1 DoD Smallpox Vaccination Program Policy – Training – Standards – Communication – Safety Assurance – Safety Assessment Science – Quality – Confidence – Care 29 Jan 03 COL John D. Grabenstein, RPh, PhD Deputy Director for Military Vaccines Office of the Army Surgeon General

2 DoD Smallpox Vaccination Policy Announced by President Bush, 13 Dec 02. –Vaccinating troops before an attack is best way to ensure they are protected and can continue their missions. Several Stages: –Stage 1a: Smallpox Epidemic Response Teams (SERTs). 2,000 to 5,000 people, beginning mid-Dec 02. –Stage 1b: Medical Teams for Hospitals & Large Clinics. 10,000 to 25,000 people, beginning early Jan 03. –Stage 2: Mission-Critical Forces, especially CENTCOM. Up to 500,000 troops, beginning early Jan 03. Clinical policies consistent with FDA, CDC, and ACIP.

3 DoD Smallpox Vaccination Program as of 31 Jan 03: Healthcare workers vaccinated:3,665 * * # of combat troops vaccinated not released publicly; provided to CDC & FDA, along with all other safety-surveillance data. People exempted from smallpox vaccine:10% to 40% * * Includes both admin + clinical exemptions, varies by setting –Self > household Skin > immune > pregnancy > allergy Take: Primary— 3 jabs,96%(186/194) Revaccination—15 jabs, 99%(297/298) Adverse Events: Expected temporary reactions seen. –3% overall lost one or more days of work. Primary—4% to 5%. Revaccination—1% to 2% –Significant Adverse Events: Encephalitis-1-recovered. GV-1-mild. –Patients needing vaccinia immune globulin (VIG): zero. –Deaths: zero.

4 Screen & Vaccinate Acute Events Chronic, Rare, Delayed, Unexpected Vaccinia Safety Assessment Day 6 to 8 (“take”) Vaccination Day Days 0 to 30Months to Decades Sick-call surveillance Exempt?Take? Rate?Inadvertent inoculation How many? Why?Symptoms:Eczema vaccinatum Which? Rate? Severity?Progressive vaccinia Allergic reactions?Sick call:Encephalitis Why? How often?Hospitalizations, etc. How many doses / vial? Limited duty:Vaccinia immune globulin (VIG) requests Why? How long? Time course?CDC: Prospective pregnancy registry Vaccine Adv Event Rpt System (VAERS) Analyzable medical notesAnalyzable medical notes Defense Medical Surveillance System 30-day diary cardsVaccine Healthcare Ctr (VHC) referrals Def Med Surveillance System VIG requests (DMSS)Millennium Cohort Study ThousandsThousandsAll Sociologic Studies Human Factors 17 Dec 02

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10 Precautions in Vaccination Education up front and throughout process Screening for contraindications (same as FDA and ACIP) Periodic HIV screening Pregnancy screening and testing QA of Vaccinator: Evaluate take rates among first cohort of people (e.g., 50 to 100) vaccinated by each vaccinator Healthcare Workers: Bandages, sleeves, hand-washing, site- evaluation stations Military-Unique Settings: No hot-bunking with vaccine exempt Documentation: Screening, Vaccination, Take Confirmation, Adverse Events VIG prepositioned around globe, regionally

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14 Smallpox Vaccination Program – Lessons SVP medical training essential: Screening forms, handouts revised: – Take due care in conducting screening Ample time for questions, screening. Have MD/PA/NP on site Accept verbal history of prior vaccination (supplement with scar, birth date, military entry) Team of 2: The vaccinator and the bandager/documenter Confirm “trace of blood” at vaccination site Place open vial at back of vaccination station, use cool tray Operate bandage-check station for healthcare workers Notify local health departments Check “take” 6-8 d later, triaged, decentralized

15  Chain of Command  Website:   Toll-Free: 877.GET.VACC  CDC National Immunization Hotline:  CDC Bioterrorism Information:  Walter Reed Vaccine Healthcare Center, for help with complicated adverse-event management:  For information on civilian health-care services for members not enrolled to a Military Treatment Facility:  Call: 888.MHS.MMSO ( ) Communication & Information