DoD Health Care Provider

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DoD Health Care Providers BriefingAnthrax
Vaccine Immunization Program
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Overview

• Anthrax is a biological weapon
• Anthrax is lethal
• Vaccine is safe and effective
• Immunization before exposure, along with wearing
  your mask, is critical
• This is a mandatory vaccination program, like all
  other force health protection vaccines

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Threat

• Anthrax is one of the primary biological weapon
  (BW) threats
• Evidence of production and weaponization by other
  countries
• Northeast Asia
• Southwest Asia

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Anthrax is an Ideal BW Agent

• Spores may survive gt 40 years
• Aerosolized stable spore
• Efficient downwind spread
• Lethal dose could be inhaled with one deep breath
  
• Inhalational anthrax mortality reaches 100

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Microbiology of Anthrax

• Gram positive sporulating rod

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Epidemiology of Anthrax

• Disease of herbivores
• Man infected via animal products
• Dramatic reduction in the U.S. since the early
  1900s
• Still a problem in Asia and Africa

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Pathogenesis

• Spore enters skin, GI tract or lung
• Ingested by macrophages
• Transported to regional lymph nodes
• Germinate in regional nodes, mediastinum
  (inhalational)
• Local production of toxins
• Edema necrosis
• Bacteremia toxemia
• Seeding of other organ systems

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Anthrax Toxin Effects

Edema Factor (EF) MW 89,000
Protective Antigen (PA) MW 83,000
Lethal Factor (LF) MW 90,000
Increased Cyclic AMP
Macrophage Lysis
Local Edema
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Cutaneous Anthrax

• gt 95 of naturally occurring cases
• Spores enter breaks in skin after contact with
  contaminated animal products
• Papule - Vesicle - Ulcer - Eschar
• Up to 20 case fatality rate if untreated
• Mortality with treatment lt 1

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Slide Of Cutaneous Ulcer
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Gastrointestinal Anthrax

• Ingestion of insufficiently cooked meat from
  infected animals
• Nausea, vomiting, fever, abdominal pain
• Mortality may exceed 50 despite treatment

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Inhalational Anthrax

• Incubation period 1-6 days
• Nonspecific symptoms
• Malaise, fever, fatigue, cough, chest discomfort
• Terminal phase
• Dyspnea, stridor, cyanosis, increased chest pain,
  chest wall edema, followed by shock and death
  within 24-36 hours
• Meningitis seen in up to 50 of cases

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Diagnosis of Inhalational Anthrax

• Initial symptoms nonspecific
• Development of respiratory distress
• CXR with widened mediastinum
• Usually no infiltrates
• Sputum not helpful
• Hemorrhagic pleural effusion or meningitis
• Swabs

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CXR of Inhalational Anthrax
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Inhalational Anthrax Treatment

• Early IV antibiotics and intensive care required
• Mortality may still exceed 80
• Penicillin - historical treatment
• Current treatment of choice
• Ciprofloxacin 400 mg IV q 8-12 h
• Doxycycline 200 mg IV x 1 then 100 mg IV q 12 h
• Disease is not spread by respiratory secretions -
  no need for respiratory protection for health
  care providers
• Use Standard Precautions

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Post-Exposure Prophylaxis

• Starting antibiotics within 24 hours after
  aerosol exposure is expected to provide
  significant protection
• Ciprofloxacin 500 mg po BID
• Doxycyline 100 mg po BID
• Most effective when combined with vaccination
• Antibiotics are still indicated even when fully
  immunized

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Anthrax Vaccine

• Licensed since 1970 by the Food and Drug
  Administration (FDA)
• Not a new or experimental vaccine
• Sterile, cell-free (killed) bacterial vaccine
• Contains predominately protective antigen from an
  attenuated strain of Bacillus anthracis
• Prepared from culture supernatant - there are no
  organisms in the vaccine, cannot cause anthrax
  disease
• Adsorbed to aluminum hydroxide
• Contains 0.02 formaldehyde, 0.0025 benzethonium
  chloride as preservatives
• Manufactured by BioPort Corporation (formerly
  known as Michigan Biologic Products Institute)

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Vaccine Quality Control

• Each batch of any vaccine manufactured in the
  U.S. must meet FDA specifications and prescribed
  standards per 21 CFR 620
• Potency, Sterility, Safety, Purity
• Testing done at manufacturer results submitted
  to the FDA
• Prior to release, all stockpiled anthrax vaccine
  lots must pass supplemental testing

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Handling Anthrax Vaccine

• Vaccine must be refrigerated
• Store and maintain between 36 and 46 degrees F
• DO NOT FREEZE
• Once vial opened, use until expired
• Discard if contaminated
• Reference USAMMA web site for guidance on
  questionable vaccine
• http//www.medicine.army.mil/usamma/anthrax/antxho
  me.htm

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Skin
Subcutaneous Tissue
Muscle
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Vaccine Schedule
0 2 weeks 4 weeks 6
months 12 months 18 months
Dose 1 2 3 4
5 6
5 months 6 months 6 months from
3rd

• 6 shots over 18 months, then annual booster

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Standard Interval Between Doses
Between Minimum Interval

