Index


Medical Readiness: Issues Concerning the Anthrax Vaccine (Testimony,
07/21/1999, GAO/T-NSIAD-99-226).

Pursuant to a congressional request, GAO discussed the results of its
work on the anthrax vaccine, focusing on: (1) the extent to which data
support the need for six initial shots and an annual booster of the
anthrax vaccine; (2) the relative merits and weaknesses of a passive
surveillance system in determining adverse events; (3) the available
data on differences in adverse reaction rates between men and women
receiving the anthrax vaccine; and (4) the disadvantages of the vaccine
and the status of federal efforts to develop an improved anthrax
vaccine.

GAO noted that: (1) no studies have been done to determine the optimum
number of doses of the anthrax vaccine; (2) a study done during the
early 1950s showed that animals could be protected against cutaneous
anthrax using a three-dose schedule; (3) however, the number of doses
was increased to six when three people who had received three doses of
the vaccine were infected after exposure to anthrax; (4) in a study of
the vaccine's human efficacy published in 1962, a six-dose schedule was
used, and the researchers concluded that the vaccine provided protection
against cutaneous exposure to anthrax; (5) in 1998, the manufacturer of
the vaccine submitted a Food and Drug Administration (FDA) application
to determine whether the number of shots in the initial schedule could
be reduced from six to five; (6) although annual boosters are given, the
need for this frequency and the amount of the booster dose has also not
been evaluated; (7) Department of Defense (DOD) submits data on adverse
events associated with the anthrax vaccine to the Vaccine Adverse Events
Reporting System; (8) this system has several advantages; (9) it alerts
FDA and Centers for Disease Control and Prevention (CDC) to previously
unreported or unexpected increases in reported adverse events; (10) it
is also a relatively affordable way to supplement the data collected on
vaccines before they are licensed; (11) however, it is a passive
surveillance system, which means that FDA and CDC must rely on vaccine
recipients or their health care providers to report any adverse events
after receiving the vaccine; studies show that adverse events are
reported significantly less than they would be in an active surveillance
system; (12) DOD has conducted three efforts to actively collect data on
adverse reactions after servicemembers received the anthrax vaccine;
(13) data from these efforts show that women reported twice the rate of
adverse reactions than men for both local and systemic reactions; (14) a
higher proportion of women than men reported making an outpatient
medical visit after a vaccination, and more than twice the percentage of
women reported that they missed one or more duty shifts after their
vaccinations than did men; (15) the anthrax vaccine has several
disadvantages; (16) the amount of protective antigen in the vaccine
cannot be precisely measured, and it varies from lot to lot; and (17)
also, the requirement for a six-dose schedule and annual booster shots,
rather than a smaller number of doses, complicates the logistics of
inoculating all of DOD's troops and increases the cost of the vaccine
program.

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

 REPORTNUM:  T-NSIAD-99-226
     TITLE:  Medical Readiness: Issues Concerning the Anthrax Vaccine
      DATE:  07/21/1999
   SUBJECT:  Immunization services
	     Biological warfare
	     Chemical warfare
	     Data collection
	     Safety standards
	     Public health research
	     Military personnel
	     Product safety
IDENTIFIER:  CDC/FDA Vaccine Adverse Events Reporting System
	     DOD Anthrax Immunization Program

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ns99226t GAO United States General Accounting Office

Testimony Before the Subcommittee on National Security, Veterans'
Affairs, and International Relations, Committee on Government
Reform, House of Representatives

For Release on Delivery Expected at 10: 00, a. m., EDT Wednesday,

July 21, 1999 MEDICAL READINESS

Issues Concerning the Anthrax Vaccine

Statement of Kwai- Cheung Chan, Director Special Studies and
Evaluations, National Security and International Affairs Division

GAO/T-NSIAD-99-226

  GAO/T-NSIAD-99-226

Page 1 GAO/T-NSIAD-99-226

Mr. Chairman and Members of the Subcommittee: We are pleased to be
here today to share the results of our work on the anthrax
vaccine. As you know, questions have been raised about the
Department of Defense's (DOD) anthrax immunization program because
of concerns related to (1) the safety and efficacy of the vaccine
and (2) problems found over the past few years by the Food and
Drug Administration (FDA) during its inspection of the facility
that was manufacturing the vaccine. We reported our findings on
these issues to you in previous testimonies. 1 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. Although a version of the anthrax vaccine was shown
to be effective against cutaneous exposure, the vaccine has not
been tested against inhalation anthrax in humans. DOD has
recognized that some of the concerns about using the current
vaccine might be mitigated in the future through actions such as
testing and research and adjustments to the program based on new
data.

