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Safety | | |
1) Is the anthrax vaccine safe? | | |
Yes, this vaccine has been safely administered in the U.S. to at-risk veterinary and laboratory workers, livestock handlers, and servicemembers since licensure by the Food & Drug Administration (FDA) in 1970. The FDA certifies the safety and efficacy of all pharmaceuticals (medications) used in the U.S. One of FDA’s primary missions is to ensure that pharmaceuticals released for use by the American public are tested for both safety and efficacy. Like all vaccines, anthrax vaccine may cause soreness, redness, itching, swelling, and lumps at the injection site. About 30% of men and 60% of women report these local reactions, but they usually last only a short while. Lumps can persist a few weeks, but eventually disappear. Injection-site problems occur about twice as often among women. For both genders, between 1% and 5% report reactions of 1 to 5 inches in diameter. Larger reactions occur in about one in a hundred vaccine recipients. Beyond the injection site, from 5% up to 35% will notice muscle aches, joint aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise, or related symptoms. Again, these symptoms usually go away after a few days. Over-the-counter medications before or after the anthrax vaccine may help reduce bothersome symptoms. Like all vaccines, most adverse events are minor and temporary. Serious events, such as those requiring hospitalization, are rare. They happen about once per 200,000 doses. Severe allergic reactions can occur after any vaccination, less than once per 100,000 doses. Anthrax vaccine is as safe as other vaccines. Like other vaccines, deaths have been reported rarely after anthrax vaccination. Each of these cases is carefully reviewed by CDC, FDA, and DoD, to make vaccinations as safe as possible. For independent information about vaccines and vaccine safety see: Centers for Disease Control & Prevention's National Immunization Program: http://www.cdc.gov/nip | | |
2) What about long-term side effects? | | |
There are no known long-term side effects to anthrax vaccine. At Fort Detrick, more than 1,500 laboratory workers followed for up to 10 to 20 or more years after receiving anthrax vaccine. Most of these workers received 150 to 200 vaccinations and skin tests; some received more than 300 such injections during their tenure at Fort Detrick. The first report of this group of vaccine recipients was published in the Bulletin of the Johns Hopkins Hospital in 1958. Two follow-up reports were printed in the Annals of Internal Medicine in 1965 and 1974. An updated manuscript is currently being finalized. These employees have been followed annually. None developed unexplained symptoms due to repeated doses of this or other vaccines they received. From this and other monitoring, no patterns of delayed side effects to anthrax vaccine have been found. Monitoring continues. An extension of this long-term study is underway to determine, in even greater detail, whether people who received multiple vaccines, including anthrax vaccine, during their past employment at Fort Detrick demonstrated any adverse health effects over the long term. A total of 570 study and control volunteers have been enrolled in this case-control study begun in 1996. All volunteers signed an informed-consent document. The study methods include a 9-page health history questionnaire, extensive blood tests and urinalysis. The questionnaire queries mental and physical conditions of progeny as well as the health of volunteers. Study end points include symptoms, symptom complexes (including the complex of symptoms reported by veterans of the Persian Gulf War), diseases, and abnormal laboratory and urine tests. Study subjects will be compared to two to three race-, gender-, and age-matched control subjects to determine if any long-term medical effects exist among this unique group of study subjects. Analysis of the data from the extensive health history questionnaire and numerous laboratory tests is currently in progress. An October 2004 review of over 716,000 active-duty service members discharge rates shows anthrax vaccination does not increase risk of disability. Overall, the disability evaluation rate in the Army was very low for the 4.25 years covered by this study, and there appeared to be no effect of exposure to anthrax vaccine on the risk of disability evaluation. | | |
3) Is there a requirement for long-term follow-up after the anthrax vaccine is
administered?