• Doses 1 2 - 2 weeks
• Doses 2 3 - 2 weeks
• Doses 3 4 - 5 months
• Doses 4 5 - 6 months
• Doses 5 6 - 6 months

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Anthrax Vaccination Schedule

• The DoD policy is to adhere to the FDA approved
  vaccination schedule
• If documented gap after dose 1 is greater than
  two years, restart the series. Once given dose
  2 or beyond, do not restart the series
• Late doses should be given ASAP - adjust timing
  of subsequent doses according to the standard
  interval schedule

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Access to DoD Medical Treatment Facility (MTF)

• The following designated personnel may receive
  any dose at any MTF
• Active component
• Reserve component (Must be in a duty status)
• Emergency essential DoD civilian and contract
  personnel
• U.S. Coast Guard as applicable
• Mass immunizations require prior coordination
  with MTF

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Response to Vaccine

• Anthrax vaccine, like other vaccines, stimulates
  your body to produce protective antibodies
• Everyone has some antibody response after 2 doses
• The full series is needed to obtain maximum and
  on-going protection
• Everyone gets some protection
• Even with a good antibody response, your defense
  system can be overwhelmed given sufficient number
  of spores

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Animal Models For Human Protection

• Vaccine efficacy has been tested against numerous
  anthrax strains in animal studies
• Guinea pigs and mice are poor animal models for
  anthrax vaccine testing
• Rabbits considered a more appropriate small
  animal model
• Monkeys considered the best model for human
  response

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Evidence Of Efficacy Published Animal Trials

• 30 monkeys vaccinated twice
• Challenged with aerosol at either 8, 16, 38, or
  100 weeks later
• 29 survived (1 died at 100 week challenge)
• 10 monkeys vaccinated once
• Challenged with aerosol 6 weeks later
• All survived
• Overall 98 vaccine protective efficacy

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Vaccine Protection Against Different Strains

• Vaccine efficacy has been demonstrated against
  numerous anthrax strains in animal studies
• Biologic plausibility supports anthrax vaccine
  protection against all strains
• Protective antigen is common to all anthrax
  strains
• Anthrax vaccine protection is expected against
  diverse strains

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Vaccine Efficacy - Inhalational Anthrax

• Human antibody response
• Animal protection data
• Compelling evidence that the vaccine series will
  be effective at preventing disease after an
  aerosol exposure

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Record Keeping

• Automated immunization tracking
• Service systems and DEERS central repository
• Written entries
• Health record (SF-601)
• Adult Preventive and Chronic Care Flowsheet
  (DD form 2766 or DD form 2766C)
• Yellow Shot Card (PHS-731)
• Required documentation
• Date immunized, name of vaccine, manufacturer,
  lot number, series number, dosage, provider name
  and MTF address

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Adverse Reactions

• Mild local reactions (30)
• Redness, tenderness at site for up to 24-72 hours
• Subcutaneous nodules (lumps)
• Moderate local reactions (4)
• Redness/hardness gt5 cm, tenderness, itching for
  up to 24-72 hours
• Severe local reactions rare (lt1)
• Very rare systemic reactions occur (lt0.2)
• Extremely rare systemic reactions (e.g., Guillain
  Barre Syndrome) may occur with all vaccines

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Adverse Event Reporting

• FDA National Vaccine Adverse Event Reporting
  System (VAERS)
• FDA and DoD review 100 of adverse events reports
  submitted to FDA
• Anyone can submit a Form VAERS-1
• A Form VAERS-1 submission is REQUIRED for
• Loss of duty gt 24 hours
• Hospitalization
• Suspected vaccine lot contamination
• Form VAERS-1 may be obtained by calling
• 1-800-822-7967 or at www.fda.gov/cber/vaers.htm.

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Reserve Component Adverse Event Procedures

• An individual experiencing a vaccine-associated
  adverse event in a non-duty status
• Seek medical evaluation at a DoD or civilian
  medical treatment facility if necessary
• Must report the event to their unit commander or
  designated representative as soon as possible
• Form VAERS-1 is the same as Active Duty
• Commander will initiate Line of Duty and/or
  Notice of Eligibility

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Contraindications

• Hypersensitivity reaction to a previous dose of
  anthrax vaccine or vaccine component
• Younger than 18 or older than 65
• HIV positive
• Temporary deferral
• Pregnancy
• Active infection/illness with fever
• Depressed immune response to include
  corticosteroid or other immunosuppressive
  treatment

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Pregnancy

• All vaccinations routinely deferred during
  pregnancy
• Before vaccination, ask all women if pregnant,
  defer vaccination if pregnant
• Continue when no longer pregnant
• No reason to delay pregnancy or conception
  efforts after vaccination
• Breast feeding not a contraindication to
  vaccination

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Conclusions

• Anthrax is a significant threat to our forces
• Anthrax vaccine is safe and effective
• Personal protective measures are still important
• Life saving benefit of anthrax vaccine make this
  a mandatory immunization program
• Vaccination is a crucial part of force health
  protection and readiness

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Information Sources

• Chain of command
• Http//www.anthrax.osd.mil
• Http//www.defenselink.mil
• Http//www.cdc.gov