As requested, we will discuss (1) the extent to which data support
the need for six initial shots and an annual booster of the
anthrax vaccine, (2) the relative merits and weaknesses of a
passive surveillance system in determining adverse events, 2 (3)
the available data on differences in adverse reaction rates
between men and women receiving the anthrax vaccine, and (4) the
disadvantages of the current vaccine and the status of federal
efforts to develop an improved anthrax vaccine.

Results in Brief No studies have been done to determine the
optimum number of doses of the anthrax vaccine. A study done
during the early 1950s showed that animals could be protected
against cutaneous anthrax using a three- dose schedule. However,
the number of doses was increased to six when three people who had
received three doses of the vaccine were infected after exposure
to anthrax. In a study of the vaccine's human efficacy published

1 Medical Readiness: Safety and Efficacy of the Anthrax Vaccine
(GAO/T-NSIAD-99-148, Apr. 29, 1999) and Contract Management :
Observations on DOD's Financial Relationship With the Anthrax
Vaccine Manufacturer (GAO/T-NSIAD-99-214, June 30, 1999).

2 Clinical events reported to a passive surveillance system are
usually termed adverse events rather than adverse reactions
because causally- related events to the vaccine is not usually
possible. Lett er

Page 2 GAO/T-NSIAD-99-226

in 1962, a six- dose schedule was used, and the researchers
concluded that the vaccine provided protection against cutaneous
exposure to anthrax. 3 In 1998, the current manufacturer of the
vaccine submitted an FDA application (Investigational New Drug) to
determine whether the number of shots in the initial schedule
could be reduced from six to five. Although annual boosters are
given, the need for this frequency and the amount of the booster
dose has also not been evaluated.

DOD submits data on adverse events associated with the anthrax
vaccine to the Vaccine Adverse Events Reporting System (VAERS). 4
This system has several advantages. It alerts FDA/ CDC to
previously unreported or unexpected increases in reported adverse
events. It is also a relatively affordable way to supplement the
data collected on vaccines before they are licensed. However, it
is a passive surveillance system, which means

that FDA/ CDC must rely on vaccine recipients or their health care
providers to report any adverse events after receiving the
vaccine; studies show that adverse events are reported
significantly less than they would be in an active surveillance
system. In an active system, which is generally more costly to
administer, vaccine recipients are monitored to find out if they
had any adverse events after being inoculated.

In addition to reporting data to VAERS, DOD has conducted three
efforts to actively collect data on adverse reactions after
servicemembers received the anthrax vaccine. Data from these
efforts show that women reported twice the rate of adverse
reactions than men for both local (e. g., swelling) and systemic
(e. g., malaise and chills) reactions. In addition, a higher
proportion of women than men reported making an outpatient medical
visit after a vaccination, and more than twice the percentage of
women reported

that they missed one or more duty shifts after their vaccinations
than did men.

The anthrax vaccine has several disadvantages. The amount of
protective antigen in the vaccine cannot be precisely measured,
and it varies from lot to lot. Also, the requirement for a six-
dose schedule and annual booster

shots, rather than a smaller number of doses, complicates the
logistics of inoculating all of DOD's troops and increases the
cost of the vaccine program. Knowledge of anthrax infection and
studies of experimental 3 P. S. Brachman et al., Field evaluation
of a human anthrax vaccine, American Journal of Public Health,
vol. 52 (1962), pp. 632- 645.

