State Department:

Serious Problems in the Anthrax Vaccine Immunization Program

GAO-01-21: Published: Dec 13, 2000. Publicly Released: Jan 16, 2001.

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In 1998, the State Department stockpiled anthrax vaccine and antibiotics at several diplomatic posts near Iraq. In the event of an anthrax attack by Iraq, this stockpile was to be used for post-exposure immunization and treatment. In 1999, the State announced that it was starting a voluntary Anthrax Immunization Program for U.S. government employees, their dependents, and other personnel overseas. According to the Food and Drug Administration (FDA), full pre-exposure protection from anthrax requires six vaccinations given over an 18-month period, followed by an annual booster. Because the supplies of vaccines approved by FDA were insufficient, State decided to suspend plans to expand the program beyond the pilot site until more vaccine was available. GAO found that both the State Department's prepositioning of anthrax vaccine at diplomatic missions and the voluntary anthrax immunization program have been poorly implemented. Specifically, the vaccine was not properly stored or refrigerated, requirements for the voluntary program were not accurately estimated, and surveillance procedures used in the pilot program to monitor reactions to the vaccine were inadequate.

Recommendations for Executive Action

  1. Status: Closed - Implemented

    Comments: Based on its experience at the pilot site, the State Department plans to order for shipment only what is needed, based upon specific requests from the health units. These requests will be based on a survey conducted at each post. State plans to send only enough vaccine for the first three doses per person, then refine future orders based on actual usage. According to State's December 29, 2003 update of its action on GAO's recommendations, while they had started to do the surveys, they had to put them on hold because of the conflict in Iraq. When war is not imminent or in non-urgent settings, State intends to continue the surveys and review the results of post surveyed needs or estimates of vaccinations given before allotments of vaccine are shipped to individual posts.

    Recommendation: To better define and evaluate the need for the voluntary anthrax vaccine immunization program and improve the implementation of any future immunization efforts, the Secretary of State should improve the implementation of any future immunization efforts by developing estimates of vaccine requirements based on actual experience at the pilot location and a site survey of U.S. employees, their dependents, and foreign service nationals at the next locations to receive the vaccine.

    Agency Affected: Department of State

  2. Status: Closed - Implemented

    Comments: The State Department has initiated a purchase request for an automated environmental monitoring system, as recommended by DOD, to be used at the pilot post. The unit will monitor temperature and power, and will activate an alarm and telephonically notify key personnel of any system failure. State plans to purchase a monitor system for each post prior to the phased implementation of the immunization program. According to State's December 29, 2003 update of its actions on GAO's recommendations, they have purchased temperature monitoring equipment that is being field tested at multiple locations and has placed orders for temperature monitoring equipment which State plans to have available for the next phase of vaccine deployment.

    Recommendation: To better define and evaluate the need for the voluntary anthrax immunization program and improve the implementation of any future immunization efforts, the Secretary of State should improve the implementation of any future immunization efforts by requiring that appropriate vaccine storage and redistribution mechanisms are in place before anthrax vaccine is shipped overseas.

    Agency Affected: Department of State

  3. Status: Closed - Not Implemented

    Comments: The State Department states that it has requested that the intelligence community provide a complete assessment, but has not yet received a response. However, until they receive a response, they will not discontinue the program, but will continue to offer the vaccine to State employees at the pilot site as long as the supply is available.

    Recommendation: To better define and evaluate the need for the voluntary anthrax immunization program and improve the implementation of any future immunization efforts, the Secretary of State should obtain from the intelligence community a more complete assessment of the threat and probability of a chemical and biological attack on U.S. diplomatic missions. This assessment should address (1) the relative risks of a chemical or biological attack for each mission, (2) types of chemical and biological agents likely to be used, and (3) the ability of states or terrorist groups to disperse these agents and cause casualties. In addition, the Secretary of State should reassess the need to continue the pilot program until a complete threat assessment is conducted.

    Agency Affected: Department of State

  4. Status: Closed - Not Implemented

    Comments: The State Department believes that the Vaccine Adverse Event Reporting System (VAERS) is adequate to track adverse reactions from the anthrax vaccine and cites the "Statement of Information and Affirmation" it provides to State recipients of the vaccine, which includes instructions for reporting adverse effects from the vaccine to the VAERS program. However, the State Department stated that it would implement an active surveillance system it developed with the Center for Disease Control, which will study and monitor the adverse health events from anthrax vaccination on State employees. While State did not implement the study at the pilot program, it stated that the study will take place at other sites when the vaccine becomes available. However, according to State's December 29, 2003 update on actions it has taken on GAO's recommendations, it no longer believes that a study is necessary because of the Institute of Medicine's April 2002 determination that anthrax vaccine is reasonably safe with reaction rates comparable to those observed with other vaccines. State will therefore administer anthrax vaccine like any other vaccine and continue to use the VAERS.

    Recommendation: To better define and evaluate the need for the voluntary anthrax immunization program and improve the implementation of any future immunization efforts, the Secretary of State should improve the implementation of any future immunization efforts by taking steps to determine whether active surveillance procedures would be more appropriate to track adverse reactions of future recipients in the program.

    Agency Affected: Department of State

  5. Status: Closed - Not Implemented

    Comments: State believes that it has a rigorous program in place to help keep patients on schedule for their anthrax immunizations through telephone reminders by health unit staff and through its Medical Immunization Tracking System database. State also believes that it has proven its ability to administer vaccine doses to personnel who change locations through its administration of anthrax vaccine to DOD personnel stationed at posts overseas. However, State has not established procedures to ensure that State employees who volunteered for immunizations could complete the 6-shot regimen before transferring to other posts. State will seek additional scientific evidence by monitoring the progress of the committees of the Institute of Medicine to determine the safety and efficacy of the anthrax vaccine. It will also review CDC and FDA reports to monitor progress in the field of research.

    Recommendation: To better define and evaluate the need for the voluntary anthrax immunization program and improve the implementation of any future immunization efforts, the Secretary of State should improve the implementation of any future immunization efforts by developing procedures that provide for each participating employee assigned to high-risk posts to complete the full six-shot regimen of anthrax vaccine on schedule and also seek additional scientific evidence in consultation with the Food and Drug Administration and the Department of Defense to determine the impact of deviations from the approved dosage schedule.

    Agency Affected: Department of State

 

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