DoD Biodefense Vaccination Programs

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• DoD Biodefense Vaccination Programs
• Science Quality Confidence Care
• 7 May 03
• COL John D. Grabenstein, RPh, PhD
• Military Vaccine (MILVAX) Agency

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DoD Biodefense Vaccination Programs14 May 03

• Anthrax vaccine
• Mar 98 to Aug 02 2,123,017 doses to 528,763
  people
• Sep 02 to May 03 899,253 doses to 423,831
  people
• Mar 98 to May 03 3,022,270 doses to 870,230
  people
• Worldwide shipping, education, communication at
  all levels
• Smallpox vaccine
• Unparalleled educational effort around the world
• Dec 02 to May 03 520,758 screened, 438,104
  vaccinated
• Zero cases of severe skin conditions (careful
  screening)
• Serious adverse events at or below historical
  rates
• Surveillance identified increased risk of
  myo-pericarditis in male primary vaccinees, 7 to
  19 days after vaccination
• Assistance to civilian smallpox vaccination
  programs

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Most Common COSTART Terms Within VAERS Reports
For Anthrax Vaccination
Subject to an impressive variety of biases.
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DoD Smallpox Vaccination Program as of 14 May 03

• Response teams, hospital workers, operational
  forces vaccinated
• 438,104. Male 87, Female 13 Primary 70,
  Revaccination 30.
• Exemption rates vary by location and setting
• Exemption Personal 4.9 to 7.8. Personal
  household 11 to 34
• Take Primary, 3 jabs 96.
  Revaccination, 15 jabs 96
• Adverse Events Expected temporary symptoms
  seen.
• Sick leave Hospital staff 3. In theater
  0.5. Average 1.5 days
• Noteworthy Events
• Generalized vaccinia36, all mild, all recovered.
  
• Inadvertent infectionSkin Self36, Contact17,
  all recovered.
• Inadvertent infectionEye Self10, Contact
  2, all recovered.
• Contact transfer Spouse10, intimate contact5,
  friend4, patient0
• VIG treatments Burn-1, eye-1.
• Encephalitis1 recovered.
• Myo-pericarditis Suspect8, probable26,
  confirmed1.
• Eczema vaccinatum zero Progressive vaccinia
  zero Deaths zero

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DoD Smallpox Vaccination Program Cardiac cases,
as of 14 May 03

• Personnel vaccinated 438,104 Male 87,
  Female 13
• Primary vaccination 307,549 (70)
  Revaccination 130,555 (30)
• Myo-pericarditis Suspect8, probable26,
  confirmed1. Pending4
• Onset interval 7 to 19 d.
• Male 18/18 Age 21 to 33 years
• Primary vaccination 18/18 Present with chest
  pain 18/18
• Enzymes elevated 18/18 ECGST changes 16/18
• Echoabnormal 10/18 Recovery 18/18 (follow-up
  planned)
• Relative risk 6 for 2-week interval, 3 for
  4-week interval
• Conclusion Smallpox vaccination increases risk
  of myo-pericarditis

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DoD Smallpox Vaccination Program Cardiac cases,
as of 14 May 03

• Ischemic events Probable7. Onset interval 2
  to 14 days
• MI3 (1 fatal), angina2, coronary spasm1,
  atrial fib1.
• Recategorizations 2 MIs, 1 angina to
  myocarditis.
• Fatality 55 y/o smoker w/ 3-vessel coronary
  occlusion, left ventricular hypertrophy,
  cardiomegaly, no myocarditis.
• Expected ischemic admissions, 14-day window25,
  upper 95 CI30
• Cardiovascular deaths, Army average 50 per year.
• DVT fatal PE 31 days post vaccination. Factor
  V heterozyg. Autopsy.
• Conclusion Ischemia after vaccination does not
  exceed expected level.

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DoD Smallpox Vaccination Program Cardiovascular
Fusion Group, as of 14 May 03

• Cardiologists, immunologists, other clinicians,
  epidemiologists, et al.
• Major clusters of activities
• Acute care consultation uniform quality
  clinical guidelines.
• DoD Vaccine Clinical Call Center at
  866-210-6469.
• Limited physical activity at own pace for 6
  weeks.
• (2) Centralized case review), using CDC-DoD case
  definition
• suspected, probable, confirmed. association is
  principally temporal
• Registry maintained by Vaccine Healthcare
  Centers
• (3) Long-term follow-up Repeat troponin, ECG,
  echocardiogram, graded exercise test at 6 wk, 6
  mo, and 12 mo after discharge.
• Decentralized tests, central evaluation.
• (4) Surveillance activities and clinical studies.
  
• Case-control studies to define risk factors and
  clinical spectrum
• Immuno-genetic analysis
• Prospective studies of vaccinees healthcare
  utilization, self-reported symptoms and
  functional status in the first two years after
  vaccination.

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Response to AFEB Evaluation, 18 Feb 03
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Screening Before Smallpox Vaccination15 May 03
n 1,643
Further analyses planned
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Symptoms Since Vaccination

• Day 6-8, Take Check, symptoms since
  vaccination, n 526, Jan-Feb 2003
• Local itching 60 Muscle ache 21
• Feeling lousy 20 Lymph nodes swell 14
• Headache 18 Bandage reaction 7.4
• Itchy all over 5.5 Fever (subjective) 5.3
• Local rash 5.3 Body rash 1.1
• Eye infection 0.0
• Restricted activity 1.3 Took medication 17
• Outpatient visit 0.8 Limited duty 0.0
• Missed work 0.2 Hospitalized 0.0