4 The system is an FDA/ Centers for Disease Control and Prevention
(CDC) system.

Lett er

Page 3 GAO/T-NSIAD-99-226

anthrax vaccines indicate that a second- generation vaccine with a
more precise amount of protective antigen could be developed and
that fewer doses of the vaccine would be required. However, a
second- generation vaccine has not been fully tested, and the
testing required for licensing alone would take about 3 years. FDA
approval of the manufacturing of the vaccine would take longer. In
1995, the U. S. Army Medical Research Institute of Infectious
Diseases (USAMRIID) 5 developed a second- generation recombinant
vaccine (that is, a vaccine produced through DNA extraction)
against anthrax. The vaccine was tested on

animals, but clinical trials were not conducted in humans. DOD
currently considers such a vaccine an unfunded requirement. The
Department of Health and Human Services recently funded several
active research grants to develop a second- generation recombinant
vaccine because of a

perceived growing bioterrorism concern. In developing a new
vaccine, researchers also believe they should consider the impact
of new and engineered strains of anthrax.

Background DOD currently plans to vaccinate all 2. 4 million
servicemembers against anthrax using the vaccine licensed in 1970
by the Division of Biologics Standards, National Institutes of
Health (NIH). As of July 14, 1999, more

than 300,000 servicemembers had received at least one dose of the
vaccine. Initial immunization consists of three shots given at 0,
2, and 4 weeks followed by three additional shots given at 6, 12,
and 18 months. Some studies have been done on the short- term
effects of the licensed vaccine. We previously testified that the
number of adverse reactions reported in these studies partly
depended on whether an active or passive surveillance system was
used to monitor adverse reactions. 6 Also, we reported that the
long- term safety of the vaccine has not been investigated but
that DOD is considering a study to examine long- term effects of
the vaccine.

5 USAMRIID, an organization of the U. S. Army Medical Research and
Materiel Command, conducts research to develop strategies,
products, information, procedures, and training programs for
medical defense against biological warfare threats and naturally
occurring infectious diseases that require special containment. It
is located at Fort Detrick, Maryland. 6 Medical Readiness (GAO/T-
NSIAD-99-148, Apr. 29, 1999).

Page 4 GAO/T-NSIAD-99-226

Data on the Need for Six Shots Are Not Available

The original inoculation schedule of three doses was based on a
regimen developed using animals in the early 1950s. However, three
people (two in Fort Detrick and one in a private wool mill) who
received three doses of

the vaccine became infected after exposure to anthrax. The number
of doses was then increased to six for the human efficacy study
published in 1962. The study did not provide enough information to
determine whether the vaccine was effective against inhalation
anthrax. There were no studies done to determine the optimum
number of doses of the vaccine. Also, according to DOD
researchers, the choice of six doses was arbitrary. The license
for the vaccine, which was granted to the Michigan Department of
Public Health (MDPH), 7 calls for the six- dose schedule and
annual boosters used in the human efficacy study, and DOD has
followed this regimen. In September 1998, BioPort submitted to FDA
an application (Investigational New Drug) to determine whether the
number of shots in the initial schedule could be reduced from six
to five. In November 1971, the Division of Biologics Standards,
NIH, noted an apparent increase in reports of adverse reactions
after individuals received booster shots. The Division considered
it advisable to reevaluate the need for annual boosters and
possibly the amount of the booster dose. Although the record is
unclear as to whether or not NIH requested a reevaluation, to
date, no such reevaluation has been done.

The Relative Merits and Weaknesses of Passive Surveillance Systems
in Determining Adverse Events

DOD submits data on adverse events associated with the anthrax
vaccine to VAERS. VAERS is a passive surveillance system to alert
FDA and CDC of adverse events that may be associated with licensed
vaccines. Information

is voluntarily reported to VAERS by health care providers,
patients, or families, who are encouraged to report any adverse
events after a person receives a vaccine.

VAERS has several advantages. It is a relatively affordable way to
supplement data on short- term adverse events that are collected
using active means during the clinical trials before a vaccine is
licensed. Most important, however, VAERS serves as a signal for
the detection of previously unreported adverse events and/ or
unexpected increases in

7 MDPH was granted the original license to produce the anthrax
vaccine. In 1995, the facility changed its name to the Michigan
Biologic Products Institute. In 1998, the facility was sold, and
its name was changed to BioPort.

