decision--500K for civilian
  vaccination
• Aventis-Pasteur (85M doses)
• IND
• Licensure not being pursued
• Acambis and Baxter (200M doses)
• In production
• Currently an IND
• Licensure projected
• Late 2003 to early 2004

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Scenarios for Vaccination Planning

• Pre-event Scenario
• Pre-event vaccination
• Post-event Scenarios
• Ring vaccination - small number of cases and
  contacts identified
• Mass vaccination - large number of cases and
  contacts identified (or projected)

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Pre-event Vaccination Stages(current as of
December 2, 2002)

• CDC recommendations (tentative)
• Stage One (500,000 US vaccinees)
• Epidemiology investigation/response teams
• Medical, nursing and ancillary staff in selected
  facilities
• Stage Two (10,000,000 US vaccinees)
• First responders EMS, fire/rescue, police, etc.
• Health care workers
• Stage Three
• Following licensure of Acambis/Baxter vaccine
• General vaccination of the population

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NCSVP Pre-event Vaccination Stage One

• Planning processes
• PHPR refines plan in response to CDC comments
• Immunization Branch completes training
• PHPR and PHRSTs assist with coordination and
  planning
• Identify vaccinees
• Coordinate with Wake County HD and host LHDs for
  vaccination dates
• LHDs
• Identify vaccinees and provide names to PHRSTs
• Coordinate with PHRSTs for vaccination dates
• Hospitals
• Identify vaccinees and provide names to LHD and
  PHRST
• Coordinate with LHD and PHRST for vaccination
  locations/dates

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NCSVP Pre-event Vaccination Stage One-continued

• Who will be vaccinated?
• State DPH personnel (20)
• PHRST personnel (35)
• LHD personnel (4-50 each)
• Health Director
• Nursing Supervisor
• Vaccinator(s)
• Disease Investigation Specialist(s)
• Hospital personnel in 54 facilities
• Medical Treatment Team (ca. 100-125 each)
• When will vaccination begin?
• Within 30 days of Presidential announcement
• Where will vaccination occur?
• State personnel Wake County HSC
• PHRST personnel Host HD
• LHD personnel Countys pre-event Vaccination
  Center
• Hospital personnel Option
• Countys pre-event Vaccination Center
• Hospitals occupational medicine clinic

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NCSVP Pre-event Vaccination Stage One-continued

• How will vaccinations be performed?
• IAW current federal guidelines and procedures
• On standing order of NC-licensed physicians
• By NC-licensed, IB-trained and -certified nurses
• Vaccine logistics
• PHPR Pharmacist will coordinate
• Receipt and storage of vaccine at Bath Building
• Division into seven (7) regional packages
• IB personnel and PHPR personnel will deliver
  vaccine to PHRSTs
• PHRSTs will coordinate
• Storage of regional vaccine supply
• Scheduling to minimize vaccine wastage

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NCSVP Pre-event Vaccination Stage One-continued

• Management of vaccination program
• PHRSTs and Regional Immunization Coordinators
  (RICs) will schedule vaccination locations and
  dates
• LHDs (and hospitals where requested) will
• Set up vaccination centers
• Identify personnel to staff centers
• Identify personnel to be vaccinated
• PHRSTs and RICs will operate Mobile Vaccination
  Teams (MVT)
• Transport vaccine and supplies to vaccination
  centers
• Attend and support vaccination centers during
  vaccination
• Visit each location every 1-2 weeks
• Target 10-15 of eligibles per visit
• Carry out record-keeping using the SISS and PVS
  systems
• LHDs (and hospitals where requested) will
• Conduct vaccination
• Monitor vaccination sites for take and reaction
• Report vaccine reactions

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Current ACIP Recommendations for HCWWho in Stage
One

• Hospital based smallpox health care teams
• To provide in-room care for the first smallpox
  patients presenting to ED or requiring hospital
  admission
• 24/7 care for 7-10 days using 8-12 hour shifts

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Current ACIP Recommendations for HCWWho in Stage
One (cont) Total ca. 45 - 125?

• ED staff including physicians and nurses 15
• ICU staff (adult and pediatric) 15
• Physicians
• Nurses
• General medical unit staff in hospitals where
  they provide the bulk of primary care 15
• Internists
• FPs
• Obstetricians

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Current ACIP Recommendations for HCWWho in Stage
One (cont)

• Subspecialists
• Infectious disease specialists
• Dermatologists
• Ophthalmologists
• Pathologists
• Surgeons
• Infection Control Professionals
• Vaccinators and site care clinic workers
• Respiratory therapists
• Radiology techs
• Security
• Housekeeping/transport

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Current ACIP Recommendations for HCWWho in all
Pre-Event Stages (cont)

