Post on 12-Jan-2016
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, PhDDeputy Director for Military VaccinesOffice of the Army Surgeon General
2
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.
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 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
5
6
7
8
9
10
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
11
Tools & ResourcesTools & Resources
12
13
14
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
15
Chain of Command Website: www.smallpox.army.mil, www.anthrax.mil E-Mail: vaccines@amedd.army.mil 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 Askvhc@amedd.army.mil 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