Department of Defense Anthrax Vaccination

Department of Defense Anthrax Vaccination

Order Code RL30748
CRS Report for Congress
Received through the CRS Web
Department of Defense Anthrax Vaccination
November 7, 2000
(name redacted)
Specialist in National Defense
Foreign Affairs, National Defense, and Trade Division
Congressional Research Service ˜ The Library of Congress

Department of Defense Anthrax Vaccination
Summary
The Department of Defense (DOD) intends to immunize 1.4 million active duty
and 900,000 Selected Reserve personnel against anthrax. The vaccine, approved by
the Food and Drug Administration (FDA), has been in use since 1970. About
455,000 personnel have started the vaccination series, and, according to DOD, at
least 442 have refused the vaccine. DOD deems the immunization to be mandatory,
and active duty personnel who have refused have been subject to administrative
discharge or court martial for failure to obey a lawful order. Some Reserve and
National Guard personnel have resigned rather than take the vaccine. Legislation was
introduced in the 106th Congress to delay the program pending further research (H.R.
2543, H.R. 2548), however these bill have not been reported from committee.
Congress also addressed the anthrax vaccination program in the DOD FY2001
Authorization Act (P.L. 106-398, Sec. 217, 218, 751), establishing a broad range of
reporting requirements and monitoring efforts.
Questions have been raised about the vaccine’s efficacy against all forms of
anthrax, possible long-term adverse effects, the reliability of the adverse reaction
reporting system, the reliability of the manufacturer, and DOD’s contractual
arrangements with the manufacturer. The House Government Reform Committee and
its Subcommittee on National Security, Veteran’s Affairs, and International Relations;
the House Armed Service’s Military Personnel Subcommittee; and the Senate Armed
Services Committee have held hearings, with representatives from DOD, the Food
and Drug Administration (FDA), and the General Accounting Office (GAO).
Members of the military who believe their anthrax vaccination caused a variety of
medical ailments, and members who refused the vaccination and received disciplinary
action or chose to leave the service also testified. The House Committee on
Government Reform has also issued a report prepared by the majority staff
summarizing its conclusions regarding the program.1. The Department of Defense and
the U.S. Food and Drug Administration continue to maintain that the vaccine is safe
and the most effective medical protection currently available against anthrax, and that
adverse reactions to the vaccine remain at a lower rate than other widely-administered
vaccines.
This report will not be updated, unless there are significant new developments.
1 The Department of Defense Anthrax Vaccine Immunization program – Unproven Force
Protection, House Committee on Government Reform. February 17, 2000.
[http://www.house.gov/reform/]

Contents
Concerns about the Anthrax Vaccine Program . . . . . . . . . . . . . . . . . . . . . . 3
Vaccine Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Vaccine Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Vaccine Production and Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Congressional Action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Department of Defense Anthrax Vaccination
On December 15, 1997, the Department of Defense announced plans to
vaccinate all active duty personnel against anthrax, a highly lethal disease caused by
the bacterium Bacillus Anthracis. At least 10 countries are suspected of having
developed or trying to develop anthrax as a biological weapon. In testimony before
the Senate Armed Services Committee, the Joint Chiefs of Staff Director of
Intelligence identified seven of these countries: Russia, China, Iran, Iraq, Libya, North
Korea, and Syria.2
The vaccinations began in March 1998 with an advance program for the 48,000
troops assigned to the Persian Gulf region. On May 18, 1998, Secretary Cohen
approved the total force vaccination program, and the full program began in
September with troops in Korea being a priority. It was expected to take about seven
years to vaccinate all 1.4 million active duty and 900,000 Selected Reserve personnel,
however difficulties in obtaining sufficient supplies of vaccine will probably extend
this estimate.3 Prior to this program over 3,000 civilian and military personnel
associated with DOD’s biological warfare defense activities were routinely
vaccinated. An abbreviated immunization series of injections was also given to about
150,000 troops deployed to Southwest Asia during the Persian Gulf conflict in 1990-
91.4
The U.S. Food and Drug Administration first approved the vaccine for use in
1970. Anthrax primarily infects grazing animals, such as sheep and cattle, and the
vaccine is given to veterinarian and livestock workers who are at risk from exposure
to the disease. The full immunization process currently involves six injections
delivered over 18 months, followed by annual booster shots. If the vaccination series
is interrupted, the FDA does not require re-starting the series from the beginning, but
rather approves continuing with the remaining shots. This is in keeping with the
recommendation of the Centers for Disease Control and Prevention’s Advisory
Committee for Immunization Practices. The vaccine does not contain live Anthracis
bacteria; it is a “killed bacteria” vaccine.
As of July 2000, about 447,000 personnel had started the vaccination series.
According to DOD data, 442 personnel have refused the vaccination, and have
received punishments ranging from a general discharge under honorable conditions
to courts-martial resulting in bad conduct discharges for failing to obey a lawful order.
2 Proliferation: Threat and Response, Department of Defense, November 1997.
3 Department of Defense Overview: DOD Biological Warfare Defense Immunization
Program. [http://www.defenselink.mil/other_info/overview.html]
4 The vaccination series was abbreviated owing to a lack of available vaccine and lack of time
prior to deployment.

