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 1999-10-12 monographic deposited born digital 14 p. GA 1.13:T-NSIAD-00-48 https://www.govinfo.gov/app/details/GAOREPORTS-T-NSIAD-00-48 P0b002ee1803a1569 f:ns00048t DGPO 2010-08-12 2011-03-28 GAOREPORTS-T-NSIAD-00-48 machine generated eng fdlp REPORT GAOREPORTS-T-NSIAD-00-48 T-NSIAD-00-48 Immunization programs Immunization services Safety standards Product evaluation Quality control Biological warfare Chemical warfare Military personnel Product safety DOD Anthrax Immunization Program CDC/FDA Vaccine Adverse Events Reporting System ****************************************************************** Testimony NSIAD Pursuant to a congressional request, GAO discussed the results of its ongoing examination of the safety and efficacy of the anthrax vaccine, focusing on the: (1) need for a six-shot regimen and annual booster shots; (2) long- and short-term safety of the vaccine; (3) efficacy of the vaccine; (4) extent to which problems the Food and Drug Administration (FDA) found in the vaccine production facility in Michigan could compromise the safety, efficacy, and quality of the vaccine; and (5) effects of the anthrax vaccine on children, pregnant women or lactating women.<p/>GAO noted that: (1) no studies have been done to determine the optimum number of doses of the anthrax vaccine; (2) although annual booster are given, the need for a six-shot regimen and annual booster shots have not been evaluated; (3) the long-term safety of the licensed vaccine has not been studied; (4) however, the Department of Defense (DOD) is designing studies to examine the vaccine's long-term effects; (5) data on the prevalence and duration of short-term reactions to the vaccine are limited but suggest that women experience a higher rate of adverse reactions than men do; (6) FDA's system for collecting data on adverse events associated with the vaccine, which DOD uses, relies on vaccine recipients or their health care providers to report adverse events; (7) the Brachman reported on 379 subjects that received this vaccine; (8) the study concluded that individual reactions to the vaccine were relatively minor; (9) about 35 percent had local reactions, a figure that varied during the inoculation series; (10) in addition to this study, some data was collected to support licensing of the vaccine but is of limited use because some participants had already received the earlier vaccine; (11) post-licensing data are limited because only a limited number of doses were distributed by the manufacturer from 1974 through 1989; (12) also, FDA did not establish its Vaccine Adverse Event Reporting System until 1990; (13) this system, which DOD uses, alerts FDA and the Centers for Disease Control (CDC) to increases in adverse events; (14) 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; (15) since DOD's mandatory inoculation program began in 1998, DOD has conducted two efforts to actively collect data on the short-term safety of the vaccine; (16) these data also allow one to examine gender differences in adverse reactions after servicemembers have received the anthrax vaccine; (17) according to the data gathered in both efforts, a higher proportion of females reported reactions to the anthrax vaccine than did their male counterparts; and (18) the anthrax vaccine is not intended to be administered to children, pregnant or lactating women, and consequently no studies have been conducted to determine the specific effects of administering the anthrax vaccine to these groups. https://www.govinfo.gov/content/pkg/GAOREPORTS-T-NSIAD-00-48/html/GAOREPORTS-T-NSIAD-00-48.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-T-NSIAD-00-48/pdf/GAOREPORTS-T-NSIAD-00-48.pdf GAO/T-NSIAD-00-48 https://www.govinfo.gov/app/details/GAOREPORTS-T-NSIAD-00-48 Testimony GAO/T-NSIAD-00-48; Anthrax Vaccine: Safety and Efficacy Issues; Immunization programs Immunization services Safety standards Product evaluation Quality control Biological warfare Chemical warfare Military personnel Product safety DOD Anthrax Immunization Program CDC/FDA Vaccine Adverse Events Reporting System ******************************************************************