1. Smallpox Vaccination: Federal Activities Walter A. Orenstein, M.D. National Immunization Program Centers for Disease Control and Prevention

2. Smallpox 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

3. Strategies 1.Surveillance and containment 2.Mass Vaccination 3.Cadre of workers to facilitate 1 and 2

4. December 13, 2002 Announcement of U.S. Smallpox Plan

5. The 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

6. Advisory Committee on Immunization Practices Supplemental Recommendations, 2002 Definition of response teams (to follow) Vaccination site care Administrative leave for vaccinated health care workers (not necessary)

7. Advisory Committee on Immunization Practices Supplemental Recommendations, 2002 Screening for contraindications -Atopic dermatitis, eczema: screening questions suggested -Pregnancy -Immune suppression, including HIV/AIDS

8. Smallpox Public Health Response 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

9. Why Vaccinate Health Care 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.

10. Why vaccinate Health Care 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

11. Smallpox Healthcare Response 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.

12. Suggested Composition of Healthcare 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 staff Respiratory therapists Radiology techs Security Housekeeping

13. Post-attack Program Guidance Guidance issued October 29, 2002 Plans due to CDC December 2, 2002 Plans presently under review

14. Post-attack Program Guidance 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

15. Pre-attack Program Guidance Guidance issued November 22 Plans due to CDC December 9 Supplements plans for smallpox post-attack control submitted December 2

16. Pre-attack Program Guidance Elements Organization and Management Identification of public health smallpox response teams Identification of Healthcare Smallpox Response Teams Selection of Clinic Sites and Vaccination Teams Scheduling

17. Pre-attack Program Guidance Elements (continued) Vaccine Logistics and Security Clinic Operations and Management Vaccine Safety Monitoring Training and Education Data Management Communications

18. Declaration, Administration of Smallpox 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

19. Pre-attack vaccination plans status 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)

20. Vaccine Safety Monitoring and Response 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

21. Pre-vaccination Materials Cover letter Vaccine Information Statement (VIS) VIS supplements: -Reactions after vaccination -Vaccination site care -Skin conditions/contraindications -Weakened immune system -Pregnancy

22. Pre-vaccination Materials (continued) Screening worksheet Contacts’ information sheet VIG information Cidofovir information 11 minute video Medical history and consent form Post-vaccination followup sheet

23. Training 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

24. To Be Determined Process for vaccination of -traditional first responders -additional health care workers -general public