Medical ReadinessDOD Faces Challenges in Implementing Its Anthrax Vaccine Immunization Program Gao ID: NSIAD-00-36 October 22, 1999
As of July 1999, the Defense Department (DOD) has vaccinated more than 315,000 servicemembers against anthrax, but supply problems continue to jeopardize its schedule for vaccinating all 2.4 servicemembers. Moreover, DOD lacks a contingency plan in the event that these problems are not resolved in time. DOD has a new recording and tracking system for vaccinations that is better that the one used during the Gulf War and in Bosnia, but DOD has not been consistently recording vaccination data in paper records and in its central database. DOD has used information from the Vaccine Adverse Event Reporting System to monitor adverse reactions to anthrax vaccinations. The system relies on medical personnel and troops to provide needed data. However, DOD has not systematically told these personnel how to enter needed data into the system. As a result, DOD could lack data on adverse reactions that is important for monitoring vaccine safety. DOD has used a high-visibility campaign to educate servicemembers about the program and has tried to address the controversy surrounding the program. In addition, it recently expanded its communications efforts by updating the program's Internet site, opening a toll-free anthrax hotline, and forming a speakers' bureau of anthrax experts. However, a GAO survey of four military installations found that servicemembers wanted more information on some issues. More than two-thirds of survey respondents said that the information they received on the reasons for the program, shot requirements and schedules, and consequences of refusals was at least moderately helpful. However, more than half of the servicemembers said that they received either no information on possible long-term side effects and procedures for reporting side effects or found that information less than moderately helpful.
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.Recommendations
Our recommendations from this work are listed below with a Contact for more information. Status will change from "In process" to "Open," "Closed - implemented," or "Closed - not implemented" based on our follow up work.Director: Team: Phone: