THE ANTHRAX VACCINE DEBATE: 

A MEDICAL REVIEW FOR COMMANDERS

by 

Richard A. Hersack, Col, USAF, MC, CFS 

The Counterproliferation Papers 

Future Warfare Series No. 10 

USAF Counterproliferation Center 

Air War College 

Air University 

Maxwell Air Force Base, Alabama 

The Anthrax Vaccine Debate: 

A Medical Review for Commanders 

Richard A. Hersack, Col, USAF, MC, CFS 

April 2001 

The Counterproliferation Papers Series was established by the USAF 

Counterproliferation Center to provide information and analysis to assist 

the understanding of the U.S. national security policy-makers and USAF 

officers to help them better prepare to counter the threat from weapons of 

mass destruction. Copies of No. 10 and previous papers in this series are 

available from the USAF Counterproliferation Center, 325 Chennault 

Circle, Maxwell AFB AL 36112-6427. The fax number is (334) 953-

7530; phone (334) 953-7538. 

Counterproliferation Paper No. 10 

USAF Counterproliferation Center 

Air War College 

Air University 

Maxwell Air Force Base, Alabama 36112-6427 

The internet address for the USAF Counterproliferation Center is: 

http://www.au.af.mil/au/awc/awcgate/awc-cps.htm 

Executive Summary 

There are two distinct yet related aspects to the debate over the safety and 

efficacy of the anthrax vaccine. 

- An assessment of the clinical safety and efficacy of the anthrax vaccine. 

- The policy level decision to vaccinate military personnel based on 

intelligence reports and assessments. 

- The policy decision to vaccinate is based on an assessment of relative 

risk. 

 -- The risk to an individual of developing side effects and 

complications after vaccination versus, 

 -- The risk that Defense Department (DoD) personnel may be exposed 

to anthrax during an attack. 

Anthrax causes disease in humans through three mechanisms: cutaneous, 

gastrointestinal, inhalation. 

- Cutaneous anthrax occurs primarily in unvaccinated workers in goat hair 

and wool factories. 

- Veterinary practices and vaccination have eliminated anthrax infection 

as an occupational risk. 

- Inhalation anthrax is the most lethal. Death occurs in nearly 100 percent 

of victims with symptoms. 

- Inhalation anthrax is the form most likely to be used in biological 

weapons. 

 -- Requires aerosolization of anthrax spores down to the proper 

particulate size for inhalation. 

 -- Aerosolization of anthrax spores is technically difficult to achieve. 

Anthrax Vaccine, Adsorbed originally developed in the 1950s to vaccinate 

workers exposed to anthrax. 

- Consists of an extract of protective antigen, an anthrax protein that 

stimulates the immune response. 

- Michigan Biological Products Institute (MBPI) took over production in 

the 1960s. 

 -- Produced a purer, more potent version which was licensed for use in 

humans in 1970. 

 -- Licensing was based on clinical studies conducted on both versions 

of the anthrax vaccine. 
 -- Studies done in workers exposed to anthrax showed both versions 

effectively prevent infection. 

Due to the growing threat anthrax may be used in a biological weapon, 

DoD requested increased production. 

- MBPI submitted its plan to the Food and Drug Administration (FDA) to 

expand production facilities. 

- In 1997, Secretary of Defense Cohen issued a directive to vaccinate all 

military personnel. 

- The FDA approved the plans and MBPI stopped production in January 

1998 to begin upgrades. 

- MBPI sold the anthrax vaccine production facilities to BioPort in 

September 1998. 

- The FDA during inspections found several deficiencies in production of 

other vaccines by MBPI. 

 -- These involved primarily the production of rabies vaccine and 

plasma products. 

 -- These deficiencies are unrelated to, and do not involve, the 

production of anthrax vaccine. 

- BioPort has completed facility renovation and has restarted production 

of anthrax vaccine. 

 -- The FDA has not yet certified the new facilities and has not released 

new lots for sale. 

 -- DoD has not used any of these new lots produced by BioPort in its 

vaccination program. 

- DoD has only used lots produced by MBPI before FDA approved 

renovations commenced. 

 -- All lots used by DoD have been tested for potency, purity, and 

sterility and were released by FDA. 

 -- DoD retests each lot for potency, purity, and sterility a second time 

before use. 

Several studies have been conduced on the efficacy of anthrax vaccine for 

preventing anthrax infection. 

- The Brachman study published in 1962 showed anthrax vaccine 

prevented anthrax in wool workers. 