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This is in keeping with DOD policy regarding all FDA-licensed immunizations given
to military personnel. The disparity in punishment has received criticism, but DOD
maintains that the disciplinary actions remain at the discretion of the local commander,
and that no DOD-wide policy will be imposed on the services. Critics of the program
maintain that significant numbers of personnel, particularly among the reserves, are
choosing to leave the service rather than take the vaccine, and DOD has
acknowledged that its records would not reflect those individuals. This has raised
concerns over the program’s effect on personnel retention and readiness, although
DOD maintains that the effect has been minimal. In response to this, the FY2001
DOD Authorization Act (P.L. 106-398) requires a GAO report by April 2002 on the
impact of this program on personnel recruitment and retention.
Secretary of Defense Cohen directed that the DOD vaccination program be
preceded by:
! Testing, in accordance with FDA standards, to assure the safety,
potency, and purity of the vaccine.
! Implementation of a personnel tracking system for those who are
vaccinated.
! Operational plans for vaccine administration and for informing
military personnel about the program.
! Review of the health and medical issues by an independent expert.
Mitretek Systems Inc. is conducting supplemental testing of vaccine lots
previously approved for release by the FDA to assure safety and potency. As
discussed below, not all these lots have been re-approved for release, thereby creating
a shortage of vaccine that will extend into 2001 (See Vaccine Production and
Testing). Personnel data on those vaccinated is currently being entered in the
Defense Enrollment Eligibility Reporting System (DEERS), and eventually will be
entered in a newly developed joint-service Preventative Health Care System for long-
term tracking of immunization status.
The independent review of the immunization program was conducted by Dr.
Gerard M. Burrows, David Page Smith Professor of Medicine at Yale Medical School
and Special Advisor to the President for Health Affairs. He completed his independent
review of the anthrax vaccination program on February 19, 1998, concluding that “the
anthrax vaccine appears to be safe and offers the best available protection against
anthrax as a biological warfare agent” and that, aside from not vaccinating pregnant
personnel and those with immune systems deficiency, “there would not seem to be the
need for special considerations.”5 There has been criticism, however, that Dr.
Burrows is not a specialist in immunology or biological warfare, and consequently the
value of his review is limited.
5 Report on the DOD Anthrax Vaccination Program, Department of Defense.
[http://www.defenselink.mil/other_info/burrows.html] ; Testimony of Rear Admiral Lowell
Jacoby, Director of Intelligence, Joint Staff before the Senate Committee on Armed Forces,
April 13, 2000. [http://www.senate.gov/~armed_services/hearings/2000/c000413.htm]

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Concerns about the Anthrax Vaccine Program
The anthrax vaccination program has become a focus of controversy and
congressional concern for a variety of reasons. Questions have been raised about the
vaccine’s efficacy against all forms of anthrax, possible long-term adverse effects, the
reliability of the adverse reaction reporting system, the reliability of the manufacturer,
and DOD’s contractual arrangements with the manufacturer. The House Government
Reform Subcommittee on National Security, Veteran’s Affairs, and International
Relations, the House Armed Services Subcommittee on Military Personnel, and the
Senate Armed Services Committee have held hearings, providing testimony from a
broad range of witnesses, including representatives from DOD, the Food and Drug
Administration (FDA), and the General Accounting Office (GAO). Members of the
military who believe their anthrax vaccination has caused a variety of medical
ailments, and members who have refused the vaccination and have received
disciplinary action or chosen to leave the service have also testified. The House
Government Reform Committee has also published a report detailing its National
Security Subcommittee’s critique of the vaccination program.6
Some members of the U.S. Air National Guard and Air Force Reserve have been
among the vocal of opponents to the vaccination program, and significant numbers
have left the service rather than participate. The General Accounting Office provided
preliminary results of a study to the House Committee on Government Reform,
indicating that the program was indeed a serious consideration among those pilots
leaving the Guard and Reserve.7
The Department of Defense and the Food and Drug Administration in their
testimony continue to maintain that the vaccine is safe and the most effective medical
protection currently available against anthrax. 8 Charles Cragin, Acting Assistant
Secretary of Defense for Reserve Affairs has noted that in addition to the FDA, the
United Nations World Health Organization, the American Public Health Association,
the American College of Physicians, and the National Institutes of Health have
endorsed the vaccine.9
Vaccine Effectiveness. The controversy over the vaccine’s effectiveness centers
on its ability to protect against inhalation anthrax and its ability to protect against
genetically-engineered strains that could be developed as a biological weapon.
Anthrax is naturally most often contracted through cuts or abrasions in the skin which
come in contact with contaminated animal products, or through ingestion of
contaminated meat. As a biological weapon, however, anthrax is far more likely to
be delivered as a spore aerosol that would be inhaled. Critics of the vaccine program
6 Department of Defense Anthrax Vaccine Immunization Program: Unproven Force
Protection, H.Rept. 106-556.
[http://www.house.gov/reform/ns/reports/subcommittee_reports.htm]
7 Testimony before House Committee on Government Reform, October 11, 2000.
8 Testimony from these hearings is available on the Subcommittee’s website.
[http://www.house.gov/reform/ns/hearings/subcommittee_hearing_testimony2.htm]
9 Department of Defense, American Forces Press Service Release, August 18, 1999.

