Anthrax Vaccine: Preliminary Results of GAO's Survey of Guard/Reserve
Pilots and Aircrew Members (Testimony, 10/11/2000, GAO/GAO-01-92T).

This testimony discusses the Department of Defense's (DOD) Anthrax
Vaccine Program. Many questions have been raised about the program since
DOD began vaccinating its 2.4 million active duty and reserve members in
1998. A major concern has been the program's effect on the National
Guard and Air Force Reserve's retention of trained and experienced
personnel. A questionnaire sent to 1,253 randomly selected Guard and
Reserve pilots and others revealed that the anthrax immunization was a
key reason these individuals left or otherwise changed their military
status. Since September 1998, an estimated 25 percent of the pilots and
aircrew members of the Guard and Reserve in this population transferred
to another unit, left the military, or moved to inactive status.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  GAO-01-92T
     TITLE:  Anthrax Vaccine: Preliminary Results of GAO's Survey of
	     Guard/Reserve Pilots and Aircrew Members
      DATE:  10/11/2000
   SUBJECT:  Immunization services
	     Surveys
	     Product safety
	     Immunization programs
	     Health hazards
	     Armed forces reserves
	     Air Force reservists
	     Aircraft pilots
IDENTIFIER:  DOD Anthrax Immunization Program

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GAO-01-92T

   * For Release on Delivery
     Expected at 10:00 a.m.

Wednesday,

October 11, 2000

GAO-01-92T

anthrax vaccine

Preliminary Results of GAO's Survey of Guard/Reserve Pilots and Aircrew
Members

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Statement of Kwai-Cheung Chan, Director

Applied Research and Methods

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Testimony

Before the Committee on Government Reform, House of Representatives

United States General Accounting Office

GAO

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Mr. Chairman and Members of the Subcommittee:

We are pleased to be here today to discuss the preliminary results of the
ongoing work we are doing at your request on the Department of Defense's
(DOD) Anthrax Vaccine Immunization Program. As you know, numerous concerns
have been raised about the program since DOD began vaccinating its 2.4
million active duty and reserve members in 1998. Of particular concern was
the program's potential impact on the Air National Guard and Air Force
Reserve's retention of trained and experienced personnel.

In response to your request, we are examining the impact of the vaccination
program on retention, the basic views of Guard and Reserve pilots and other
aircrew members regarding the program, and the extent of adverse reactions
experienced by anthrax vaccine recipients. These components provide
essential support to critical defense operations on a worldwide basis. They
provide strategic and tactical airlift, aerial refueling, aeromedical
evacuation, and augment DOD's overall fighter force.

To conduct our work, we developed, pre-tested, and validated a questionnaire
that was sent to 1,253 randomly selected Guard and Reserve pilots and other
aircrew members. These included pilots, flight engineers, loadmasters,
navigators, crew chiefs, and others. Collectively, they represent about
13,000 servicemembers of the total fiscal year 1999 end strength of
approximately 176,000, which includes about 29,000 officers and 147,000
enlisted personnel. We shared the draft questionnaire with DOD program
officials and their medical experts and incorporated appropriate comments
and suggestions. We administered the survey on an anonymous basis between
May and September 2000. The overall response rate was 66 percent. Our
methodology is described in detail in appendix I. The information we are
presenting today has been weighted to represent the population of Guard and
Reserve pilots and other aircrew members who are currently active and
assigned to a unit.

Summary

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While many factors can influence an individual's decision to leave the
military, surveyed Guard and Reserve pilots and aircrew members cited the
anthrax immunization as a key reason for leaving or otherwise changing their
military status. Since September 1998, an estimated

25 percent of the pilots and aircrew members of the Guard and Reserve in
this population transferred to another unit (primarily in a non-flying
position), left the military, or moved to inactive status. While several
reasons influenced their decision, when asked to rank the one most important
factor, the anthrax immunization was the highest, followed by other
employment opportunities, and family reasons. Further, about one in five (18
percent) left before qualifying for military retirement benefits.
Additionally, 18 percent of those still participating in or assigned to a
unit reported their intentions to leave within the next 6 months. These
individuals also ranked the anthrax immunization as the most important
factor for their decision to leave, followed by unit workload and family
reasons. Each of these groupsthose who have left and those who plan to do
so-had accumulated an average of more than 3,000 flight hours, which
symbolizes a seasoned and experienced workforce.