Page 5 GAO/T-NSIAD-99-226

reported events. Prelicensing clinical trials are limited in
detecting the range of adverse reactions because of the small
samples, short durations, and the homogeneous population used as
subjects. In addition, both the general public and doctors can
report adverse events to the system, and the data is open to
public scrutiny.

VAERS also has several disadvantages. Studies show that adverse
events are often underreported in a passive surveillance system. 8
A former FDA commissioner acknowledged the underreporting of
adverse events in passive surveillance systems and cited one study
showing that only about 1 percent of serious events attributable
to drug reactions are reported to FDA. 9 Reporting of adverse
events appears to depend on several factors,

such as the clinical seriousness of the event, the length of time
between the shots and the event, and health care workers'
awareness of and obligation to report particular adverse events.
Also, outcomes with delayed onset after vaccination or outcomes
not generally recognized to be associated with vaccination are
often underreported. According to the National

Vaccine Information Center, there is no mechanism within VAERS for
a 1-, 3-, or 10- year follow- up to evaluate vaccine reactions
that have a long latency period. According to CDC, the limitations
of VAERS data suggest it is not a valid source for assessing the
rate of adverse events.

In an active surveillance system, health care workers monitor
people that have been vaccinated to find out if they have had
adverse reactions. Such systems are generally used during clinical
trials and are more costly to administer than passive systems
because of the additional infrastructure and personnel required.
However, such systems are sometimes used to obtain information
when questions arise about the safety of a vaccine after
licensing.

8 S. Rosenthal and R. Chen, The Reporting Sensitivities of Two
Passive Surveillance Systems for Vaccine Adverse Events, American
Journal of Public Health, vol. 85 (1995), pp. 1706- 1709; R. T.
Chen et al., The Vaccine Adverse Event Reporting System (VAERS),
Vaccine, vol. 12 (1994), pp. 542- 550; and

R. T. Chen, Special Methodological Issues in Pharmacoepidemiology
Studies of Vaccine Safety, Ed. B. L. Strom, Pharmacoepidemiology
(Chicester: John Wiley and Sons, 1994).

9 D. A. Kessler, Introducing MEDWatch: A New Approach to Reporting
Medication and Devise Adverse Effects and Product Problems,
Journal of the American Medical Association, vol. 269 (1993), pp.
2765- 2768, and H. D. Scott, et al., Rhode Island Physicians'
Recognition and Reporting of Adverse Drug Reactions, Rhode Island
Medical Journal, vol. 70 (1987), pp. 311- 316.

Page 6 GAO/T-NSIAD-99-226

Women Report More Adverse Reactions Than Men

In addition to DOD's reporting of adverse events to VAERS, DOD has
conducted three efforts to actively collect data that can be used
to examine gender differences in adverse reactions after
servicemembers have received the anthrax vaccine. The first
effort, conducted by USAMRIID, included data on shots given at
Fort Detrick during 1977- 96. The second

effort, conducted in 1999 by a DOD physician stationed in Korea,
was a survey given to servicemembers when they reported for their
initial six- dose schedule of shots; it asked questions about
their reactions to the previous shot. Results from this effort
reflect the researcher's preliminary analysis of the data. The
third effort, conducted in 1998- 99 at Tripler Army Medical
Center, Hawaii, included a survey on adverse reactions to the
first three shots when individuals reported for their fourth shot
and later

included a follow- up survey on adverse reactions to the fourth
shot. None of the efforts used a control group. Also, all three
relied on self- reported data and were not adjusted for factors
such as occupation, physical activity level, and age. Because of
differences in the way data were collected, reaction rates are not
strictly comparable among the different efforts.

