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 1999-10-22 monographic deposited born digital 59 p. GA 1.13:NSIAD-00-36 https://www.govinfo.gov/app/details/GAOREPORTS-NSIAD-00-36 P0b002ee180374968 f:ns00036 DGPO 2010-08-12 2011-03-28 GAOREPORTS-NSIAD-00-36 machine generated eng fdlp REPORT GAOREPORTS-NSIAD-00-36 NSIAD-00-36 Immunization services Safety standards Data integrity Reporting requirements Biological warfare Defense procurement Military personnel Product safety Medical information systems Health hazards DOD Anthrax Immunization Program DOD Enrollment Eligibility Reporting System CDC/FDA Vaccine Adverse Events Reporting System DOD Composite Health Care System Letter Report NSIAD Pursuant to a congressional request, GAO reviewed the Department of Defense's (DOD) implementation of the anthrax vaccination program as it is currently structured, focusing on DOD's: (1) ability to maintain an adequate supply of anthrax vaccine for its immunization schedule; (2) system for recording and tracking servicemembers' vaccinations; and (3) steps to educate servicemembers about the program.<p/>GAO noted that: (1) as of July 1999, DOD had given about 1 million anthrax vaccinations to more than 315,000 servicemembers, but supply problems jeopardize its schedule for vaccinating all 2.4 million servicemembers, and DOD lacks a contingency plan in the event these problems are not resolved in time; (2) test failures and problems in the testing itself have slowed or precluded release of 26 of the 40 vaccine lots since testing began in January 1998; (3) only 14 lots have been released to DOD since January 1998, and most of these have already been used; (4) moreover, the manufacturer has yet to receive Food and Drug Administration (FDA) permission to release lots produced after restarting operations in May 1999 following a 17-month shutdown for renovations; (5) DOD has fallen behind its original schedule by 5 months, and it risks further disruption if more vaccine does not become available by August 2000; (6) DOD has a new recording and tracking system for vaccinations that is better than the one used during the Gulf War and in Bosnia, but DOD is not meeting its requirement to record vaccination data consistently in paper records and in its central database; (7) GAO's comparison of records from DOD's central database and files at three military installations showed that 85 to 97 percent of paper and electronic records agreed on the number of anthrax vaccinations given to servicemembers, but agreement was lower at two of those sites for dates and lot numbers; (8) agreement in all categories was much lower at a fourth installation, with match rates of 8 to 22 percent, in part because individuals' duty stations had not been updated; (9) this data is vital for: (a) scheduling the FDA-licensed regimen of 6 vaccinations and boosters; and (b) tracking who receives vaccinations from a specific lot, should health concerns about a lot later emerge; (10) delays in updating data on individuals' duty stations have impeded DOD's ability to use its central database to manage vaccination schedules and assess unit readiness; (11) DOD has used data from the Vaccine Adverse Event Reporting system to monitor adverse reactions to anthrax vaccinations; (12) however, DOD has not systematically informed its personnel on how to provide needed data into the system; (13) as a result, DOD may not have data on adverse reactions that is important for monitoring vaccine safety; and (14) DOD has employed a high-visibility campaign to educate servicemembers about the program and has taken steps to address the controversy surrounding the program. https://www.govinfo.gov/content/pkg/GAOREPORTS-NSIAD-00-36/html/GAOREPORTS-NSIAD-00-36.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-NSIAD-00-36/pdf/GAOREPORTS-NSIAD-00-36.pdf GAO/NSIAD-00-36 https://www.govinfo.gov/app/details/GAOREPORTS-NSIAD-00-36 Letter Report GAO/NSIAD-00-36; Medical Readiness: DOD Faces Challenges in Implementing; Immunization services Safety standards Data integrity Reporting requirements Biological warfare Defense procurement Military personnel Product safety Medical information systems Health hazards DOD Anthrax Immunization Program DOD Enrollment Eligibility Reporting System CDC/FDA Vaccine Adverse Events Reporting System DOD Composite Health Care System Public Law 100-65