On our survey, most Guard and Reserve pilots and aircrew members expressed a
positive view toward general immunizations. Almost three out of four believe
that immunizations are effective (74 percent), and more than half believe
immunizations to be safe (60 percent). However, their views on the anthrax
immunization program and potential biological warfare immunizations in the
future are very different. For example, two out of three reported little or
no support for the anthrax program
(65 percent). Despite DOD's high-visibility campaign to educate
servicemembers about the anthrax immunization program, only about one in
four believes that the information provided on DOD's anthrax Web site is
timely (25 percent), 19 percent believe it to be complete, and 17 percent
believe it to be accurate. Just 1 in 10 (11 percent) believe the information
to be unbiased. Further, three out of four indicated they would not or
probably would not take the shots if the anthrax immunization program were
voluntary (76 percent). Eighty-seven percent, or almost 9 out of 10,
indicated they would or probably would have safety concerns if additional
vaccines for other biological warfare agents were added to the military
immunization program.

Forty-two percent of the respondents reported that they had received one or
more anthrax shots. Of those taking the shots, 86 percent reported
experiencing some type of local or systemic reactions, for example, a knot
in the arm or joint pain. For some reactions, the reported duration was more
than 7 days (for example, limited arm/body motion and joint pain). Some of
these reactions could have implications for work performance. About
one-third (36 percent) reported that they had been provided information
concerning what action to take in the event of side effects or reactions.
But 71 percent reported being unaware of the Food and Drug Administration's
Adverse Events Reporting System which is a passive surveillance system to
alert the Food and Drug Administration and the Center for Disease Control
and Prevention of adverse events that may be associated with licensed
vaccines. Further, about 60 percent of those experiencing reactions had not
discussed them with military health care personnel or their supervisorssome
citing fear of the loss of flight status, possible adverse effects on their
military or civilian careers, and ridicule as reasons for nondisclosure (49
percent).

Background

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In December 1997, the Secretary of Defense announced that all U.S. forces
would be inoculated against the potential use of anthrax on the battlefield.
In August 1998, DOD began immunizing its 2.4 million U.S. military
personnelincluding active and reserve component personnelwith a licensed
anthrax vaccine. This program is mandatory. Some members of the armed forces
have expressed concerns regarding the safety and efficacy of the anthrax
vaccine. Those refusing the vaccine have been disciplined under
service-specific policies for disobeying a lawful order. Anecdotal
information suggests that an unknown number of Reservists and National Guard
members have resigned or transferred to units or non-flying positions that
do not require anthrax vaccinations at this time. DOD does not collect
uniform records on such changes in status.

Congress and the Department of Defense have become increasingly concerned
about the readiness of U.S. armed forces. Key reasons for this concern are
the increasing pace (tempo) of operations due to deployments, parts
shortages and maintenance backlogs, and past problems in recruiting and
retaining quality people. The reserve components are experiencing
difficulties in filling their ranks with new recruits at a time when DOD is
relying on them more heavily to support operations around the world.
Specifically, the retention of pilots and other aircrew members has been and
continues to be a problem that could impact readiness. The impact of an
exodus of Guard and Reserve pilots and aircrew members would be significant.
Without adequate numbers of pilots and aircrew, the Guard and Reserve could
not support the active force in its worldwide operations. In addition, it
costs the military an average of almost $6 million to train and develop a
fully qualified experienced aviator, which the Air Force suggests takes
about 9 years.