According to the data gathered in all three efforts, a higher
proportion of females reported reactions to the anthrax vaccine
than did their male counterparts. Tables 1 and 2 summarize the
rates of reported reactions to the vaccine during the two efforts
at Fort Detrick and in Korea. The researchers at Fort Detrick
determined that the statistical difference was significant 10 in
the reported reaction rates of males and females after their
second and subsequent shots. The researchers for the other two
efforts did not report whether the difference in reported reaction
rates was statistically significant. 10 Tests of significance deal
with the question of whether a difference is real or just a chance
variation. It

does not deal with the question of how important the difference is
or what caused the difference. The test does not check the design
of the study. If a test is significant at the 99- percent level,
the results could be due to chance 1 percent of the time.

Page 7 GAO/T-NSIAD-99-226

Table 1: Gender Differences in the Reported Rate of Reactions to
the Anthrax Vaccine, From Fort Detrick Data (1977- 96)

Note: As a result of GAO's recalculation, the percentages reflect
minor differences from those reported by the researcher. a The
gender difference in reported reaction rates is statistically
significant at the 99- percent

confidence level. b The gender difference in reported reaction
rates is statistically significant at the 99.99- percent

confidence level. Source: DOD.

Table 2: Preliminary Data on Gender Differences in the Reported
Rate of Reactions to the Anthrax Vaccine, From Korea Survey (1999)

Note: This represents a preliminary analysis of the data by the
researcher, and at the time of our review, data on reactions to
the third shot were not available. Source: DOD.

The data gathered in Korea shows that after the first two shots,
more than twice the proportion of women reported the systemic
reactions of fever, malaise, or chills than men (see table 3).

Dose number Males percent (number of doses) Females percent

(number of doses)

First 3. 75 (1, 013) 3. 86 (259) Second 3.06 a (979) 7. 29 a (247)
Third 1. 71 a (938) 5. 06 a (237) Fourth and subsequent 3. 40 b
(5062) 7. 06 b (737)

Dose number Males percent (number of doses) Females percent

(number of doses)

First 42.1 (2036) 71. 6 (495) Second 44. 4 (1953) 74. 0 (474)

Page 8 GAO/T-NSIAD-99-226

Table 3: Preliminary Data on Gender Differences in Systemic
Reactions, From Korea Survey (1999)

Note: This represents a preliminary analysis of the data by the
researcher, and at the time of our review, data on reactions to
the third dose were not available. Source: DOD.

The Tripler effort also demonstrates gender differences in
reported reactions (see table 4). These data show that a higher
proportion of women reported making an outpatient visit after a
vaccination than their

male counterparts. In addition, more than twice the proportion of
women reported that they missed one or more duty shifts after
their vaccinations than did males.

Numbers in percent

Fever Malaise Chills Dose number Male Female Male Female Male
Female

First 0. 9 2.8 6. 0 15. 6 1.5 5. 5 Second 1.7 4. 8 7.1 15.4 1. 9
4. 0

Page 9 GAO/T-NSIAD-99-226

Table 4: Gender Differences in Reported Local Reactions,
Outpatient Medical Visits, and Missed Duty, From Tripler Army
Medical Center Survey (1998- 99)

Note: Between 421 and 471 men and between 74 and 83 women
responded to each question on the survey. a Data were not
available. Source: DOD. Numbers in percent