- From 1962 to 1974, the Centers for Disease Control (CDC) collected 

data on vaccinated workers. 
- Between 1974 and 1989, an estimated 68,000 additional doses were 

administered to at-risk workers. 

 -- No vaccinated individuals contracted anthrax infections. 

 -- The rates of side effects and complications remained low, consistent 

with published rates. 

- Animal studies have demonstrated that anthrax vaccine confers 

immunity against inhalation anthrax in most cases. 

- The FDA has stated that use of anthrax vaccine to protect against 

inhalation anthrax is appropriate and consistent with FDA licensing of 

the vaccine and indications listed in the product insert. 

Most side effects from vaccination with anthrax vaccine are mild, local 

reactions, occurring in 30 percent. 

- The incidence of reactions increases with subsequent doses and is higher 

in females. 

- Systemic reactions such as fevers, chills, nausea, are more rare and are 

self-limited. 

- No permanent injuries and no deaths have been associated with the 

administration of anthrax vaccine. 

- Numerous studies, review panels, and ongoing data collection by 

government and civilian agencies continue to document the low 

incidence of side effects associated with administration of anthrax 

vaccine. 

- The incidence of most side effects is actually lower when compared to 

more commonly used vaccines. 

There has been much publicized opposition to the DoD’s anthrax 

vaccination program. 

- Concerns with the vaccination program include: 

 -- Safety and efficacy of the anthrax vaccine in spite of published data. 

 -- Manufacturing, labeling, and storage of anthrax vaccine. 

 -- The FDA licensure of Anthrax Vaccine, Adsorbed. 

 -- Indications for use do not specifically mention vaccination against 

weaponized inhalation anthrax. 

 -- Events surrounding the renovation of the manufacturing facilities. 

 -- Events surrounding the sale of the manufacturing facilities to 

BioPort by MBPI. 

 -- Lack of FDA certification of the renovated BioPort facilities. 
 -- The seemingly high incidence of personnel reporting reactions at 

Dover Air Force Base. 

 -- The presence of trace amounts of squalene. 

 -- Allegations of a connection between use of the anthrax vaccine and 

Gulf War Syndrome (GWS). 

 -- Overstatement of the threat that military personnel could be exposed 

to weaponized anthrax. 

- Factual information available in the medical literature and in published 

testimony before Congress regarding the anthrax vaccine is sufficient to 

alleviate these concerns. 

 -- Numerous studies have documented both the safety and efficacy of 

anthrax vaccine. 

 -- Numerous professional panels and ongoing reviews continue to 

validate the use of anthrax vaccine in humans to protect against 

inhalation anthrax. 

 -- Anthrax Vaccine, Adsorbed is licensed by the FDA and use by the 

military for protection against inhalation anthrax is consistent with 

the approved indications for use listed in the product literature. 

 -- Lots used by DoD were produced before the facility was closed and 

sold to BioPort. 

 -- Lots used by DoD were tested by the FDA, approved for use, and 

retested by the DoD. 

 -- DoD has not used any lots of anthrax vaccine produced by BioPort. 

 -- Among those complaining of symptoms after receiving the anthrax 

vaccine: 

 --- There is no consistent pattern of symptoms. 

 --- The time between vaccination and development of symptoms is 

highly variable. 

 --- In some cases, the incidence of symptoms in these vaccinated 

individuals is less than the incidence of similar symptoms in the 

general population. 

 -- New, more sensitive testing procedures have detected trace amounts 

of squalene. 

 --- The presence of squalene is probably related to the 

manufacturing process. 

 --- Squalene occurs normally in humans at several times the levels 

detected in the vaccine. 
 --- Squalene has never been added to the anthrax vaccine to increase 

potency. 

 -- There is no data supporting a connection between the use of anthrax 

vaccine and Gulf War Syndrome (GWS). 

 -- There is wide consensus that anthrax is the agent most likely to be 

used as a biological weapon. 

The availability of the internet may have promoted the spread of 

objections to the anthrax vaccine. 

- Web sites are able to present material in a biased format without 

objectivity or control. 

- Basically anyone can post anything for any reason without regard for 

accuracy. 

- Commanders and supervisors should consult original documents when 

referring to the world-wide-web. 

There are areas where future generations of anthrax vaccines could be 

improved. 

- Development of a vaccine that requires fewer doses to confer immunity. 

- Development of a reliable test that indicates an individual’s immune 

status against anthrax. 

- Development of a vaccine with lower incidences of side effects. 