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point out that there is very little data based upon human studies upon which to judge
the vaccine’s effectiveness against inhalation anthrax.10 Given that anthrax is a fatal
disease, “challenge” studies (i.e. exposing vaccinated subjects to anthrax spores to
determine immunity) cannot be performed. Consequently, the only public study
involving humans was based upon observation of a limited group of wool workers,
and though none of the vaccinated workers contracted anthrax and unvaccinated ones
did, the small number of people involved limits the value of the study. DOD’s
assessment of the vaccine’s effectiveness against inhalation anthrax is based upon
studies conducted with rhesus monkeys. Dr. Arthur Friedlander, Chief Bacteriologist
at the Army Medical Research Institute of Infectious Diseases, has testified that the
vaccine protected 95% of the test subject Rhesus monkeys exposed to anthrax doses
“hundreds of times greater than the amount that kills an unprotected population.”11
The General Accounting Office has noted, however, that there is inadequate data on
correlating the effectiveness of this vaccine in monkeys to its effectiveness in
humans.12 DOD and the FDA are currently working to develop the data required for
this correlation.
Concerns have also been repeatedly raised that the vaccine may not protect
against all 31 known strains of anthrax, and that it would be possible to develop a
genetically engineered strain against which the vaccine would not be effective. On
September 30, 1999, Lt. Gen. Robert R. Blanck, Surgeon-General of the Army
testified before the House Armed Services Military Personnel Subcommittee that “we
have solid evidence that this [vaccine] will protect against all natural strains of
anthrax.” At the same hearing, Deputy Secretary of Defense Hamre testified “we
have no evidence that anyone has genetically engineered an anthrax strain to the point
that it can be weaponized and is a threat”, but acknowledged that were this to occur
there is the possibility that the current vaccine would not be effective. With this in
mind, critics of the program insist that the vaccine’s possible limitations be openly
acknowledged. The vaccination program’s supporters maintain that the question of
the vaccine’s effectiveness against potential new anthrax strains should not
overshadow its effectiveness against the current anthrax threat agents.
The Health and Human Services Department, in cooperation with DOD, is
currently working to develop an improved anthrax vaccine, and one which could
reduce the number of shots required to achieve immunization. Although the FDA-
approved protocol currently requires 6 shots, it has been suggested that data
supporting this requirement is not conclusive, and that a protocol requiring fewer
shots could be approved. The FDA is currently reviewing development of a new
protocol.13
10 House Government Reform Subcommittee on National Security, Veteran’s Affairs, and
International Relations, Hearing , July 21, 1999.
[http://www.house.gov/reform/ns/hearings/testimony/july_21.htm]
11 U.S. General Accounting Office, Medical Readiness: Safety and Efficacy of the Anthrax
Vaccine. GAO/T-NSIAD-99-148. p. 4..
12 Ibid.
13 Testimony before the House Government Reform Subcommittee on National Security,
(continued...)

