Anthrax vaccine warnings:
An informational insert is provided to explain usage, dosage, warnings and possible side
effects of the anthrax vaccine. Those administering and those receiving the vaccine should
be provided this necessary information.
Unfortunately, the printed insert that accompanies the anthrax vaccine has been almost
impossible to obtain. This is the insert that should be provided and available to all
physicians and patients who may administer/receive the anthrax vaccine.
Please note the following:
1. Under the "indications and usage" section there is no reference for using the
vaccine for "inhaled anthrax."
2. Under "contraindications" it states that a previous severe reaction would be
reason to defer the vaccine. During the Gulf War, few, accurate medical records or shot
records were maintained, therefore, the possibility exists that one would not be aware if
he had a previous reaction to anthrax vaccine.
3. Under "warnings" any acute respiratory disease or other active infection is
generally considered to be adequate reason for deferring an injection. During the Gulf
War, the majority of the troops stated they had no choice whether or not they received the
injections.
4. Under "precautions" Epinephrine solution should always be available in case
of an anaphylactic reaction (cessation of breathing and shock).
5. No studies have been done to determine if the anthrax vaccine causes cancer, induces
genetic mutation, impairs fertility, or causes fetal harm.
NOTE: All six vaccinations must be given prior to exposure to anthrax to be effective and
must be done on the prescribed regimen.
| F-483 30M 8/90
Rev. 10/87 ANTHRAX VACCINE ADSORBED DESCRIPTION Anthrax Vaccine Adsorbed is a sterile product made from filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis which elaborates the protective antigen during the growth period. The cultures are grown in a synthetic liquid medium and the final product is prepared from sterile filtered culture fluid. The potency of this product is confirmed according tothe U.S. Food and Drug regulations (21 CFR 620.23): Additional Standards for Anthrax Vaccine Adsorbed. The final product contains no more than 2.4 mg aluminum hydroxide (equivalent to 0.83 mg aluminum) per 0.5 cc dose. Formaldehyde, in a final concentration not to exceed 0.02%, and benzethonium chloride, 0.0025%, are added as preservatives. CLINICAL PHARMACOLOGY Antrax Vaccine Adsorbed is used in man to promote increased resistance to Bacillus anthracis by active immunization (1,2). INDICATIONS AND USAGE Immunization with Anthrax Vaccine Adsorbed is recommended for individuals who
may come in contact with animal products such as hides, hair, or bones which come from
antrax endemic areas and may be contaminated with Bacillus anthracis spores;
and for individuals engaged in diagnostic or investigational activities which may bring
them into contact with B. anthracis spores (1-5). It is also
recommended for high risk persons such as veterinarians and others handling potentially
infected animals. Since the risk of exposure to anthrax infection in the general
population is slight, routine immunization is not recommended. CONTRAINDICATIONS A history of a severe reaction to a previous dose of anthrax vaccine is a
contraindication to immunization with this vaccine. |
WARNINGS 1. Any acute respiratory disease or other active infection is
generally considered to be adequate reason for deferring an injection. PRECAUTIONS 1. General: Epinephrine solution, 1:1000, should always be
available for immediate use in case an anaphylactic reaction should occur, even though
such reactions are rare. ADVERSE REACTIONS Local Reactions: Mild local reactions occur in approximately thirty per cent of
recipients and consist of a small ring of erythema, 1-2 cm in diameter, plus slight local
tenderness(1). This reaction usually occurs within 24 hours and begins to subside by 48
hours. Occasionally, the erythema increases to 3 to 5 cm in diameter.Local reactions tend
to increase in severity by the 5th injection and then may decrease in severity with
subsequent doses. |
| These may be pruritic. Subcutaneous nodules may occur at the
injection site and persist for several weeks in a few persons. A moderate local reaction
can occur if the vaccine is given to anyone with a past history of anthrax infection. More severe local reactions are less frequent and consist of extensive edema of the forearm in addition to the local inflammatory reaction. All local reactions have been reversible. Systemic Reactions: Systemic reactions which occur in fewer than 0.2 per cent of recipients have been characterized by malaise and lassitude. Chills and fever have been reported in only a few cases. In such instances, immunization should be discontinued. DOSAGE AND ADMINISTRATION Dosage Primary immunization consists of three subcutaneous injections, 0.5
mL each, given at 6, 12, and 18 months(1). Administration 1. Use a separate sterile needle and syringe for eachpatient to avoid
transmission of viral hepatitis and other infectious agents. |
HOW SUPPLIED Anthrax Vaccine Adsorbed is supplied in 5 mL vials containing 10 doses each. STORAGE THIS PRODUCT SHOULD BE STORED AT AT 2 TO 8 deg C (35.6 to 46.4 deg F). Do not freeze. Donot use after the expiration date given on the package. REFERENCES 1. Brachman, P. S., et. al. Field Evaluation of a Human Anthrax Vaccine.
Amer. J. Pub. Health, 52:632-645 (1962). . Manufactured by
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