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.
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:
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