Smallpox Vaccination:Smallpox Vaccination:Federal ActivitiesFederal Activities
Walter A. Orenstein, M.D.Walter A. Orenstein, M.D.National Immunization ProgramNational Immunization Program
Centers for Disease Control and PreventionCenters for Disease Control and Prevention
Smallpox Preparedness DefinitionSmallpox Preparedness Definition Enhance community awareness and clinician expertise
Perform disease surveillance and laboratory analysis
Implement public health interventions
Provide vaccination
Provide for the capability to rapidly vaccinate greater numbers of responders or the entire population
StrategiesStrategies
1. Surveillance and containment
2. Mass Vaccination
3. Cadre of workers to facilitate 1 and 2
December 13, 2002December 13, 2002 Announcement of U.S. Smallpox Plan Announcement of U.S. Smallpox Plan
The Federal PlanThe Federal Plan
Vaccinate civilian smallpox response teams
Vaccinate Department of Defense personnel
Vaccinate selected staff in overseas assignments
Vaccination not recommended for the general public at present
Advisory Committee on Immunization Practices Advisory Committee on Immunization Practices Supplemental Recommendations, 2002Supplemental Recommendations, 2002
Definition of response teams (to follow)
Vaccination site care
Administrative leave for vaccinated health care workers (not necessary)
Advisory Committee on Immunization Practices Advisory Committee on Immunization Practices Supplemental Recommendations, 2002Supplemental Recommendations, 2002
Screening for contraindications
- Atopic dermatitis, eczema: screening
questions suggested
- Pregnancy
- Immune suppression, including HIV/AIDS
Smallpox Public Health Smallpox Public Health Response TeamsResponse Teams
Public health and medical personnel needed to investigate initial suspected cases and initiate control measures
Includes medical, public health, epidemiologic, laboratory, and nursing personnel, vaccinators, others
Each state should have at least one team
Why Vaccinate Health Care Why Vaccinate Health Care Workers?Workers?
Over 50% of transmission by imported smallpox cases in Europe, 1950-71, occurred in health care settings
About 20% of secondary cases were in health care workers
Mack J, JID 1972;125:161-9.
Why vaccinate Health Care Why vaccinate Health Care Workers?Workers?
Mathematical models suggest contagiousness of smallpox is reduced by about half if health care setting transmission is eliminated
Reason: smallpox spreads from very sick persons, who are usually in hospitals
Gani R, Leach S. Nature 2001;414:748-51
Smallpox Healthcare Smallpox Healthcare Response TeamsResponse Teams
Healthcare personnel from participating hospitals who will be asked to evaluate, manage, and treat the initial suspect/diagnosed cases
Hospitals who choose to participate -- identified by state (and local) public health officials.
Hospitals with assistance from state (and local) public health officials will identify participating healthcare personnel.
SuggestedSuggested Composition of Composition of Healthcare Response TeamHealthcare Response Team
ER: MDs, RNs
ICU: M.Ds, RNs
General medical: RNs; MDs: hospitalists, internists, pediatricians, FP
Housestaff: primary care
Subspecialists: I.D, smallpox experts, dermatologist, ophthalmologist, pathologist
Infection control staffRespiratory therapists
Radiology techsSecurityHousekeeping
Post-attack Program Post-attack Program GuidanceGuidance
Guidance issued October 29, 2002
Plans due to CDC December 2, 2002
Plans presently under review
Post-attack Program Post-attack Program Guidance ElementsGuidance Elements
• Isolation, treatment of cases • Diagnosis • Vaccination of public health, healthcare responders• Surveillance • Containment Activities (contact tracing, vaccination)• Epidemiologic investigation • Large Scale vaccination • Information Management • Communications
Pre-attack Program GuidancePre-attack Program Guidance Guidance issued November 22
Plans due to CDC December 9
Supplements plans for smallpox post-attack control submitted December 2
Pre-attack Program Guidance Pre-attack Program Guidance ElementsElements
Organization and Management
Identification of public health smallpox response teams
Identification of Healthcare Smallpox Response Teams
Selection of Clinic Sites and Vaccination Teams
Scheduling
Pre-attack Program Guidance Pre-attack Program Guidance Elements (continued)Elements (continued)
Vaccine Logistics and Security
Clinic Operations and Management
Vaccine Safety Monitoring
Training and Education
Data Management
Communications
Declaration, Administration of Declaration, Administration of Smallpox Countermeasures, 1/24/03Smallpox Countermeasures, 1/24/03 From Secretary, HHS: reiterated President’s
vaccination recommendations; to last one year
Notes liability protection for those “Determining who is contraindicated; monitoring, management, and care of the countermeasures …”
Countermeasures include vaccine, VIG, cidofovir
Covers health care entities, their employees, agents, and officials
Pre-attack vaccination plans Pre-attack vaccination plans statusstatus
Plans approved for all states, D.C., 3 urban areas (54/62 CDC cooperative agreement recipients; 2/3/03)
Vaccine shipments scheduled for 42 states and cities, 213,700 doses (1/31/03)
165,900 doses already shipped to 30 states and cities (1/31/03)
10 states, 1 city have vaccinated 382 people (1/31/03)
Vaccine Safety Monitoring and Vaccine Safety Monitoring and Response SystemResponse System
Vaccination site monitoring in hospitals, with take checks, summary review at 21-28 days (all vaccinees)
Telephone survey of ~10,000 vaccinees re: common adverse events, work time lost
Clinician Information Line (1-877-554-4625) available 24/7:- links to CDC for VIG, cidofovir release- links to VAERS for reporting
ACIP workgroup monitors system weekly
Pre-vaccination MaterialsPre-vaccination MaterialsCover letterVaccine Information Statement (VIS)VIS supplements:
- Reactions after vaccination
- Vaccination site care
- Skin conditions/contraindications
- Weakened immune system
- Pregnancy
Pre-vaccination Materials Pre-vaccination Materials (continued)(continued)
Screening worksheetContacts’ information sheetVIG informationCidofovir information11 minute videoMedical history and consent formPost-vaccination followup sheet
Training and EducationTraining and Education
19 training and education sessions through 1/30/03
Reached an estimated 800,000 health care professionals
Conducted via classroom, satellite broadcast, CD-ROM, internet, videotape, audioconference
30 different training products available