1. Back to the Future? Pre-Event Smallpox Vaccination John R. Lumpkin, MD, MPH, FACEP Illinois Department of Public Health

2. Is it safe to defer pre-event vaccination? Vaccination within 3 days of exposure to a case prevents or significantly mitigates disease IDPH and the Governor have prioritized health-care worker vaccinations in the setting of a smallpox outbreak 30% of young adults vaccinated in the fall of 2001 at the CDC had to take 2 days off due to side effects of the vaccine

3. What’s the purpose of Phase I vaccination? Immunize public health and health- care workers who might be exposed to some of the earliest smallpox cases or be essential in caring for them Phase I will not immunize all health-care workers who may or will be exposed to a smallpox case

4. HICPAC-ACIP Recommendations October 2002 Smallpox Health Care Teams (SHCTs) Screening for contraindications Vaccination site care Administrative leave

5. HICPAC: SHCTs Each acute care hospital should identify a SHCT Purpose of the SHCT  Evaluate and manage patients in the ED  Provide in-room care for first 7 to 10 days  Need to cover all shifts

6. HICPAC: SHCTs (cont’d) ED and ICU physicians and nurses, including pediatric expertise General medical staff, including ob and surgeons House staff Subspecialists (ID, dermatologists, pathologists) Infection control professionals Respiratory therapists, radiology technicians, environmental services

7. HICPAC: SHCTs (cont’d) “ Although it is not recommended that emergency medical technicians (EMTs), as a group, be vaccinated in this first phase, individual hospitals may identify and include hospital-based EMTs (i.e., personnel who would be dispatched to transport patients with suspected smallpox)”

8. HICPAC-ACIP: Site Care Daily dressing checks by staff designated by the hospital “Health-care workers involved in direct patient care should keep their vaccination sites covered with gauze…and a semi-permeable dressing …until the scab separates.” At home: gauze dressing

9. HICPAC-ACIP: administrative leave “Administrative leave is not required routinely for newly vaccinated healthcare workers unless they are physically unable to work…or if they do not adhere to the recommended infection control precautions.” “It is important to realize that the very close contact required for transmission of vaccinia to household contacts is unlikely to occur in the healthcare setting.”

10. Pre-event contraindications 1. Pregnancy: current or planned within 4 weeks 2. Breast-feeding 3. Immunosuppression (including immunosuppressive diseases [HIV], conditions [lupus], therapies [post- transplant])

11. Pre-event contraindications (cont’d) 4. Eczema or atopic dermatitis 5. Serious skin conditions not under control (psoriasis, severe acne, large burns, etc) 6. Close contact with people who have conditions noted in numbers 1 through 5

12. Pre-event contraindications (cont’d) 6. Significant allergies to any of the antibiotics used in the manufacture of the vaccine (streptomycin, tetracycline, chloramphenicol) or latex 7. Close contact with children less than 1 year old

13. Implementation of Phase I Exact date still uncertain IDPH will receive the vaccine and distribute to local health departments (LHDs) LHDs will establish vaccination clinic hours, administer vaccine Follow-up (dressing checks and assessment of “take”) at the hospital

14. What will happen at the vaccination clinic? Volunteers will watch a 20 minute video provided by the CDC Volunteers will be asked to sign an informed consent form Vaccination given intradermally above right deltoid Vaccinees given site instructions and proof-of-vaccination card

15. Follow-up Each hospital will designate a hospital-assigned physician (HAP); this person will be your resource if you have questions prior to vaccination or complications after

16. Expected Side Effects Temp up to 102º Malaise Erythema, tenderness up to10 cm Axillary adenopathy 30% of the young adults vaccinated at the CDC in the fall of 2001 had to take 1- 2 days off because of side effects; this peaked at day 8 after the vaccination

18. Assessing “take” The HAP at each hospital will evaluate “take” on day 7, 8, 9, or 10 after vaccination

19. Complications 1000 per every million vaccinees in the past  Most common complications: autoinnoculation and disseminated vaccinia, both usually self-limited and insignificant  Eczema vaccinatum (30:1,000,000)  Progressive (necrotizing) vaccinia in people with cellular immunodeficiencies 1 death per million for first time vaccinees; 1 in 4 million for previously vaccinated

20. Liability Issues People administering vaccine protected by Homeland Security Act Vaccinees who inadvertently innoculate another person (patient, household contact)--HSA does not offer liability protection

21. Compensation for days off due to expected side effects?

22. Miscellaneous information Duration of immunity: 3 to 5 years (you’ll need to be revaccinated if smallpox remains a threat) What about the “new” vaccine? It will still be a live virus, just produced in cell culture instead of on the side of a cow.