• Contraindications
• In HCW OR their immediate family
• History of atopic dermatitis or eczema
  irrespective of disease severity or activity
• HCW with burns, impetigo, varicella, herpes,
  severe acne, or psoriasis should wait until
  condition is not active
• Pregnancy (offer testing)
• HIV or other immunocompromising state (offer
  testing)

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Current ACIP Recommendations for HCWHow for all
Pre-event Stages

• Administrative leave
• Not routinely recommended
• Up to 1/3 may become too ill to work
• Other considerations
• Start with previously vaccinated, if possible
• Stagger same unit personnel to minimize number
  simultaneously out of work

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NCSVP Pre-event Vaccination Stage Two

• Planning processes
• PHPR and PHRSTs assist with coordination and
  planning
• Collect regional vaccination requirements
• Coordinate with LHDs for vaccination dates
• Plan MVT activities
• LHDs
• Collect county vaccination requirements
• Collect and provide names to PHRSTs
• Coordinate with PHRSTs for vaccination dates
• Establish secondary vaccination locations if
  required
• Employers
• Identify vaccinees and provide names to LHD and
  PHRST
• Coordinate with LHD for vaccination
  locations/dates
• Request on-site or occupational medicine clinic
  vaccination, if desired

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NCSVP Pre-event Vaccination Stage Two-continued

• Who will be vaccinated?
• Clinical and office staff
• Hospital personnel in general care facilities
• First responders
• Law enforcement
• Fire and rescue
• EMS
• Hazardous Materials response teams
• State Medical Response System personnel
• Selected National Guard personnel
• When will vaccination begin?
• Upon direction from federal government
• Upon receipt of adequate vaccine supplies
• Would take 3-6 months to complete

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NCSVP Pre-event Vaccination Stage Two-continued

• Where will vaccination occur?
• As in Stage One
• LHDs may establish additional vaccination
  locations
• Employers may request vaccination in their own
  occupational medicine clinics or on site
• How will vaccinations be performed?
• As in Stage One
• Vaccine logistics
• As in Stage One
• Management of vaccination program
• As in Stage One
• Additional locations if required

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NCSVP Post-Event Ring Vaccination

• Planning processes
• Component of Phase III of overall NC Smallpox
  Preparedness and Response Plan
• Occurs when cases of smallpox or contacts of
  cases are identified in NC
• PHPR and NCEM will be at full activation
• NC EOP in operation
• HAN will alert all NC public health entities
• Logistical, strategic and operational information
  will be transmitted via EM2000 to NCEM and county
  EOCs
• NCPH and NCEM will request an emergency
  declaration from the Governor who may request a
  declaration from the President

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NCSVP Post-event Ring Vaccination-continued

• Who will be vaccinated?
• Contacts of smallpox cases identified by disease
  investigation
• Contacts of contacts
• When will vaccination begin?
• When confirmed contacts are identified
• Where will vaccination occur?
• LHDs will expand existing pre-event Vaccination
  Center
• LHDs may open additional vaccination locations as
  required
• Preferably locations identified for mass
  vaccination in Phase IV

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NCSVP Post-event Ring Vaccination-continued

• How will vaccinations be performed?
• As in previous phases
• Additional personnel requested through county EOC
  to state EOC
• Vaccine logistics
• LHDs will compile requests and requirements for
  vaccine, supplies, and other resources
• Transmit to NCPH
• Provide to county EOC for forwarding to state EOC
• NC will request additional resources from federal
  sources
• Receipt and distribution procedures will be as in
  previous phases
• Additional support may be requested from SERT

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NCSVP Post-event Ring Vaccination-continued

• Management of vaccination program
• PHRSTs and Regional Immunization Coordinators
  (RICs) from non-impacted regions may be
  transferred to impacted regions
• LHDs and their countys emergency management
  systems may request additional resources from
• Neighboring counties
• State EOC
• Tracking of vaccinees, takes, non-takes, adverse
  reactions and revaccinations will be IAW CDC
  systems

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NCSVP Post-Event Mass Vaccination

• Planning processes
• Component of Phase IV of overall NC Smallpox
  Preparedness and Response Plan
• Occurs when
• cases of smallpox or contacts of cases exceed
  capacities to conduct contact tracing, OR
• political decision is made to vaccinate
  population.
• Ring vaccination continues for identified
  contacts
• Command and Control policies and procedures from
  Phase III remain in effect

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NCSVP Post-event Mass Vaccination-continued

• Who will be vaccinated?
• Identified contacts of cases
• All North Carolinians
• Using most current federal guidance
• When will vaccination begin?
• Upon declaration by the Governor or President
• Upon receipt of vaccine
• Where will vaccination occur?
• LHDs will request their counties to open mass
  vaccination centers identified in Smallpox
  Vaccination Planning Database
• Locations and POC as listed in Chapter VIII of
  NCSVP

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NCSVP Post-event Mass Vaccination-continued

