Anthrax Vaccine
Immunization Program
Introduction
Biological warfare remains a constant threat to U.S. forces. Anthrax has been
identified as the primary biological weapon facing American service men and women today.
The greatest concern is inhalation anthrax; the form of anthrax that is expected following
an attack with aerosolized anthrax spores. This is 99 percent lethal for unvaccinated
individuals. After a 3 year study, the Secretary of Defense William S. Cohen concluded
that anthrax vaccination, used with other protective measures such as detectors and
protective gear, is the safest way to protect highly mobile U.S. military forces against
inhalation anthrax. In March 1998, DoD began immunizing personnel deploying to or
stationed in high threat areas, currently defined as Southwest Asia and the Korean
Peninsula, and their contiguous waters. Over the next five years, all active and Reserve
personnel will be immunized using a prioritized vaccination schedule.
Anthrax Vaccine: a historical
perspective
The anthrax vaccine used by the U.S. military was approved and licensed by the Food
and Drug Administration in 1970. It is the same vaccine used by civilians in occupations
at increased risk of contracting anthrax, such as veterinarians, animal handlers, and wool
sorters. The vaccine is now being manufactured by BioPort Corporation (formerly the
Michigan Biologic Products Institute). It is made from a culture of attenuated strains of
anthrax that is filtered, so that it contains predominantly a protective antigen. There
are no whole bacteria in the product, and it is impossible to contract the disease from
the vaccine.
The vaccine was originally developed to protect against cutaneous anthrax, but in the
studies for FDA-licensure, there were 5 cases of inhalation anthrax in the placebo group
and no cases of inhalation anthrax in the vaccinated group. However, there were not enough
inhalation anthrax cases to prove efficacy against an inhalation challenge. To show the
effectiveness of the vaccine in preventing disease after an aerosol challenge, animal
studies using Rhesus monkeys have been performed. In three separate studies, using a total
of 43 monkeys who received either one or two doses of the vaccine, and received an aerosol
challenge 90 to 400 times the lethal dose, only one monkey died while the other 42
survived.
Recommended vaccination schedule
6 subcutaneous, 0. 5 ml doses should be given on days 0, 2 weeks, 4 weeks, 6
months, 12 months, and 18 months, followed by annual booster dose to maintain immunity. If
an individual is late for their next dose, the series will not need to be restarted unless
more than 2 years have elapsed between doses one and two. Otherwise, simply give the next
dose in the series as soon as possible, with administration of subsequent doses based on
the required intervals from the last dose given.
Documentation of Immunization
Administration of the anthrax vaccine (like all other vaccines) will be documented
in three locations: the medical record on the SF-601 (Anthrax Immunization Record
overprint), the yellow shot card (PHS-731), and in the automated immunization tracking
system (currently SAMS (Shipboard Automated Medical System)). Required data elements are
listed in references (a) and (b). Reference (a) outlines procedures for ordering anthrax
vaccine.
Immunization site reactions can include soreness, redness, and localized swelling
(resolution occurs within hours to days). About thirty percent of individuals who receive
the anthrax immunization will develop a non-tender subcutaneous nodule that will resolve
on its own within a few weeks to months. There have been no long term sequelae or side
effects from this vaccine. Adverse reactions to the anthrax vaccine that result in
hospitalization, lost work time greater than 24 hours, or suspected lot contamination must
be reported on the Health and Human Services' Vaccine Adverse Event Reporting System
(VAERS) form, which is sent to the Navy Environmental Health Center (NEHC). However, at
the discretion of the provider or patient, any adverse event can be reported using the
VAERS form. Information on how to complete VAERS can be found in references (a), (b), and
(c).
Important points on the Anthrax vaccine
The vaccine is licensed only for use in individuals from 18 to 65 years of age.
Hypersensitivity to previous doses of anthrax vaccine or any of its components is a
potential contraindication to receiving additional doses. Reference (b) addresses
deferrals based on hypersensitivity. Reasons for temporary deferment of the vaccine
include active infection with fever, currently taking immune suppressing drugs such as steroids, or pregnancy (unless anthrax exposure occurs or is imminent). Vaccinations
should be resumed when these issues are resolved. Immunosuppressed individuals may not
develop an adequate immune response to the vaccine.
Like many other vaccines in the U.S., anthrax vaccine is classified as "pregnancy
category C," which means that animal reproduction studies have not been conducted
with the vaccine. The CDCs Advisory Committee on Immunization Practices states,
"there is no convincing risk from vaccinating pregnant women with inactivated
virus or bacterial toxoids." Since the anthrax vaccine is derived from a culture of
killed bacteria which is strained to remove any potentially infectious elements, there is
no biological plausibility for it to pose any greater risk to a developing fetus than
other bacterial vaccines. Therefore, if the vaccine is inadvertently given to a pregnant
woman, no adverse pregnancy outcome is expected. Since the vaccine contains no infectious
components, there is no reason to delay pregnancy after receiving a dose of vaccine or to
stop breastfeeding.
Though the anthrax vaccine will be required of all service personnel, it is currently
mandated for all military personnel in designated units, unless deferred or exempt for
medical reasons. Reference (b) outlines medical exemption and religious waiver procedures. Personnel that decline anthrax vaccination will face legal action from their commanding
officers for disobeying a lawful order. See reference (a).
DoD has produced a number of training materials and products using subject matter
experts from all the services to educate medical personnel, commanders, and individual
patients. Before receiving the anthrax vaccine, all personnel must:
All of the briefing materials, as well as other resources, can be found on the NEHC
home page at http://www-nehc.med.navy.mil/prevmed/immun/anthrax.htm
The DoD website. http://www.defenselink.mil/other_info/qanda.html
also contains additional information of interest to military members and their families
about the anthrax program.
References
-
SECNAVINST 6230.4 Department of the Navy (DON) Anthrax Vaccination Implementation
Program (AVIP)
-
BUMEDINST 6230.15 (Immunizations and Chemoprophylaxis)
-
Clinical Practice Guidelines for Managing Adverse Events after Anthrax or other
Vaccinations. Issued 15 Nov 99 by the Anthrax Vaccine Immunization Program (AVIP) Agency,
within the Office of the Army Surgeon General. (Guideline updates are located at http://www.anthrax.osd.mil and the Navy
Environmental Health Center website, http://www-nehc.med.navy.mil
Written by LCDR Ann Fallon, MC, USN, Headquarters USMC, Arlington Annex,
Arlington, VA (1999).
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Preface
· Administrative Section
· Clinical Section
The
General Medical Officer Manual , NAVMEDPUB 5134, January 1, 2000
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