Download Anthrax Medical Personnel Brief

DoD Health Care
Provider’s Briefing:
Anthrax Vaccine
Immunization Program
Approved: 9 Jun 1999
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Overview
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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
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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Anthrax is an Ideal BW Agent
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Spores may survive > 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
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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
Approved: 9 Jun 1999
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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
Local Edema
Macrophage Lysis
Cutaneous Anthrax
• > 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 < 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
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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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)
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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Handling Anthrax Vaccine
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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/antx
home.htm
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Picture Of Vaccination
45 o
Skin
Subcutaneous
Tissue
Muscle
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Vaccine Schedule
Dose 1
2
3
4
5 months
from 3rd
5
6 months
6
6 months
• 6 shots over 18 months, then annual booster
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Standard Interval Between Doses
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Between
Doses 1 & 2
Doses 2 & 3
Doses 3 & 4
Doses 4 & 5
Doses 5 & 6
Approved: 9 Jun 1999
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Minimum Interval
2 weeks
2 weeks
5 months
6 months
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
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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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 >5 cm, tenderness, itching for up to
24-72 hours
• Severe local reactions rare (<1%)
• Very rare systemic reactions occur (<0.2%)
• Extremely rare systemic reactions (e.g., Guillain Barre
Syndrome) may occur with all vaccines
Approved: 9 Jun 1999
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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 > 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
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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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
Approved: 9 Jun 1999
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Information Sources
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Chain of command
Http://www.anthrax.osd.mil
Http://www.defenselink.mil
Http://www.cdc.gov
Approved: 9 Jun 1999
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