Medical Readiness:

DOD Faces Challenges in Implementing Its Anthrax Vaccine Immunization Program

NSIAD-00-36: Published: Oct 22, 1999. Publicly Released: Oct 22, 1999.

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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.

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 for Executive Action

  1. Status: Closed - Implemented

    Comments: The Anthrax Vaccination Immunization Program plans to pursue standardization and migration of service-specific data systems to a successor, joint service, long-term immunization tracking system. Based on the identification of functional requirements, the services are continuing to work toward a single, standardized tracking systm, CHCS II. This system was field tested and initially deployed in early 2001. Complete deployment is projected by early FY 2004.

    Recommendation: The Secretary of Defense should direct the Defense Manpower Data Center to review service requirements for recording and tracking medical data and incorporate plans to address these requirements in future upgrades of the Composite Health Care System.

    Agency Affected: Department of Defense

  2. Status: Closed - Implemented

    Comments: The Defense Manpower Data Center has studied the shortfalls in the timeliness of personnel duty station data in the Defense Enrollment Eligibility Reporting System. Also, the services are continuing to work to ensure timely and accurate data in the immunization tracking system and DEERS. The Army, in particular, has made significant progress through fielding of SIDPERS III, which has improved personnel action timeliness by 50% over SIDPERS II.

    Recommendation: The Secretary of Defense should direct the Defense Manpower Data Center to assess the timeliness of personnel duty station data in the Defense Enrollment Eligibility Reporting System to determine where time lags occur in obtaining data and take or recommend steps to resolve untimely submissions.

    Agency Affected: Department of Defense

  3. Status: Closed - Implemented

    Comments: DOD continues to assess their education efforts from multiple forums, including their web site, information line, user talk back lines, commanders, supervisors and servicemembers, and multiple speaking/briefing engagements. DOD noted that their initial education efforts were not effective in addressing servicemembers' information needs and they have modified their efforts in response to servicemembers' feedback.

    Recommendation: To address the challenges DOD faces in vaccinating its total force against anthrax, the Secretary of Defense should direct the Secretary of the Army, as Executive Agent for the anthrax vaccination program, to continue improvements in educational efforts by regularly surveying vaccine recipients and addressing their educational needs.

    Agency Affected: Department of Defense

  4. Status: Closed - Implemented

    Comments: DOD has established a committee to define gaps in knowledge and plan a research agenda regarding short and long term effects from the anthrax vaccine. Plans and funding for studies are in process, but some data collection has started. Some studies may be completed within several months, but other studies will take years to complete.

    Recommendation: To address the challenges DOD faces in vaccinating its total force against anthrax, the Secretary of Defense should direct the Secretary of the Army, as Executive Agent for the anthrax vaccination program, to design and conduct a study on possible long-term side effects of the anthrax vaccine and develop a communications plan to provide servicemembers information on the status of this effort.

    Agency Affected: Department of Defense

  5. Status: Closed - Implemented

    Comments: DOD has issued some clarifying guidance on reporting adverse reactions to vaccines.

    Recommendation: To address the challenges DOD faces in vaccinating its total force against anthrax, the Secretary of Defense should direct the Secretary of the Army, as Executive Agent for the anthrax vaccination program, to improve DOD guidance and training on how to report adverse events to the Vaccine Adverse Event Reporting System and refrain from inappropriately using data from the system to report an adverse reaction rate.

    Agency Affected: Department of Defense

  6. Status: Closed - Implemented

    Comments: DOD is collecting information on service members refusing to take the anthrax vaccine. The Undersecretary of Defense for Planning and Reporting issued a memorandum on January 16, 2001, directing the services to track, record, and report separations that result from refusing to participate in the AVIP program. Also, as required by Congress, the first DOD report was issued in April 2001. When the program begins to increase vaccinations, the services will continue to monitor refusals.

    Recommendation: To address the challenges DOD faces in vaccinating its total force against anthrax, the Secretary of Defense should direct the Secretary of the Army, as Executive Agent for the anthrax vaccination program, to routinely collect and report, among other program performance measures, data on the number of servicemembers refusing to take the vaccine.

    Agency Affected: Department of Defense

  7. Status: Closed - Implemented

    Comments: DOD has developed a strategy addressing the shortage of anthrax vaccine in view of dwindling supplies. DOD has also put out a request for proposals for other manufacturers to produce vaccine.

    Recommendation: To address the challenges DOD faces in vaccinating its total force against anthrax, the Secretary of Defense should direct the Secretary of the Army, as Executive Agent for the anthrax vaccination program, to prepare a formal, written plan that addresses strategies to deal with: (1) contingencies for vaccinating servicemembers if the supply of anthrax vaccine is not augmented with new production; and (2) the risks associated with reliance on a single vaccine manufacturer.

    Agency Affected: Department of Defense

  8. Status: Closed - Implemented

    Comments: Each service now assesses the impact of AVIP on recruiting and retention. Currently, the impact have been very low because of the slow down of the program. The congressionally mandated, DOD-wide exit survey, which allowed service members the opportunity to identify reasons for resigning from the military, permitted the service members to provide specific reference to AVIP in the "other" category.

    Recommendation: The Secretary of Defense should direct the Defense Manpower Data Center to include the response "to avoid the mandatory anthrax vaccine" or words to that effect, among the answers to questions on the reasons for resigning from the military in the DOD-wide exit survey to be administered in 2000.

    Agency Affected: Department of Defense

 

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