Anthrax Facts has 5 main parts:
Anthrax Vaccine Facts
The Government Doesn't Want You to Know
1. According to the FDA product information leaflet (see below), NO scientific studies have been performed on the Anthrax Vaccine to determine if it causes cancer.
2. According to the FDA product information leaflet (see below), NO scientific studies have been performed on the Anthrax Vaccine to determine if it has any effect on fertility. This applies to both males and females. It is NOT known if this drug will effect your fertility or, if successful in conceiving, the fetus.
3. According to the FDA product information leaflet (see below), NO scientific studies have been performed on the Anthrax Vaccine to determine if it will protect you from inhaled anthrax spores.
4. According to the U. S. Army Medical Research Institute of Infectious Diseases (see the USAMRIID web site), there is NO scientific evidence to suggest that this vaccine will protect you from aerosolized anthrax.
5. A principal chemical component of the Anthrax Vaccine, formaldehyde, is not approved for human consumption according to the U. S. Government Material Data Safety Sheet.
6. A principal chemical component of the Anthrax Vaccine, benzethonium chloride, has not been evaluated for human consumption according to the U. S. Government.
7. The only facility licensed to produce the Anthrax Vaccine has been cited by the FDA for quality control problems. A summary of the findings appears below.
8. On March 3 1998, Secretary Cohen mandated (Sec Def Briefing No. 094-98) "supplemental testing, consistent with Food and Drug Administration standards, to assure sterility, safety, potency and purity of the vaccine," before further immunizations take place. These tests were ordered because the lab was having quality control problems. These tests did NOT further evaluate the vaccine to see if it causes cancer or impairs fertility, they only assured the vaccine met the FDA approved guidelines.
9. Most physicians know very little about the vaccine, other than what they are told by the government in preparation for implementation of this program.
10. There are a number of common reasons NOT to take the vaccine. Read the product information leaflet and talk to your civilian doctor.
10 Questions To Ask Your Doctor
Before You Take The Anthrax Vaccine
You might want to print this page as well as the transcribed anthrax vaccine advisory leaflet.
1. Can you show me the original Anthrax Vaccine product advisory leaflet that comes in the box with the vaccine?
2. Have you read and do you clearly understand everything in the vaccine's product advisory leaflet and as well as the cited references?
3. In the product advisory leaflet's paragraph labeled REFERENCES, it says, "These recommendations are prepared by the Michigan Department of Public Health only for the guidance of the physician. They do not replace the experience and judgement of the physician, who should be familiar with the pertinent medical literature before administering any biologic product." Can you summarize your recent readings on the vaccine and explain any new developments?
4. Can you explain the remarks in advisory leaflet section labeled PRECAUTIONS?
5. Could you summarize the studies performed on the anthrax vaccine's potential carcinogenic effects?
6. The vaccine's advisory leaflet says in the paragraph labeled PRECAUTIONS, the vaccine might affect reproduction capacity. Can you summarize the studies performed on the vaccines potential effect on fertility and explain how the vaccine might effect me (male or female)?
7. The advisory leaflet says nothing about the vaccine's ability to protect me from inhaled exposure to the anthrax bacteria. Can you summarize the studies which support the theory this vaccine will protect me against that threat?
8. Can you summarize your understanding of anthrax and it's use as a weapon?
9. Do you feel the long term effects of the Anthrax Vaccine are clearly understood by the medial, scientific and political communities?
10. Have you personally completed the 18 month course of shots which constitute the FDA approved anthrax vaccination program (why or why not)?
Bonus Question (4 July 98): On March 3 1998, Secretary Cohen mandated (Sec Def Briefing No. 094-98) "supplemental testing, consistent with Food and Drug Administration standards, to assure sterility, safety, potency and purity of the vaccine," before further immunizations take place. May I review the unedited results of these additional tests before receiving the vaccine?
Editors Note: I want you to make an informed decision about taking the Anthrax Vaccine. After weeks of head-butting, I finally got a copy of the FDA Product Information Leaflet which, by law, must accompany the injectionable vaccine. The EXACT, VERBATIM text of the leaflet follows
Page 1 of leaflet
Anthrax Vaccine is supplied in 5 mL vials containing 10 doses each.
THIS PRODUCT SHOULD BE STORED AT 2 TO 8º C (35.6 to 46.4ºF). Do not freeze. Do not use after the expiration date given on the package.
