Notes from Joyce on Anthrax Vaccine Safety

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Notes from Joyce on Anthrax Vaccine Safety

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.

Actual Warning Sheet from Anthrax Vaccine

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.
If a person has not previously been immunized against anthrax, injection of this product following exposure to anthrax bacilli wil not protect against infection.

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.
2. Persons recieving cortico-steroid therapy or other agents which would tend to depress the immune response may not be adequately immunized with the dosage schedule recommended. If the therapy is short termed, immunization should be delayed. If the therapy is long termed, an extra dose of vaccine should be given a month or more after therapy is discontinued.

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.
2. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies have not been performed to ascertain whether Anthrax Vaccine Adsorbed has carcinogenic action, or any effect on fertility.
3. Pregnancy: PREGNANCY CATEGORY C. ANTHRAX VACCINE ADSORBED Animal reproduction studies have not been conducted with Anthrax Vaccine Adsorbed. It is also not known whether Anthrax Vaccine Adsorbed can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Anthrax Vaccine Adsorbed should be given to pregnant women only if clearly needed.
4. Pediatric Use: This antigen should be administered only to healthy men and women from 18 to 65 years of age because investigations to date have been conducted exclusively in that population.

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.
Moderate local reactions which occur in 4 per cent of recipients of a second injection are defined by an inflammatory reaction greater than 5 cm diameter.

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).
If immunity is to be maintained, subsequent booster injections of 0.5 mL of anthrax vaccine at one year intervals are recommended.

Administration

1. Use a separate sterile needle and syringe for eachpatient to avoid transmission of viral hepatitis and other infectious agents.
2. Shake the bottle thoroughly to ensure that the suspension is homogeneous during withdrawal. The Rubber stopper should be treated with an appropriate disinfectant and allowed to dry before inserting the needle.
3. This preparation must be give subcutaneously after cleansing the overlying skin with an antiseptic.
4. Follow the usual precautions to avoid intravenous injection.
5. After withdrawing the needle, the injection site may be massaged briefly and gently to promote dispersal of the vaccine.
6. The same site should not be used for more than one injection of this vaccine.
7. Do not syringe-mix with any other product.
8. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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).
2. Editorial: Vaccine Against Antrax. Brit. Med, j., 2:717-718(1965).
3. Advisory Committee for Immunization Practices. Adult Immunization, Morbidity and Mortality Report, 33(15):33-34, 1984.
4. Committee on Immunization, Guide for Adult Immunization, 1985, Amer. Col. Physicians, Philadelphia, PA (1985).
5. Report of Committee on Infectious Diseases, 19th Edition, Amer. Acad. Pediatrics, Evanston, IL (1982).

These recommendations are prepared by the Michigan Department of Public Health only for the guidance of the physician, who should be familiar with the recent pertinent medical literature before administering any biologic product

Manufactured by
MICHIGAN DEPARTMENT OF
PUBLIC HEALTH
Lansing, Michigan 48909
U.S. License No. 99

Auth.: Act 368, 1978

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ALL INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.