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Vaccine Safety. The manufacturer, the FDA, and DOD maintain that, in the
twenty-nine years of administering the vaccine, no permanent or chronic adverse
reaction has been reported.14 Although the anthrax vaccine has been in use since the
1970's, there has been no study conducted that actively followed the long-term
medical conditions of those receiving the vaccine. The FDA’s assertion that there
have been no long-term or chronic adverse health effects from the vaccine is based
upon data received through the Vaccine Adverse Events Reporting System (VAERS).
This system relies upon physicians or patients taking the initiative to report effects
believed to be caused by any vaccination. Because it is not a system of active medical
surveillance of those receiving vaccinations, it has been criticized as under-reporting
adverse events, particularly those could occur long after the vaccination and therefore
not obviously connected. It should be noted that there is a distinction between an
“adverse event”, which is any medical event or condition that occurs after the
vaccination and may or may not be associated with the vaccination, and an “adverse
reaction”, which is a medical event or condition that can be directly attributed to the
vaccination.
From 1990 through September 2000, 1,561 adverse events associated with the
anthrax vaccine have been reported to the FDA through the VAERS – a lower than
average number of reports for vaccines, according to the FDA, given that during this
period 2 million doses of the vaccine were administered. Of the 1,404 adverse events,
76 were judged serious (i.e. life-threatening, requiring hospitalization, or resulting in
permanent disability), but diverse in nature with no clear patterns emerging. Of the
76 reports, 55 were judged to be reactions to the vaccination, and all personnel have
recovered and returned to duty. The FDA has testified that, aside from injection site
reactions (e.g. swelling, localized pain), “none of these events...can be attributed to
the vaccine with a high level of confidence, nor can contribution of the vaccine be
entirely ruled out”.15 The FDA has concluded that “the reports on the anthrax vaccine
received thus far do not raise any specific concerns about the safety of the vaccine.”16
Army Surgeon-General Blanck has also noted that over the last 20 years more than
3,000 personnel working in the Army’s biological warfare defense program have
13 (...continued)
Veteran’s Affairs, and International Affairs, July 21, 1999.
14 “Amid Concerns over Anthrax Immunization Plan, DOD Remains Confident”, Inside the
Pentagon, January 28, 1998, p. 1.
15 Testimony of Kathryn Zoon, Director of the FDA Center for Biologics Evaluation and
Research before the Senate Committee on Armed Services on July 12, 2000, and testimony
of Mark Elengold, Deputy Director of the FDA Center for Biologics Evaluation and Research
before the House Government Reform Committee, October 3, 2000.
[http://www.senate.gov/~armed_services/hearings/2000/c000712.htm] Testimony of Army
Surgeon-General Blanck before the House Govermental Reform Subcommittee on National
Security, Veterans Affairs, and International Affairs, March 24, 1999.
[http://www.house.gov/reform/ns/hearings/testimony/witnesslistfor3-24.htm]
16 Ibid

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received the vaccinations and that they routinely undergo regular physical
examinations which have detected no long term medical effects.17
A number of Service members testifying before the House Government Reform
Subcommittee on National Security, Veteran’s Affairs, and International Affairs
maintain that military physicians have been reluctant to report their medical
complaints through VAERS because their symptoms do not conform to anticipated
vaccine reactions. Consequently, they maintain that there is a “filtering” effect
inherent in the VAERS which would also contribute to under-reporting. They
strongly believe that their on-going medical conditions are a direct result of their
vaccinations, and believe their cases should not be excluded from consideration of the
vaccine’s safety.18
Some service personnel and members of the public have associated the anthrax
vaccine with the controversy over illnesses experienced by veterans of the Persian
Gulf War. The independent Presidential Advisory Committee on Gulf War Veteran’s
Illnesses determined that no evidence could be found connecting the vaccine with
subsequent illnesses.19
On September 28, 2000 another issue arose when a Michigan county medical
examiner told a local newspaper that a reaction to the anthrax vaccine had contributed
to a 61-year old Bioport employee’s death. The pathologist who actually performed
the autopsy disagreed with that assessment, asserting that the employee died of a
ventricular arrhythmia, a cardiac artery inflammation, which could not be definitely
linked to the vaccine. Both the FDA and the Department of Defense have obtained
copies of the autopsy report, and will conduct independent investigations.20
Vaccine Production and Testing. There have been some concerns raised about
the vaccine production facility and the retesting of stockpiled vaccine. The vaccine
was originally manufactured by the Michigan Biologic Products Institute (MBPI), the
only licensed manufacturer of human anthrax vaccine in the United States. Food and
Drug Administration inspectors repeatedly cited this facility for quality control and
record-keeping deficiencies during 1993-97. With MBPI having failed to take
corrective action, the FDA issued a warning of license revocation in March 1997.
The revocation, however, did not take place, and the facility passed subsequent FDA
inspections. In the Spring 1998, the state of Michigan sold MBPI to a private
corporation, Bioport, Inc. The facility was then shut down for renovations, partially
funded by DOD, to increase its production capacity. Renovated from the ground up,
the new Bioport facility underwent an initial FDA inspection in November 1999. The
FDA found shortcomings in a number of areas, including: deviation reporting, filling
17 Testimony before the House Armed Services Subcommittee on Military Personnel,
September 30, 1999.
18 Testimony before the House Government Reform Subcommittee on National Security,
Veteran’s Affairs, and International Affairs, March 24, 1999.
19 Presidential Advisory Committee on Gulf War Veteran’s Illnesses Final Report., p. 112
20 “Pathologist Cannot Confirm Anthrax Vaccine Link to Death of Bioport Corp. Employee”,
PRNewswire, September 29, 2000.