- The DoD policy could be modified so only personnel deploying to highrisk areas are vaccinated. 

- In spite of these potentials for improvement, the anthrax vaccine is safe 

and effective. 

The anthrax vaccine debate is probably best understood as an issue of 

trust, credibility, and confidence. 

- Lieutenant General (retired) James A. Scott writes in an editorial: 

 -- DoD’s credibility has been eroded by its handling of the Agent 

Orange and GWS issues. 

 -- Military personnel opposed to the anthrax vaccine have lost 

confidence in their leaders. 

 -- Military leaders must work to restore trust and confidence at all 

levels of the chain of command. 

 -- The anthrax vaccine debate should not be used as a test of 

leadership. 
- DoD should continue proactive educational efforts to inform all military 

personnel of the facts surrounding the anthrax vaccine, including 

cautions on how to interpret material presented on the internet. 
Contents 

Page 

Disclaimer.....................................................................................................i

The Author.................................................................................................. ii

Acknowledgments ..................................................................................... iii

I. Introduction.........................................................................................1 

II. Pathophysiology and Treatment of Human Anthrax Infections.........3 

III. Anthrax Vaccine, Adsorbed (AVA) ...................................................9 

IV. History of Production .......................................................................13 

V. Efficacy.............................................................................................19 

VI. Side Effects and Safety.....................................................................23 

VII. The Threat of Anthrax as a Biological Weapon, and 

Policy Decisions ...............................................................................27 

VIII. Arguments Against Anthrax Vaccine, Adsorbed .............................31 

IX. Conclusions and Recommendations.................................................47 

Notes..........................................................................................................51 

i 

Disclaimer

The views expressed in this publication are those of the author and do 

not necessarily reflect the official policy or position of the U.S. 

Government, Department of Defense, or the USAF Counterproliferation 

Center.
ii 

The Author 

Colonel Richard A. Hersack, USAF, MC, CFS, is the Air Force 

Surgeon General Chair to Air University at Maxwell AFB, AL. He also 

serves as a faculty member to the Air War College in the Department of 

Future Conflicts and is an associate of the United States Air Force 

Counterproliferation Center. He earned his Bachelors degree in Chemistry 

from the Colorado College in 1979 and his Doctorate of Medicine from 

the St. Louis University School of Medicine in 1983. After completing his 

surgical internship, Colonel Hersack served for six years as squadron 

medical element flight surgeon assigned to F-16 operational squadrons at 

Torrejon AB, Spain and Shaw AFB, SC. He completed his residency in 

anesthesiology at Wilford Hall Medical Center in 1993, becoming board 

certified by the American Board of Anesthesiologists in 1994. He 

remained at Wilford Hall as a staff anesthesiologist serving in a variety of 

positions, including Assistant Chairman for Resident Education, 

Department Vice Chairman, and the Author B. Tarrow Chairman of 

Anesthesia. He departed Wilford Hall in 1999 to attend the Air War 

College, graduating from the in-residence program in 2000. He is also a 

graduate of the Squadron Officers School, Air Command and Staff 

College, and Air War College non-residence programs. Colonel Hersack 

helped develop the Critical Care Air Transport Teams and the Mobile 

Field Surgical Teams and has participated in several operational 

deployments to Europe, Africa, and Central America, including Operation 

JOINT ENDEAVOUR, Operation ASSURED RESPONSE, and 

humanitarian medical missions to Honduras. His awards and honors 

include the Malcolm C. Grow Award as the United States Air Force Flight 

Surgeon of the Year for 1985, the United States Air Forces in Europe 

Command Flight Surgeon of the Year for 1985, the Society of Air Force 

Clinical Surgeons Surgeon General’s Award for Outstanding Research in 

Anesthesia, and Distinguished Graduate of the Anesthesia Residency 

Program at Wilford Hall. A chief flight surgeon, Colonel Hersack has 

logged over 700 total flying hours, including 337 hours in F-16 aircraft, 

and holds a private pilot’s certificate. 
iii 

Acknowledgments 

Attending the Air War College provided me an opportunity to step 

outside the clinical world of Air Force Medicine and learn about the rest 

of the Air Force, and its role in Joint and Coalition operations, from topnotch officers representing other specialty backgrounds, our sister 