• How will vaccinations be performed?
• As in previous phases
• Additional personnel requested through county EOC
  to state EOC
• Governor may waive NC licensure requirements for
  physicians and/or nurses
• Using most current CDC procedures for
  establishing and operating mass vaccination
  centers
• Vaccine logistics
• As in Ring Vaccination
• Management of vaccination program
• As in Ring Vaccination

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Post-event Deactivation

• Planning processes
• Component of Phase V of overall NC Smallpox
  Preparedness and Response Plan
• Initiated when no new smallpox cases had appeared
  for one or more incubation periods
• Vaccination locations would close as requirements
  diminish
• Temporary and borrowed personnel would be
  released
• Vaccine logistics
• Unused vaccine would be stored securely or
  returned to CDC
• Unused NPS resources may be returned to CDC at
  their discretion
• Command and Control
• State EOC and NCPH Crisis Center reduce
  activities
• NCPH, PHRSTs and LHDs conduct after-action
  reviews
• NCPH and PHPR develop and distribute Lessons
  Learned
• NCPH conducts a financial audit of the cost of
  response for performance analysis and application
  for reimbursement

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Delivery of Vaccine to the Local Level Use of
the NPS

• State will contact CDC to request vaccine from
  National Pharmaceutical Stockpile
• State NPS plan
• Receive vaccine at designated location
• Distribute to counties
• Each county or multi-county LHD should have a
  local plan to take delivery from the State
• Location
• Contact information 24/7
• Security
• Accountability
• Distribute to VC(s)

In the Smallpox Vaccination Planning Database
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NPS Vaccine Logistics

• First day vaccine supply comes in a
  self-contained, self-powered refrigerator called
  a Vaxicool
• 150,000 doses (maximum)
• Medical supplies
• Diluent
• Bifurcated needles
• Transfer needles
• Forms
• 3 ea. 48-inch pallets
• VIG and cidofovir by separate request
• Localities (or state) provide other
  medical-related items
• 2X2 gauze
• Air permeable dressings
• Ziplock bags
• Sharps containers
• Medical waste bags

This is not the 50-ton NPS Push Package
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Smallpox Vaccination Training

• State-wide PHTIN Broadcasts
• Oct 17
• Oct 30
• Dec 3
• Dec 5-6 (CDC training event)
• Train the Trainer training for PHRSTs
• 7 scheduled through Dec 18
• All LHDs
• By End of Calendar Year

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Smallpox Vaccination Planning Database(Informatio
n is provided by counties)

• Pre-event Vaccination Center
• Location
• POC
• Projected Vaccinees
• Stage One
• Stage Two
• Trained Vaccinators
• Mass Vaccination Centers
• Location
• POC
• Manpower Available
• NPS Smallpox Vaccine Reception Point and POC

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Smallpox Vaccination Planning DatabaseStatus
ReportDecember 3, 2002

• Reports Received 94 Counties
• Pre-event Vaccination Centers
• LHDs 87
• Others 7
• Total Vaccinees for Pre-event Vaccination
• Stage 1 37,000
• Stage 2 276,000
• Numbers of Vaccinators to be trained 357
• Mass Vaccination Centers 379
• People Available for Mass Vaccination 91
  counties reported, all had shortages
• Locations for NPS Smallpox Vaccine delivery 67

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What do PHRSTs, LHDs and Hospitals need to do now?

• PHRSTs assist with coordination and planning
• Identify vaccinees
• Coordinate with host LHDs and Wake County HD for
  vaccination dates
• LHDs
• Complete entries into smallpox vaccination
  planning database
• Complete vaccinator training
• Recheck Stage One numbers
• Identify vaccinees and provide names to PHRSTs
• LHD eligibles
• Hospital eligibles
• Coordinate with PHRSTs for vaccination dates
• Hospitals
• Identify vaccinees and provide names to LHD and
  PHRST
• Coordinate with LHD and PHRST for vaccination
  locations/dates

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What information do we need to finish pre-event
planning?

• Vaccine
• How many doses will NC be allotted?
• What is the post-reconstitution shelf-life?
• Final Guidelines from US DHHS
• Selection and prioritization of vaccinees
• Screening of individuals for contraindications
• Contact and occupational limitations of vaccinees
  
• Liability and indemnification
• Workers compensation

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Information Resources

• CDC Interim Smallpox Plan (www.bt.cdc.gov)
• CDC Smallpox Vaccination Clinic Guide
  (www.bt.cdc.gov)
• NPS Smallpox Distribution Plan (www.nchan.org)
• NC Smallpox Vaccination Plan (www.nchan.org)
• Executive Summary
• Press Release
• Slides from today
• Office of Public Health Preparedness Response
• [phone]
• (jim.kirkpatrick_at_ncmail.net)

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The North Carolina Division of Public Health
QUESTIONS?