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No. Like other FDA-licensed products, the anthrax vaccine does not require follow-up monitoring of healthy vaccine recipients. Nonetheless, the DoD has already conducted such studies and is conducting more. No data collected to date shows any patterns of adverse events developing years after people have been vaccinated with anthrax vaccine or any other vaccine. | | |
4) Is this an experimental vaccine? | | |
No, the anthrax vaccine has been FDA licensed since 1970. License No. 99 was issued on November 4, 1970. It is neither "experimental" nor "investigational." Since 1970, this vaccine has been administered to people at risk for anthrax exposures including certain veterinary and laboratory workers and civilians who work with animal products. FDA officials reported that about 68,000 doses of anthrax vaccine were distributed in the United States between 1974 and 1989. Since licensure in 1970, the U.S. Army purchased this vaccine for use by at-risk laboratory workers, and it was used during the Gulf War (approximately 150,000 recipients) to vaccinate U.S. forces against Iraq’s production of biological weapons. The military currently vaccinates people working in at-risk jobs and some 3,000 personnel assigned to special operations units, the Army Technical Escort Unit and the Marine Corps Chemical-Biological Incident Response Force (C-BIRF). The Centers for Disease Control and Prevention’s offer of anthrax vaccine for Congressional and U.S. Postal Service workers used anthrax vaccine for “post-exposure treatment” in three doses. This is not a Food and Drug Administration-licensed use of the vaccine, although the vaccine itself was, and is, licensed. Therefore, in that case (post-exposure), the vaccine was administered under an “investigational new drug” protocol, with informed consent. The Department of Defense’s use of anthrax vaccine in the Anthrax Vaccine Immunization Program for pre-exposure prevention is consistent with the Food and Drug Administration-licensed use of the vaccine. When Emergent BioSolutions bought the facilities of the Michigan Biologic Products Institute, License No. 1260 was substituted for License No. 99. | | |
5) What about sterility or impairment of fertility? | | |
In nearly 30 years of licensed use, there is no evidence of any sterility or fertility impairment from anthrax vaccine. Regarding reproductive health, the Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices states, "there is no convincing risk from vaccinating pregnant women with inactivated virus or bacterial toxoids."
In the March 27, 2002, issue of the Journal of American Medical Association, two Army physicians published their peer-reviewed findings that women get pregnant at the same rate, whether anthrax-vaccinated or unvaccinated. These physicians from Fort Stewart, Georgia, also showed that women deliver offspring at the same rate, whether anthrax-vaccinated or unvaccinated. The Fort Stewart study found no difference in birth defect rates, but the study may have been too small to detect small differences. [Wiesen AR, Littell CT. Relationship between pre-pregnancy anthrax vaccination and pregnancy and birth outcomes among U.S. Army women. Journal of the American Medical Association (JAMA) 2002; 287:1556-60. http://jama.ama-assn.org/content/vol287/issue12/index.dtl.
Preliminary data from the Naval Health Research Center raised a tentative signal that there may be an association with an increased rate of birth defects if vaccinated in the first trimester of pregnancy. This signal is being investigated thoroughly, to determine which of several explanations for the signal is most likely.
Long-standing Defense policy is to defer routine vaccinations in women until after pregnancy. This policy has always applied to anthrax vaccine. Women are asked if they are pregnant before vaccination. Women who are not sure are offered pregnancy tests.
Data about anthrax vaccination was obtained from men at time of oocyte and sperm retrieval. Researchers assessed characteristics of male gametes, including 254 vaccinated men and 791 unvaccinated men. The two groups were comparable for semen concentration (million sperm per milliliter), sperm motility (movement), sperm morphology (shape), need for intracytoplasmic sperm injection, and rate of fertilization of mature oocytes, embryo transfer, and clinical pregnancy. A diagnosis of male-factor infertility was less common in anthrax-vaccinated men than in unvaccinated men. The researchers concluded that anthrax vaccination of men did not impair semen parameters, fertilization rate, embryo quality, or clinical pregnancy rates.
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6) Are there any other groups or agencies besides DoD that advocate the use of the
anthrax vaccine? | | |
In addition to the Department of Defense, other agencies and groups advocate or support the use of the anthrax vaccine. The Food & Drug Administration licensed the anthrax vaccine in 1970. The Centers for Disease Control & Prevention, the World Health Organization, the Defense Health Board, and many other respected public health organizations support use for people at risk or exposed to Bacillus anthracis. Information about the AVIP is available on the Internet (a variety of DoD web sites as well as the Centers for Disease Control & Prevention (www.cdc.gov) and the Food & Drug Administration web sites), which includes facts about the anthrax vaccine, history, side effects, purpose for immunizations and more. [See the Q&A page on independent scientific reviews.] Evidence for the efficacy of the anthrax vaccine is sufficient for it to be included in standard medical reference books in the United States and around the world. These references include: Control of Communicable Diseases Manual, 17th ed. James Chin, ed. "An official report of the American Public Health Association," Washington, DC, 2000.
Guide for Adult Immunization, 3rd ed, Philadelphia: American College of Physicians, 1994.
Immunization Against Infectious Disease. Her Majesty’s Stationery Office, London: British Joint Committee on Vaccination and Immunization, 1996. Report of the Committee on Infectious Diseases, 26th edition, Elk Grove Village, IL: American Academy of Pediatrics, 2003.
ImmunoFacts: Vaccines & Immunologic Drugs. Saint Louis: Facts and Comparisons, Inc., 2006.
Merck Manual on Drugs & Therapeutics. West Point, PA: Merck and Company, 1999.
