United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office National Security and International Affairs Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1999-07-21 monographic deposited born digital 15 p. GA 1.13:T-NSIAD-99-226 https://www.govinfo.gov/app/details/GAOREPORTS-T-NSIAD-99-226 P0b002ee180394385 f:ns99226t DGPO 2010-08-12 2011-03-28 GAOREPORTS-T-NSIAD-99-226 machine generated eng fdlp REPORT GAOREPORTS-T-NSIAD-99-226 T-NSIAD-99-226 Immunization services Biological warfare Chemical warfare Data collection Safety standards Public health research Military personnel Product safety CDC/FDA Vaccine Adverse Events Reporting System DOD Anthrax Immunization Program Testimony NSIAD Pursuant to a congressional request, GAO discussed the results of its work on the anthrax vaccine, focusing on: (1) the extent to which data support the need for six initial shots and an annual booster of the anthrax vaccine; (2) the relative merits and weaknesses of a passive surveillance system in determining adverse events; (3) the available data on differences in adverse reaction rates between men and women receiving the anthrax vaccine; and (4) the disadvantages of the vaccine and the status of federal efforts to develop an improved anthrax vaccine.<p/>GAO noted that: (1) no studies have been done to determine the optimum number of doses of the anthrax vaccine; (2) a study done during the early 1950s showed that animals could be protected against cutaneous anthrax using a three-dose schedule; (3) however, the number of doses was increased to six when three people who had received three doses of the vaccine were infected after exposure to anthrax; (4) in a study of the vaccine's human efficacy published in 1962, a six-dose schedule was used, and the researchers concluded that the vaccine provided protection against cutaneous exposure to anthrax; (5) in 1998, the manufacturer of the vaccine submitted a Food and Drug Administration (FDA) application to determine whether the number of shots in the initial schedule could be reduced from six to five; (6) although annual boosters are given, the need for this frequency and the amount of the booster dose has also not been evaluated; (7) Department of Defense (DOD) submits data on adverse events associated with the anthrax vaccine to the Vaccine Adverse Events Reporting System; (8) this system has several advantages; (9) it alerts FDA and Centers for Disease Control and Prevention (CDC) to previously unreported or unexpected increases in reported adverse events; (10) it is also a relatively affordable way to supplement the data collected on vaccines before they are licensed; (11) however, it is a passive surveillance system, which means that FDA and CDC must rely on vaccine recipients or their health care providers to report any adverse events after receiving the vaccine; studies show that adverse events are reported significantly less than they would be in an active surveillance system; (12) DOD has conducted three efforts to actively collect data on adverse reactions after servicemembers received the anthrax vaccine; (13) data from these efforts show that women reported twice the rate of adverse reactions than men for both local and systemic reactions; (14) a higher proportion of women than men reported making an outpatient medical visit after a vaccination, and more than twice the percentage of women reported that they missed one or more duty shifts after their vaccinations than did men; (15) the anthrax vaccine has several disadvantages; (16) the amount of protective antigen in the vaccine cannot be precisely measured, and it varies from lot to lot; and (17) also, the requirement for a six-dose schedule and annual booster shots, rather than a smaller number of doses, complicates the logistics of inoculating all of DOD's troops and increases the cost of the vaccine program. https://www.govinfo.gov/content/pkg/GAOREPORTS-T-NSIAD-99-226/html/GAOREPORTS-T-NSIAD-99-226.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-T-NSIAD-99-226/pdf/GAOREPORTS-T-NSIAD-99-226.pdf GAO/T-NSIAD-99-226 https://www.govinfo.gov/app/details/GAOREPORTS-T-NSIAD-99-226 Testimony GAO/T-NSIAD-99-226; Medical Readiness: Issues Concerning the Anthrax Vaccine; Immunization services Biological warfare Chemical warfare Data collection Safety standards Public health research Military personnel Product safety CDC/FDA Vaccine Adverse Events Reporting System DOD Anthrax Immunization Program