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 Anthrax. 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 on 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. They do not replace the experience and judgement of the physician, who should be familiar with the pertinent medical literature before administering any biologic product.
MICHIGAN DEPARTMENT OF PUBLIC HEALTH
Lansing, Michigan 48909
U. S. License No. 99
Auth.: Act 368, 1978
F-483 125M 7/96 Rev 10/87
ANTHRAX VACCINE ADSORBED
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 the sterile filtered culture fluid. The potency of this product is confirmed according to the U. S. Food and Drug regulations (21 CFR 620.23): Additional Standards for Anthrax Vaccine Adsorbed. The final product contains no more than 2.4mg 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.
Anthrax 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 anthrax 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 will not protect against infection.
A history of severe reaction to a previous dose of anthrax vaccine is a contraindication to immunization with this vaccine.
Page 2 of leaflet
1. Any acute respiratory disease or other active infection is generally considered to be adequate reasons for deferring an injection.
2. Persons receiving coritco-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 long termed, an extra dose vaccine should be given a month or more after therapy is discontinued.
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 effect 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.
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 forarm 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 cases, immunization should be discontinued.
DOSAGE AND ADMINISTRATION
Primary immunization consists of three subcutaneous injections, 0.5mL each, given 2 weeks apart followed by three additional subcutaneous injections, 0.5mL 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.
1. Use a separate sterile needle and syringe for each patient to avoid transmission of viral hepatitis and other infections 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 given 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 vaccine.
8. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
End of product information leaflet
Summary of the 2/20/98 FDA Inspection
on the Michigan Biological Products Institute
[All Anthrax Vaccine produced for U. S. use is manufactured by this lab. The FDA recently issued a notice of intent to revoke the license of the labs governing body, a research arm of the University of Michigan.]
Summary of the 2/20/98 FDA Inspection Report on the MBPI [Michigan Biologic Products Institute, Lansing, Michigan], Meryl Nass, M.D. May 19, 1998
Essentially all the issues in the report have to do with grossly inadequate quality control. However, it appears that the production process was carried out in a particularly cavalier manner, as if the product would never be used on human beings, and was being manufactured solely to meet production quotas. The issue of how MBPI was allowed to carry on despite repeat violations of standards over many years is another story; here I am trying only to list in a brief but comprehensible manner the issues enumerated in the FDA's report.
1. MBPI did not test the suitability of their own
procedures, nor validate them:
a. storage times for bulk anthrax preparations in tanks lasted from a week to 4 months, before filling of containers;
b. mixing times not standardized; the product settles quickly in the tank and homogeneity of the suspension has not been demonstrated;
c. testing for contamination was sporadic;
d. the sporicide used was not validated;
e. sublots are held for 3 years or longer before being used in a lot (Stability data to support this hold time do not exist);
f. the filters used to harvest the vaccine were neither validated nor integrity tested prior to August, 1997;
g. validation of microbial retention by the filters was performed using inappropriate media, used for production of tetanus, not anthrax;
h. there is no validation of cleaning for the equipment which is in contact with the vaccine materials;
i. "there is no documentation of testing for container/closure integrity or container/closure compatibility for periods up to seven years."
2. Inadequate analytical methods:
a. the reference standard used for potency testing was from a lot produced in 1991;
b. "the analytical methods for determination of *** and *** in anthrax vaccine are not validated with respect to accuracy, precision, linearity, specificity and limit of detection;"
c. "potency testing of anthrax vaccine requires either testing one finished product vial, an aliquot from the formulated bulk tank, or a pilot bulk sample. There are no data demonstrating that these samples are representative of the lot."
3. Lack of written operating procedures:
a. for examination, rejection and disposition of anthrax sublots;
b. for redating expired vaccine to extend the expiration period; Example: Lot FAV023 was tested twice for redating (presumably potency) and twice for stability in 1997 and failed all tests. It was scheduled to be retested for redating on 4/21/98.
c. for time limits for which product can be exposed to room temperature;
d. "The firm's SOP (standard operating procedure) for handling manufacturing deviations/departures does not address when a lot should be monitored on stability."
4. Inadequate testing procedures:
a.sublots are tested when produced, but not retested prior to formulation, which may occur several years later;
b. Test results are reported as "unsatisfactory" or "no test", indicating an invalid test, apparently in addition to frank "failed" results. What do these results mean, and are lots with these designations used or retested?