Anthrax vaccine is a prominent part of the World Health Organization’s 1998 Guidelines for the Surveillance and Control of Anthrax in Humans and Animals.
Similarly, anthrax vaccination is specifically endorsed in the Working Group on Civilian Bio-defense position paper on preparedness against anthrax (Inglesby, et al. Anthrax as a Biological Weapon, 2002.
Journal of the American Medical Association (JAMA) 2002;287:2236- 52).
The U.S. Department of Agriculture lists anthrax vaccine as a condition of employment for personnel of the Animal & Plant Health Inspection Service (APHIS), if potentially exposed on the job. | | |
7) Is the Department of Defense continuing to research safety aspects of the anthrax
vaccine?
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Thirty (30) years of experience with anthrax vaccine in the United States suggests it has a similar side effect profile compared to other commonly used vaccines. Nonetheless, the Department of Defense continues to monitor the safety of the anthrax vaccine during program execution. As the National Academy of Sciences pointed out, the most scientifically powerful way of assessing vaccine safety is by comparing and contrasting people vaccinated and unvaccinated against anthrax. In addition, DoD scientists are currently conducting more long-term research and designing yet more studies. In designing these studies, we will draw from the accumulated experience of some of the nation’s best vaccine researchers at CDC and FDA. One of the methods used is a surveillance technique used by CDC in post-marketing studies: large, linked databases. DoD uses the large, linked database approach in its long-term research efforts through access to its immunization tracking programs database and though the medical databases maintained by the Defense Medical Surveillance System (DMSS). | | |
8) Is there any risk of cancer or mutagenesis (genetic mutations)? | | |
In nearly 30 years of use, there is no evidence that the anthrax vaccine causes cancer or mutagenesis. As with most other vaccines or other pharmaceuticals, studies regarding carcinogenesis or mutagenesis has not been performed with anthrax vaccine. Such studies have not been performed, in large part, because in over 200 years of administering vaccines to humans, no vaccine has ever been shown to cause cancer or genetic mutations. | | |
9) I don't have a spleen. Can I still get vaccinated? | | |
Yes, you may receive the anthrax vaccine if your spleen was removed in surgery or if your spleen no longer works properly. Several vaccines are specifically recommended for people without a spleen (asplenic people), to improve the body's defense against infections. In general, inactivated or killed vaccines (including anthrax vaccine) are recommended for people without spleens. In many cases, such vaccines may be life-saving by preventing overwhelming infection. The American College of Physicians (ACP) specifically names anthrax vaccine in its 1994 guidelines for people at risk of exposure to this bacterium. People without a spleen should get some live vaccines and avoid others. Spleens help people fight infections. People who do not have a spleen have a hard time protecting themselves against bacteria. Without a spleen, people are at risk of severe bacteremia (infection in the blood) from many types of bacteria. Some people lose their spleens during surgery to repair abdominal injuries suffered during accidents or their spleen is removed to help them respond to certain kinds of cancer. Certain diseases, especially sickle cell disease, destroy the spleen, while other people may be born
without a spleen. According to the American College of Physicians (ACP), people without spleens or people whose spleens don't work properly should be vaccinated against the following diseases, if they are susceptible to them: Tetanus, diphtheria, pneumococcal, Haemophilus influenzae type b (Hib), meningococcal, and influenza. These people should be vaccinated against anthrax, cholera, hepatitis B, measles, mumps, plague, poliovirus (injectable vaccine), rabies, rubella, and typhoid fever (injectable vaccine), if these vaccines are needed. The ACP concludes by saying “In addition, the importance of anti-malarial prophylaxis must be emphasized for those planning foreign travel to areas where malaria occurs." (Guide for Adult Immunization, 3rd ed. Philadelphia: 1994) The American Academy of Pediatrics and the CDC’s Advisory Committee on Immunization Practices provide similar recommendations on vaccines for persons with surgical or functional asplenia.