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operations, stability testing, and environmental operations. 21 Bioport and
independent consultants are currently working with the FDA to bring the facility into
compliance. FDA officials have estimated that this will take until early or mid-2001.
In the interim, Bioport is manufacturing only test lots of vaccine.
This lack of production created a vaccine shortage and forced DOD to alter its
policy of vaccinating all personnel deploying to Korea and Southwest Asia. Now only
those who will be deployed to those regions for more than 30 days will be vaccinated.
On this reduced schedule, DOD estimates there is sufficient stockpiled vaccine to last
until March 2001. DOD had expected that stockpiled vaccine that was being re-
tested by independent consultants and the FDA to ensure its safety and potency would
be sufficient to carry through Bioport’s shutdown for renovations. However, the
retesting is taking longer than expected, and some vaccine lots have been rejected for
lack of potency.
Concerns about Bioport’s financial stability also arose when the company, in
order to remain solvent, required a renegotiation of the vaccine procurement contract
which raises the per dose price from $4.36 to $10.64, raising the contract price from
$25.7 million to $49.8 million, including an $18 million advance payment. The
renegotiation was requested by Bioport, Inc., which maintained that the facility’s
former financial sponsorship by the state of Michigan led to an inaccurate initial
estimate of production costs, and without additional DOD support the facility would
have to close. The Army Contract Adjustment Board approved the renegotiation on
July 27, 1999.
These difficulties with the Bioport facility have led DOD to explore ways to
establish a second production source. The U.S. pharmaceutical industry is being
canvassed, though the industry has shown little interest, owing to the relative lack of
profitability in an anthrax vaccine. Consequently, DOD will request funding in
FY2002 for a study to determine the advisability of building a government-owned,
contractor-operated (GO-CO) facility.22 Neither option will, however, provide a
second production facility in the short term. Estimates range from 4 to 7 years to
establish a fully licensed, functioning second facility, depending on whether an existing
plant is converted or a new one built.
Congressional Action. Congress addressed the anthrax vaccination program
in the DOD FY2001 Authorization Act (P.L. 106-398, Sec. 217, 218, 751) requiring
DOD to provide:
! Notification of FDA certification of the vaccine production facility.
! A report on the contingencies associated with relying on the current
vaccine manufacturer.
! A report, no later than February 1, 2001, on DOD acquisition
programs for biological warfare defense vaccines.
! An annual detailed report on the program costs.
21 Zoon Testimony, July 17, 2000.
22 “Pentagon Will Consider Building a GO-CO Vaccine Production Facility”, Inside the
Pentagon, November 2, 2000, p.7.

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! Tracking of separations from the armed services attributable to the
mandatory anthrax vaccination program
! A General Accounting Office report on the impact of the anthrax
vaccination program on personnel recruitment and retention
! Uniform procedures for medical exemptions from the vaccination
program.
! An expanded medical monitoring system for those vaccinated.
! A detailed vaccine modernization plan
In the 106th Congress, two additional bills regarding the anthrax vaccination
program were introduced: H.R. 2543 and H.R. 2548. The former, introduced by Rep.
Walter Jones, directs the Secretary of Defense to make the anthrax vaccination
immunization program voluntary for all members of the armed forces until the Food
and Drug Administration has approved a new anthrax vaccine for humans or a new,
reduced course of shots for such vaccine. It has been referred to the House Armed
Services Subcommittee on Personnel. H.R. 2548, introduced by Rep. Gilman, would
direct DOD to suspend the immunization program pending an independent study on
the safety and effectiveness of the vaccine, and an evaluation of that study by the
National Institutes of Health. It would also require expedited review of the
disciplinary actions taken against those who have refused the vaccination. H.R. 2548
has been referred to the House Committees on Armed Services and Commerce.
The Department of Defense has established a WWW site to provide information
o n t h e a n t h r a x v a c c i n a t i o n p r o g r a m
[http://www.defenselink.mil/other_info/burrows.html]. A moderated Internet
discussion by healthcare professionals of anthrax immunization in general is also
available [http://www.healthnet.org/programs/promed.hma.html].

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