Services, and our Allies. It also gave me the chance to consider the 

significant role Air Force Medicine is able to play in promoting our 

nation’s security through shaping the international environment to counter 

the numerous, and sometimes ambiguous, threats we will face in the 21st 

Century. I especially want to express my appreciation for the advice and 

encouragement I received while completing this work from Dr. Barry 

Schneider, the Director of the U.S. Air Force Counterproliferation Center, 

and from Col Jim Davis. I also would like to extend a special thank you to 

my wife Sharon for her patience, encouragement, and her extraordinary 

proofreading skills, without whom this endeavor would never have been 

possible. To her and my two sons, Jon and Steve, I dedicate this work, 

hoping that it may play at least a small role in protecting the health of our 

nation’s treasured military men and women from those who would wish us 

harm.
iv 
The Anthrax Vaccine Debate . . . 1 

The Anthrax Vaccine Debate: 

A Medical Review for Commanders 

Richard A. Hersack, Col, USAF, MC, CFS 

I. Introduction

On 6 February 2000, 60 Minutes aired an interview of an active duty

Air Force major who had refused to receive the vaccine for anthrax.1

 

Viewers learned that he faced the potential of a court-martial for refusing 

to obey orders.2

 The major’s refusal is just one aspect of a complex

controversy surrounding the Department of Defense’s Anthrax 

Vaccination Immunization Program.3

 Adding to the confusion are a 

myriad of press releases, communications and opinions from concerned 

individuals on the Internet, Congressional testimony, issues raised by 

those in the Reserve Components regarding any potential effects on their 

civilian careers, and numerous internet web sites both supporting and 

opposing vaccination. 

Needless to say, the anthrax vaccine debate is extremely complex. It 

is possible, however, to categorize the issues and concerns with the 

Anthrax Vaccine Immunization Program as either clinically related or 

administrative policy related, then address the two categories separately.4

 

An important aspect of the clinically related issues is to determine if the 

anthrax vaccine, Anthrax Vaccine, Adsorbed (AVA), is safe and provides 

effective protection against the effects of exposure to anthrax spores. 

What is needed is a clinical assessment based on data in the published, 

peer-reviewed medical literature and medical textbooks.5

 In addition, it is 

necessary to assess if credible alternatives to vaccination using Anthrax 

Vaccine, Adsorbed exist.

If medical personnel determine the vaccine is clinically safe and 

effective, as documented in the medical literature, then administrative 

policy-makers may determine if the vaccine should be administered to 

Department of Defense personnel. The decision to vaccinate Defense

Department personnel is a policy decision made by those in the legal chain 

of command and is based on intelligence estimates and relative risk

assessments related to the potential use of anthrax spores in a biological 
2 . . . The Anthrax Vaccine Debate 

weapon. Clinicians and Service medical corps officers do not set policy. 

Nor do they have the authority to order vaccination of all personnel. 

The intent of this paper is to provide military commanders and 

supervisors with pertinent clinical facts and information about anthrax and 

Anthrax Vaccine, Adsorbed in a single source document, written in lay 

terms, to serve as a working reference for use to educate those within their 

chain of command. Due to time and space limitations, this paper is not 

intended to be an exhaustive review.6

 Reviews and discussions of the 

evidence related to the risk of the use of anthrax as a biological weapon

and the policy decision to vaccinate Defense Department personnel are 

beyond the scope of this paper, which focuses instead on clinical issues 

related to the vaccine.

7

The paper will present a brief review of anthrax, including a 

description of the causative organism and how it causes disease in

humans, along with a review of the history of the vaccine and its 

manufacturer. Next, the paper will provide an overview of the medical 

literature to address safety, efficacy, side effects, and complications from 

vaccination, followed by the major points of controversy found in the 

media, on information world-wide-web sites, and in Congressional 

testimony. Then, the paper will attempt to bring the controversy into 

perspective, examining several of the arguments of those opposed to 

vaccination against anthrax, followed by presenting some conclusions and 

recommendations. The research methods employed for this paper include

a review of the peer-reviewed medical literature, medical textbooks, press

releases, and internet world-wide-web sites presenting information and 

opinions both for and against vaccination.8
The Anthrax Vaccine Debate . . . 3 

II. Pathophysiology and Treatment of Human Anthrax Infections 

The organism, Bacillus anthracis, is a Gram positive (meaning “rodshaped”) bacterium that exists in the soil in dormant spores and can be

found throughout the world.9

 The spores are able to exist in the soil for 

years under the right conditions, such as cool, dry climates, with adequate 

protection from sunlight.10 Grazing animals consume the spores that

germinate into bacteria inside the animal. The bacteria multiply inside the 

animal, causing disease, eventually leading to death. After death, the 

animal’s body decomposes, exposing the anthrax bacteria to the air. 