Anthrax Is a Key Factor Affecting Individual Decisions to Change Military
Status

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Twenty-five percent of the pilots and aircrew members of the Guard and
Reserve we surveyed have transferred to another unit, left the military, or
moved to inactive status. Of these, 25 percent ranked anthrax immunization
as the most important factor influencing their decision to leave or transfer
followed by other employment opportunities at 16 percent and family reasons
at 16 percent. The general military immunization program was cited as the
least important reason for a change in their military duty status. Further,
about one in five (18 percent) left before they had qualified for a military
retirement. Forty-three percent of those who separated or are no longer in
military flying status because of the anthrax program indicated that they
would or probably would consider returning to a unit or to military flying
status if the anthrax vaccination program were not mandatory.

Of those who are still in Guard and Reserve units, 18 percent reported that
they planned to leave the military within the next 6 months. Again, when
asked to rank the most important factor for their decision to leave, the
anthrax immunization was the most frequently reported reason
(61 percent), followed by heavy unit workload and family reasons. Each of
these groups (that is, those who left and those who intend to leave) had in
excess of 3,000 flight hours, which symbolizes a seasoned and experienced
workforce.

Anthrax Vaccine Immunization Program Is Not Widely Supported

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Most Guard and Reserve pilots and aircrew members support immunization
programs in general; however, relatively few appear to support the anthrax
program or future immunization programs for other biological warfare agents.
Almost three out of four (74 percent) of the pilots and aircrew members of
the Guard and Reserve believe that immunizations in general are moderately
to very effective, and 60 percent believe that immunizations are moderately
to very safe. On the other hand, 65 percent, or two out of three
servicemembers, reported little or no support for the anthrax immunization.

DOD has employed a high-visibility campaign to educate servicemembers about
the program and has taken steps to address the controversy surrounding the
program. In addition, it expanded its communications efforts by updating the
program's Internet site, opening a toll-free anthrax information line and
forming a speakers' bureau of anthrax experts. DOD also updated briefings
for installation leaders and medical personnel to provide more detailed
information on the anthrax threat. We had previously reported in October
1999 that servicemembers were not satisfied with the information provided to
them. In our current survey, relatively few respondents reported being
moderately to very satisfied with the information provided at the DOD Web
site. For example, only
19 percent were satisfied with the completeness of the information
17 percent were satisfied with the information's accuracy, and 25 percent
were satisfied with its timeliness. Just 11 percent were satisfied that the
information was unbiased.

In terms of all information provided by DOD to servicemembers on the anthrax
program through the Web site and other sources, 39 percent indicated that
they were moderately to very satisfied with the information provided on the
military anthrax threat. On the other hand, only 12 percent were moderately
to very satisfied with the information received about the vaccine's
long-term safety.

Seventy-six percent of survey respondents indicated that they would not or
probably would not take the shots if the anthrax immunization program were
voluntary. Just 11 percent reported they would or probably would take the
shot on a voluntary basis. About 13 percent were uncertain. Further, 87
percent reported that they would or probably would have concerns about
safety if additional vaccines for other biological warfare agents were added
to military immunization requirements.

Most Adverse Events to Anthrax Immunizations Are Not Reported [0x08 graphic]

Adverse events are adverse outcomes for which a cause and effect
relationship with an exposure (to a vaccine or a medication) has not yet
been determined. DOD has used data from the Vaccine Adverse Event Reporting
System to monitor adverse events (or reactions) to anthrax vaccinations. It
is a passive surveillance system, which relies on vaccine recipients or
their health care providers to report any adverse events after receiving the
vaccine. Studies show that significantly fewer adverse events are reported
under a passive system when compared to an active surveillance system in
which vaccine recipients are actively monitored to identify and track any
adverse reactions to a vaccine.

