Medical Readiness: DOD Continues to Face Challenges in Implementing Its Anthrax Vaccine Immunization Program Page: 2 of 10
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Mr. Chairman and Members of the Committee:
We are pleased to be here today to discuss our past work on the
Department of Defense's (DOD) anthrax vaccine immunization program.
As you know, DOD regards the biological agent anthrax, an infectious
disease that is 99-percent lethal if inhaled by unprotected humans, as the
single greatest biological weapon threat to U.S. military forces. DOD
considers vaccination one of the measures critical to protecting U.S.
forces against such weapons. In December 1997, the Secretary of Defense
announced a plan to immunize all active and reserve military personnel
with a licensed anthrax vaccine. In August 1998, DOD began immunizing
all 2.4 million U.S. military personnel-including all active and reserve
personnel-against anthrax.
Today we would like to provide a brief update on three key findings of our
October 1999 report. The findings relate to vaccine supply, medical
records, and efforts to educate servicemembers about the program.1 We
have also reviewed other aspects of the anthrax vaccine immunization
program, including the safety and efficacy of the vaccine and the contracts
with the manufacturer. Our related reports are listed in an attachment to
this statement.Summary
In October 1999, we reported on challenges to implementing DOD's
anthrax immunization program. First, we noted that supply problems
caused by the manufacturer's inability to obtain Food and Drug
Administration (FDA) approval to distribute vaccine manufactured at its
renovated facility and problems testing previously stockpiled vaccine
jeopardized DOD's schedule for vaccinating all 2.4 million
servicemembers. Today, this fundamental requirement of the program-
maintaining an adequate supply of vaccine-has not yet been met. The
manufacturer has not yet obtained FDA approval to distribute vaccine
produced at its renovated facility, and this approval is not expected until
late 2000. Program officials expect the current supply to last until July
2000. Although program officials expect FDA to approve the release of
previously stockpiled vaccine before the available supply is depleted, this
expectation may be optimistic given past testing problems. DOD is
vaccinating only personnel who are being deployed to high-threat areas
and has delayed vaccinations of personnel in units scheduled for early
deployment. If the manufacturer does not obtain FDA approvals as
1 Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax Vaccine Immunization
Program (GAO/NSIAD-O0-36, Oct. 22, 1999).GAO/T-NSIAD-00-157
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United States. General Accounting Office. Medical Readiness: DOD Continues to Face Challenges in Implementing Its Anthrax Vaccine Immunization Program, text, April 13, 2000; Washington D.C.. (https://digital.library.unt.edu/ark:/67531/metadc289489/m1/2/: accessed April 19, 2024), University of North Texas Libraries, UNT Digital Library, https://digital.library.unt.edu; crediting UNT Libraries Government Documents Department.