Oxygen in the air stimulates the bacteria to generate new spores that are 

released into the environment, either being deposited into the soil or

spread by carrion birds and biting insects.11

The word “anthrax” comes from the Greek word anthrakis, meaning 

“coal,” and refers to the coal-black skin lesions caused when anthrax 

bacilli infect the skin.12 Human anthrax has been recognized throughout 

recorded history. The fifth plague against Egypt recorded in the Book of 

Exodus in the Bible, and the Torah may have been an outbreak of 

anthrax.13 Ancient Greeks, Romans, and Hindus also describe diseases

associated with anthrax infection of humans.14

In more recent times, certain groups of people such as veterinarians 

and workers in the goat-hair or wool industries have been identified as 

having a higher risk of contracting anthrax. During the 1800s, anthrax 

was a significant agricultural and industrial problem.

15 Indeed, another 

name for inhalation anthrax is “woolsorters’ disease.”16 Exposure to 

anthrax spores in the work place is effectively controlled through animal

vaccination programs, good animal husbandry, vaccinating workers at risk 

for exposure, and improving working conditions. Such efforts have 

virtually eliminated anthrax as an occupational hazard in the United 

Kingdom since 1940.17 In the United States, human anthrax is extremely 

rare, with only 224 cases reported over 50 years.18

The most recent natural outbreak of human anthrax occurred in 

Zimbabwe in 1978 and lasted several years. Over 9,700 people became

infected and died. Notably, the outbreak was associated with a regional 

war during which time social services such as animal vaccination

programs and medical care broke down, demonstrating the importance of 
4 . . . The Anthrax Vaccine Debate 

preventive measures programs to control human and animal infection.19 

There has never been a case of human-to-human transmission of anthrax 

reported, leading most to conclude anthrax is not contagious.20

In humans, the anthrax bacillus causes three types of infections: 

cutaneous, inhalation, and gastrointestinal. Ninety-five percent of human 

anthrax infections are cutaneous. Spores enter through a break in the skin 

and germinate to form anthrax bacilli, leading to a localized infection. A 

vesicle then forms and ruptures to produce the characteristic coal-black 

lesion. Cutaneous anthrax is easily treated with antibiotics and the lesions 

heal without scarring. Most patients survive and develop immunity 

against anthrax.21 If left untreated, the mortality rate is between 10 and 20 

percent.22

Inhalation anthrax occurs in five percent of human anthrax infections 

and is caused when spores enter through the lungs, lodging in the alveoli, 

the microscopic air sacs where oxygen exchange with the blood occurs. 

The anthrax spores may reside in the lung alveoli for several weeks before 

germinating.23 Macrophages, cells designed to consume foreign bacteria 

as part of the body’s immune system, engulf the spores and then migrate 

from the lungs to lymph nodes in the chest. Inside the macrophages, the 

spores germinate, growing into mature anthrax bacilli. The bacilli 

multiply and eventually erupt from the macrophages, spreading 

throughout the blood stream. 

Initial symptoms of inhalation anthrax signal germination of the

spores into mature bacilli and are similar to any common upper respiratory 

tract infection. Since the symptoms are so non-specific, diagnosis at this 

point is not possible unless there is reason clinically to suspect anthrax

exposure. After a few days, the symptoms subside for a brief period of 12 

to 24 hours. This latent period is followed by an explosive period of 

severe symptoms, shock, and cardiovascular collapse, leading rapidly to 

death. During this final phase, massive numbers of anthrax bacilli 

circulate in the blood throughout the body, releasing deadly toxins. 

Once initial symptoms develop, nearly 100 percent of all cases of

inhalation anthrax are fatal (usually within three days) even with 

aggressive treatment using antibiotics and supportive intensive medical 

care. Therefore, if a potential exposure to inhalation anthrax is suspected, 

treatment must be initiated immediately before any symptoms occur. 
The Anthrax Vaccine Debate . . . 5 

