DoD Smallpox Vaccination Program

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DoD Smallpox Vaccination Program

Policy – Training – Standards – Communication – Safety Assurance – Safety Assessment

Science – Quality – Confidence – Care

29 Jan 03

COL John D. Grabenstein, RPh, PhDDeputy Director for Military VaccinesOffice of the Army Surgeon General

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DoD Smallpox Vaccination PolicyDoD 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.

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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.

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Screen & Vaccinate Acute Events Chronic, Rare, Delayed, Unexpected

Vaccinia Safety AssessmentVaccinia Safety Assessment

Day 6 to 8 (“take”)Vaccination Day Days 0 to 30 Months to Decades

Sick-call surveillance

Exempt? Take? Rate? Inadvertent inoculationHow many? Why? Symptoms: Eczema vaccinatum

Which? Rate? Severity? Progressive vacciniaAllergic 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 notes Analyzable medical notes Defense Medical Surveillance System

30-day diary cards Vaccine Healthcare Ctr (VHC) referralsDef Med Surveillance System VIG requests

(DMSS) Millennium Cohort Study

Thousands Thousands All Sociologic Studies Human Factors

17 Dec 02

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Precautions in VaccinationPrecautions 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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Tools & ResourcesTools & Resources

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Smallpox Vaccination Program – Lessons Smallpox Vaccination Program – Lessons

• SVP medical training essential: www.smallpox.army.mil • Screening forms, handouts revised: www.smallpox.army.mil

– 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

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Chain of Command Website: www.smallpox.army.mil, www.anthrax.mil E-Mail: [email protected] Toll-Free: 877.GET.VACC CDC National Immunization Hotline: 800.232.2522 CDC Bioterrorism Information: www.bt.cdc.gov Walter Reed Vaccine Healthcare Center, for help with

complicated adverse-event management: 202.782.0411 [email protected] www.vhcinfo.org

For information on civilian health-care services for members not enrolled to a Military Treatment Facility: Call: 888.MHS.MMSO (888.647.6676)

Communication & Information Communication & Information