5. Quarantined materials (what precisely is meant by
quarantined? Failed testing?
a. These are held for extended periods; examples are given of a sublot quarantined in 1992 which was held, and only destroyed in 1997 due to mold contamination;
b. Other sublots failed potency tests but are still held in quarantine.
6. Expiration dates:
a. "expiration dates are assigned based on the latest valid potency test. There is no correlation between this date and formulation of bulk or filling of the finished product;"
b. expired vaccine lots are "redated", based only on another potency test. There is no analytic testing identifying and demonstrating the absence of degradants;
c. "there are no expiration dates for the working spore concentrations (virulent or avirulent strains)."
7. Labelling issues:
a. anthrax lots approved by CBER for redating are given alternate lot numbers to indicate they have been redated. However, MBPI has used the original lot numbers for labelling, thus concealing the fact that the lot was "redated;"
b. "for anthrax vaccine lots #FAV008 through #FAV016, the firm unpacked the vials from the cartons and removed the labels...the firm does not have documentation of performing reconciliation of the vials before and after this operation." [Does this mean the labels were removed and replaced with new labels and reused? Why?]
8. Stability testing:
a. testing for stability only began in 1997;
b. "stability testing consists only of performing release tests at various intervals;" (What is a release test?)
c. stability testing does not address product degradation;
d. "there is no justification for putting lots manufactured as early as 1991 into the stability program;"
e. "the firm does not have a system in place to investigate and report stability failures."
9. Use of vaccine lots that failed testing. Several
a. lot FAV011 was filled on 10/17/91, redated in 1994, and again retested in 1997. Its potency rating was 11 ppm, below the lower accepted limit, but the lot was not rejected nor placed in quarantine;
b. lot FAV023 was filled on 12/13/94. It failed 3 potency tests in 1997, yet was retested for a 4th time in 10/97, where it was listed as passing by 0.01. There was no investigation into the earlier results or justification for the additional testing;
c. "lot FAV016 had 6570 vials rejected due to particulates during post filling inspection. These particulates were not identified, nor was an investigation conducted. The batch was released;"
d. sublots AV383 and AV390 failed original sterility tests, but passed on repeat testing. It appears that such sublots were included in bulk lots. Part of the report is missing here.
a. after harvest from the holding tank, including transfer of sublots to different buildings, samples were not placed on media "to validate aseptic manufacturing after harvest;"
b. "lot FAV035 had 409 vials rejected for faulty closure during post filling inspection; There was no investigation conducted."
c. When environmental monitoring indicates that environmental action limits are exceeded, the firm's procedures do not require that additional cleaning and increased sampling be performed.
11. Missing sections of the report:
a. my copy lacks part of section 9 until section 16; Sections 20 through 25 are completely whited out. Elsewhere, many words and names are whited out as well.
Things you can do to force the government
responsibility for the possible negative effects of the vaccine.
If you have less than 18 months remaining on active duty
--Insist on being exempted from the vaccine
--Failing that, insist the government sign a written agreement to incur all travel expenses required to give you the FULL 18 month vaccination series. The ONLY way the drug is FDA approved is if it is given according to the 18 month schedule.
- Insist the government provide a written statement of purpose for administering the vaccine.
- Insist your case be reviewed by a medical review board prior to being punished for "failure to obey a lawful written order."
- Consider objecting to the vaccine on religious grounds
- Insist the government sign a written statement acknowledging the drug has not been tested for its carcinogenic effects or potential impairment of fertility.
- Insist the government sign a written statement acknowledging the drug has not been tested for its ability to protect you from aerosolized (inhaled) anthrax exposure. (This is the primary reason DoD says you need the vaccine. In that respect, the vaccine is experimental since its ability to protect you has not been proven.)
- Insist the government sign a written statement agreeing to pay for all medical expenses relating to any future instance of cancer you may develop.
- Insist the government sign a written statement agreeing to pay for all medical expenses relating to any future instance of infertility you may experience.
- Write your Congressman or Senator.
--find your Congressman or Senator quickly at http://www.hoboes.com/html/Politics/electednet/
- Forward this to everyone you know in the military!
Also See Anthrax Waiver info: Click Here
Gulf War Vets Home Page.