Forty-two percent of the respondents reported that they had received one or
more anthrax shots. Of these, 86 percent reported experiencing side effects
or adverse reactions. About 60 percent indicated that they had not discussed
any side effect to the anthrax vaccine with military health care personnel
or their supervisorssome (49 percent) citing as their reasons fear of losing
their flight status, adverse effects on their military or civilian careers,
and ridicule. Seventy-one percent reported that they were unaware of the
Food and Drug Administration's Vaccine Adverse Events Reporting System.
Slightly less than 6 percent of those who had a reaction reported to this
system.

Our survey showed that for some local and systemic reactions (for example, a
knot or lump in the vaccinated arm and joint pain), the reported duration
was more than 7 days. (See table 1 in app. II for a list of reported
reactions). The prevalence and duration of the reported symptoms varied
widely. A number of reported symptoms are expected reactions to the anthrax
vaccine; however, their frequency and duration was more than DOD reported
(0.007 percent). For example, two out of three reported burning in the
vaccinated arm (79 percent) and a knot or a lump in the vaccinated arm (82
percent). Also, 10 percent reported swelling in the arm lasting for more
than 7 days, and 6 percent reported arm pain and limited motion for more
than 7 days. Six percent reported extreme fatigue, and 7 percent reported
joint pain lasting for more than
7 days.

These reported reactions are significant because they could potentially
impact individual ability to carry out military duties. However, 60 percent
of those who experiencing reactions had not discussed them with military
health care personnel or their supervisors. Forty-nine percent did not
report because the reactions were not severe enough; however, another
49 percent did not report because of the fear of losing flight status,
possible adverse effects on their military and civilian careers, and a fear
of ridicule. Since many individuals are not reporting their reactions to
military medical personnel or to the Vaccine Adverse Events Reporting
System, the actual duration, the extent or impact on units and individuals,
and the ultimate resolution of these reactions are unknown.

Because we had limited time to analyze all of the data we obtained, we will
provide additional detailed analyses of the data to the Committee in a later
report. Other issues such as impact of anthrax vaccine program on morale and
quality of life will also be addressed in that report.

Mr. Chairman, this concludes my prepared statement. I would be happy to
answer any questions you have at this time.

Contacts and Acknowledgments

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For future questions regarding this testimony, please contact Kwai-cheung
Chan at (202) 512-3652. Other individuals making key contributions to this
testimony includes Sushil K. Sharma, Ph.D., DrPH, Foy D. Wicker and Stanley
J. Kostyla.

Appendix I

Scope and Methodology

The best way to reliably assess the pulse and views of military members is
by surveying a representative sample of personnel. This year, we developed
and administered such a survey that was designed to obtain the views of
selected Air National Guard and Air Force Reserve personnel regarding issues
associated with the DOD's Anthrax Vaccine Immunization Program (AVIP). The
survey was mailed in May 2000 to a random sample of 1,258 personnel. As of
September 7, 2000, 829 individuals had completed and returned the survey.
Our work was conducted in accordance with generally accepted government
auditing standards.

Questionnaire Development

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The survey was developed with the assistance of discussion groups made up of
pilots and other aircrew members of the Air National Guard and Air Force
Reserve. It was pretested at Andrews Air Force Base, Maryland, and further
pretested and refined at Guard and Reserve units located in Hartford,
Connecticut; Newburg, New York; Madison, Wisconsin; Battle Creek Michigan;
Memphis, Tennessee; Travis Air Force Base, California; March Air Force
Reserve Base, California; Fort Wayne, Indiana; and, Dover, Delaware

Sample Construction

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The sample consisted of 1,253 Air National Guard and Air Force Reserve
aircrew personnel who were in the service at any time between September 1998
and February 2000. Our sample was drawn from pilot and aircrew member
populations provided by the Air National Guard and Air Force Reserve in
early 2000. In addition the Anthrax Vaccine Immunization Program Office
provided information as to vaccination status. For the sample design,
personnel in our universe were categorized by two factors: military status
(left versus on board) and vaccine status (shot versus no shot). The sample
was adjusted for groups with differing expected rates of survey completion
and adjusted to provide a level of precision of
+ 7 percentage points.