Reaction Dose 1 Dose 2 Dose 3 Dose 4 Moderate to severe redness

Male Female 17.5 49.1 20. 4

46. 9 17. 2 51. 4 31. 6

39. 8

Swelling of lower arm

Male Female 9.7

13.4 9.5 13. 5 9.2

13. 0 7.1 8.4

Pain limiting motion of elbow

Male Female 9.7 17.1 8.7

13. 5 7.6 11. 7 7.9

8.6

Localized itching

Male Female 25.2

62.6 25. 7 60. 4 24. 5

57. 9 27. 7 39. 2

Lump or knot

Male Female 63.9

89.9 64. 4 87. 8 60. 5

83. 6 65. 5 73. 2

Muscle soreness

Male Female 66.6

79.7 64. 7 76. 4 61. 8

70. 8 60. 4 61. 6

Outpatient medical visit

Male Female 5.3

10.0 2.0 13. 8 2.7

3.9 a

Missed one or more shifts of duty

Male Female 2.2

5.0 2.0 5.1 0.9

3.9 a

Page 10 GAO/T-NSIAD-99-226 Status of Federal Efforts to Develop a

Second- Generation Anthrax Vaccine

According to researchers and the Institute of Medicine of the
National Academy of Sciences, the current anthrax vaccine has
several disadvantages. 11 The amount of protective antigen in the
vaccine is variable from lot to lot because the manufacturing
process cannot precisely quantify the antigen. 12 Also, there is
some evidence that the current anthrax vaccine may have diminished
efficacy against certain virulent strains of anthrax ( Bacillus
anthracis). And the required six- dose schedule

and annual boosters complicate the logistics of inoculating all of
DOD's troops and increase the cost of the vaccine program.
According to DOD research, a second- generation recombinant
vaccine created with a process that is fully defined, quantified,
and controlled in terms of protective antigen, can be developed
and that fewer doses could be required. 13 DOD research also shows
that a recombinant vaccine could be created using modern
techniques to produce highly purified protective antigen. This
process not only would remove unwanted bacterial proteins but also
would enable precise amounts of the purified protective antigen to
be incorporated into the vaccine. A further potential benefit is
that,

compared to the current vaccine, the protective antigen could be
produced in a nonspore- forming organism. As a result, according
to DOD officials, manufacturers could use their buildings and
equipment to produce the

anthrax vaccine as well as other vaccines. In 1995, USAMRIID
developed a new recombinant protective antigen vaccine against
anthrax. This vaccine was successfully tested in experiments using
animals but has not been tested on humans. USAMRIID officials
stated that this testing would take about 3 years, and FDA
approval of the manufacturing of the vaccine could take years
longer. DOD

considers further development of this vaccine candidate an
unfunded requirement. In response to the perceived threat of
bioterrorism, the

11 P. S. Brachman and A. Friedlander, Anthrax, Vaccines, ed. S. A.
Plotkin and E. A. Mortimer, Jr., (Philadelphia: W. B. Saunders
Company, 1994), p. 737, and Chemical and Biological Terrorism:
Research and Development to Improve Civilian Medical Response,
Institute of Medicine (Washington, D. C.: National Academy Press,
1999), p. 135.

12 Chemical and Biological Terrorism: Research and Development to
Improve Civilian Medical Response, Institute of Medicine
(Washington, D. C.: National Academy Press, 1999), p. 135. 13 B.
Ivins et al., Immunization Studies with attenuated strains of
Bacillius anthracis, Journal of Infection and Immunity, vol. 52
(1986), pp. 454- 458; B. E. Ivins, The Search for a New-
Generation Human Anthrax Vaccine, Clinical Immunology Newsletter,
vol. 9 (1988), pp. 30- 32; and Y. Singh et al., Study of
Immunization Against Anthrax with the Purified Recombinant
Protective Antigen of Bacillus anthracis, Journal of Infection and
Immunity, vol. 66 (1998), pp. 3447- 3448.

Page 11 GAO/T-NSIAD-99-226 Department of Health and Human
Services' National Institute of Allergy and Infectious Diseases
formed a working group to develop and test a

second- generation anthrax vaccine. The Institute recently funded
several active research grants in this regard.

In developing a second- generation recombinant anthrax vaccine,
researchers believe they will need to address the additional
problem of whether strains of deliberately engineered or naturally
occurring anthrax

can overcome the protective immunity of such a vaccine. A
variation in virulence among anthrax strains and a variation in
relative resistance to vaccine- induced immunity has been observed
in experiments on animals. However, the reasons for the variation
have not been scientifically proven.

Mr. Chairman, this concludes my formal statement. If you or other
members of the Subcommittee have any questions, we will be pleased
to answer them.

Contacts and Acknowledgments

For future contacts regarding this testimony, please contact Kwai-
Cheung Chan at 512- 3652. Individuals making key contributions to
this testimony included Sushil Sharma, Howard Deshong, and Nancy
Ragsdale.

(713043) Lett er

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