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10) Should people with lupus (SLE) get vaccinated? | | |
People who have been diagnosed with lupus should talk with their physician about whether or not they should be vaccinated, considering the state of their disease, the medications they take, and their personal risk for specific infections. Several medical studies have shown that people with lupus can be safely and effectively vaccinated against influenza, hepatitis B, pneumococcal disease and other diseases that would pose a significant risk if they were infected. For military personnel with lupus, providers are authorized to grant medical exemptions according to the patient's specific situation. Medical specialists can advise how to get the best benefit from vaccination in such circumstances. | | |
11) What information about potential risks of vaccination will DoD provide people who will be vaccinated against anthrax? | | |
DoD will ensure potential vaccine recipients receive the most current educational trifold brochure available . An Individual’s Briefing will be available at all immunization sites. Potential vaccine recipients will be educated about the threat of anthrax and the benefits and risks of vaccination. | | |
12) How will the side effects of anthrax vaccinations be monitored? | | |
DoD will continue its enhanced safety surveillance program, which features:
• Encouraging healthcare workers and vaccine recipients to report adverse events to the Vaccine Adverse Events Reporting System (VAERS, www.vaers.hhs.gov)
• Systematic monitoring of the health of recipients of anthrax vaccine adsorbed (e.g., cohort studies using the Defense Medical Surveillance System databases). | | |
13) How will DoD track who receives anthrax vaccinations? | | |
DoD will track anthrax vaccinations through Service-specific automated immunization tracking systems and the DEERS central repository. Where electronic immunization tracking is unavailable all vaccinations will be recorded in the individual health record and “yellow shot card” (PHS-731) (if provided). | | |
14) What compensation is available for individuals who claim injury from anthrax vaccine? | | |
Established military and civilian worker’s programs provide compensation for injuries or illnesses resulting from military service or civilian job requirements. | | |
15) For More Information: | | |
Advisory Committee on Immunization Practices. General recommendations on immunization. MMWR-Morbidity & Mortality Weekly Report 2002;51(RR-2):1-35. ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr5102.pdf
American College of Obstetricians & Gynecologists, Committee Opinion, Immunization During Pregnancy, 2003;282:1-6. http://www.acog.org/from_home/publications/misc/bco282.pdf
Brachman PS, Friedlander AM, Grabenstein JD. Anthrax. In: Plotkin SA, Orenstein WA, ed. Vaccines, 3rd ed. Philadelphia: W. B. Saunders, 2003.
Brachman PS, Gold H, Plotkin SA, Fekety FR, Werrin M, Ingraham NR. Field evaluation of a human anthrax vaccine. American Journal of Public Health 1962;52:432-45. http://www.anthrax.mil/documents/338field_eval.pdf
Advisory Committee on Immunization Practices. Use of anthrax vaccine in the United States. MMWR-Morbidity & Mortality Weekly Report 2000;49(RR-15):1-20. http://www.cdc.gov/mmwr/PDF/rr/rr4915.pdf
Catherino WH, Levi A, Leondires M, Segars JH, Alvero R, McKeeby J. Fertility & Sterility Abstracts Vol. 78, No. 3, Suppl. 1, September 2002, pages S108-S109. http://www.vaccines.mil/documents/library/Fertility&Sterility.pdf
Christopher GW, Cieslak TJ, Pavlin JA, Eitzen EM Jr. Biological warfare: A historical perspective. Journal of the American Medical Association 1997;278(Aug 6):412-17. http://jama.amaassn.org/cgi/content/short/278/5/412
Food & Drug Administration. Biological products; Bacterial vaccines and toxoids; Implementation of efficacy review. Federal Register 1985;50:51002-117. http://www.anthrax.mil/documents/205Fed_Reg.pdf
Hambleton P, Carman JA, Melling J. Anthrax: The disease in relation to vaccines. Vaccine 1984;2:125-32.
Inglesby TV, O'Toole T, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Friedlander AM, Gerberding J, Hauer J, Hughes J, McDade J, Osterholm MT, , Parker G, Perl TM, Russell PK, Tonat K, Working Group on Civilian Biodefense. Anthrax as a biological weapon, 2002: Updated Recommendations for Management. Journal of the American Medical Association 2002;287:2236- 52. http://jama.ama-assn.org/cgi/reprint/287/17/2236.pdf
Peeler RN, Cluff LE, Trever RW. Hyper-immunization of man. Bulletin of the Johns Hopkins Hospital 1958;103:183-98. Peeler RN, Kadull PJ, Cluff LE. Intensive immunization of man: Evaluation of possible adverse consequences. Annals of Internal Medicine 1965;63:44-57.
Singleton JA, Lloyd JC, Mootrey GT, Salive ME, Chen RT, VAERS Working Group. An overview of the vaccine adverse event reported system (VAERS) as a surveillance system. Vaccine 1999;17:2908-17. Turnbull PCB. Guidelines for the Surveillance and Control of Anthrax in Humans and Animals, 3rd ed., WHO Report WHO/EMC/ZDI/98.6. http://www.who.int/emcdocuments/zoonoses/whoemczdi986c.html
White CS III, Adler WH, McGann VG. Repeated immunization: Possible adverse effects: Reevaluation of human subjects at 25 years. Annals of Internal Medicine 1974;81:594 600. http://www.vaccines.mil/documents/library/Repeated.pdf
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