Survey Administration

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As of September 7, 2000, we had received 828 responses from eligible
respondents, an overall response rate of 66 percent. We used a contractor to
create a database based on reported responses. We validated the data
provided to us by the contractor to ensure accuracy.

Weighting Responses and Potential Nonresponse Bias

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The survey responses were weighted to reflect the Air National Guard and Air
Force Reserve population for the survey. This weighting procedure adjusts
for the different proportions of individuals sampled from each cell and the
actual response rate for that cell in the sample design. The survey results
assume that nonrespondents would have answered like respondents. This
assumption involves some unknown risk of nonresponse bias. Weighting can be
used to statistically adjust for differing sampling rates and response
rates; however, weighting cannot adjust for possible differences between
those who do and those who do not respond to a survey.

Appendix II

Prevalence of Local and Systemic Adverse Reactions by Duration
 Type of reaction       < 1 Day     1-3 Days     4-7 Days          > 7 Days Total
 Local                  Percent      Percent    Percent   Percent    Percent
 Redness 2.5 inches or
 less                   21           20         7         5          53
 Redness >2.5 inches    5            12         10        6          33
 Swelling in arm        16           18         11        10         55
 Burning in arm         60           14         3         2          79
 Arm Pain limited
 motion                 20           22         11        6          59
 Itching in arm         18           10         7         5          40
 Knot/lump in arm       17           14         21        30         82
 Systemic
 Chills                 5            4          3         1          13
 Fever                  7            6          2         1          16
 Extreme fatigue        6            7          3         6          22
 Dizziness              1            2          1         1          5
 Headaches              6            6          2         1          15
 Blurred vision         1            1          0         1          3
 Numbness in
 extremities            3            1          1         2          7
 Joint pain             6            5          5         7          23
 Memory loss            1            1          1         2          5
 Blackouts              0            0          0         0          0
 Ringing in ears        2            1          1         2          6
 Insomnia               1            1          2         1          5
 Nausea                 3            2          2         0          7
 Other                  1            1          2         3          7

Source: GAO Survey, 2000.

Related GAO Products

Gulf War Illnesses:Questions About the Presence of Squalene Antibodies in
Veterans Can Be Resolved (GAO/NSIAD-99-5, Mar. 29, 1999).

Medical Readiness: Safety and Efficacy of the Anthrax
(GAO/T-NSIAD-99-148, Apr. 29, 1999).

Contract Management: Observations on DOD's Financial Relationship with the
Anthrax Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999).

Medical Readiness: Issues Concerning the Anthrax Vaccine
(GAO/T-NSIAD-99-226, July 21, 1999).

Anthrax Vaccine: Safety and Efficacy Issues (GAO/T-NSIAD-00-48,
Oct. 12, 1999).

Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax Vaccine
Immunization Program (GAO/-NSIAD-00-36, Oct. 1999).

Medical Readiness: DOD continues to Face Challenges in Implementing Its
Anthrax Vaccine Immunization Program (GAO/T-NSIAD-00-157,
Apr. 2000).

(713048)

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Orders by Internet

For information on how to access GAO reports on the Internet, send an e-mail
message with info in the body to:

[email protected]

or visit GAO's World Wide Web home page at:

http://www.gao.gov

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Contact one:

Web site: http://www.gao.gov/fraudnet/fraudnet.htm

E-mail: [email protected]

1-800-424-5454 (automated answering system)

We have previously reported on a number of concerns regarding the safety and
efficacy of the anthrax vaccine and other related matters. (See appendix
III).

Medical Readiness: DOD Faces Challenges in Implementing Its Anthrax Vaccine
Immunization Program (GAO/NSIAD-00-36, October 1999).
*** End of document. ***