Treatment should be continued either until the possibility of anthrax 

exposure is excluded or no more dormant spores are left in the lungs 

(usually 60 days).24

To develop inhalation anthrax, the subject must inhale a minimum 

number of spores. The number of spores required to kill at least 50

percent of subjects has been reported to be 8,000 to 10,000 but may range 

from as few as 2,500 to 5,500.25 Occupational studies of unvaccinated 

goat-hair and wool workers demonstrated they inhaled over 500 anthrax 

spores each day, but they did not develop inhalation anthrax.26 There have 

been no cases of inhalation anthrax reported in the United States since

1978 and only 18 cases in the last 80 years.27

Without deliberate aerosolization (such as during attack with a 

biological weapon), it is extremely rare for there to be a sufficient 

concentration of spores in the inhaled air to cause disease, even if there are 

large amounts of spores deposited on surfaces or in the soil. Studies

indicate that secondary aerosolization typically will not stir up enough 

spores from contaminated soil or surfaces to achieve sufficient 

concentrations in inhaled air to cause disease. Therefore, decontamination 

of large areas and soil is usually not indicated and the presence of residual 

anthrax spores may not necessarily hinder military operations as some

imply.28

Gastrointestinal anthrax results from consuming animal products or 

meat contaminated with anthrax spores. The initial infection occurs either 

in the mouth and throat or in the intestines. As in inhalation anthrax, 

macrophages engulf the spores that germinate, forming bacteria that enter 

the blood stream. The bacteria multiply and release toxins, leading to 

death in 50 percent of cases. Gastrointestinal anthrax is the rarest form of

anthrax infection and has not been reported in the United States.29

Rarely, anthrax may also infect the central nervous system, causing 

hemorrhagic meningitis.30 This form of anthrax infection does not 

represent a separate way for anthrax to infect humans. It is actually a 

complication of cutaneous anthrax, caused by anthrax bacilli spreading 

through the blood or lymphatic systems to infect the brain and spinal 

cord.31 This complication is not frequently seen with inhalation or 

gastrointestinal anthrax, probably because patients die before meningeal 
6 . . . The Anthrax Vaccine Debate 

infection by anthrax bacilli occurs. Meningeal anthrax is almost always 

fatal. 

Regardless of the route of infection, death is due to a massive toxic 

effect from large amounts of toxins produced by overwhelming numbers 

of anthrax bacilli circulating in the blood. The anthrax bacillus produces 

three toxins, called protective antigen, edema factor, and lethal factor.

The protective antigen binds to the patient’s cells, then to either of the 

other two toxins, forming complexes which penetrate the patient’s cells to 

cause massive cell swelling and rapid cardiovascular collapse.

32 All three

toxins work together for anthrax to cause disease. Without the protective

antigen, the other two toxins cannot penetrate the cells. 

Each anthrax bacillus also forms a protective protein capsule that 

surrounds the bacillus as it circulates in the blood. The capsule prevents 

the patient’s immune cells from consuming the anthrax bacilli. The 

anthrax bacillus must be able to produce all three toxins and the protective 

capsule in order to cause disease in humans.33 Weakened strains

(attenuated) of anthrax bacilli are unable to cause disease in humans 

because they lack the capability to produce either one or more of the 

toxins (usually the protective antigen), the protective capsule, or both.

These attenuated (weakened) strains are used to produce anthrax vaccines.

The human body normally fights infection two ways: by producing 

antibodies that circulate in the blood which recognize and attach to foreign 

proteins, called antigens, and by special cells (such as macrophages) that 

engulf (called phagocytosis) the bacteria to kill and digest them. Usually 

these two processes work together. Antibodies bind to antigens on 

invading bacteria to mark the bacteria. This attracts macrophages to the 

bacteria so the macrophages may phagocytize them. Antibodies also bind 

to circulating antigens, produced and released by bacteria into the blood

stream, to neutralize their effect. 

Anthrax bacilli that are able to cause disease inhibit both parts of the 

immune process. After coupling with protective antigen, the toxins, 

edema factor and lethal factor, penetrate into the patient’s cells where 

antibodies in the blood cannot get to them to neutralize their toxic effect. 

The protective capsule formed by anthrax bacilli in the blood inhibits 

phagocytosis. As a result, the body’s defenses are rendered ineffective. 
The Anthrax Vaccine Debate . . . 7 

Understanding these basic concepts is important in order to understand the 

strategy of treatment regimens and vaccination programs. 

The antibiotic of choice for treating anthrax infections is penicillin.34 

For individuals who have an allergy to penicillin, doxycycline is the 

approved alternative. There are, however, antibiotic resistant strains of

anthrax for which neither of these drugs are effective. Ciprofloxacin has 

been demonstrated in animal studies to be extremely effective against 

penicillin-resistant anthrax and is recommended by consensus panels as 

the antibiotic of choice for treating casualties potentially exposed to 

anthrax spores during an attack.35 The Food and Drug Administration 

recently approved ciprofloxacin to treat anthrax in humans.36

The treatment strategy for personnel exposed to aerosolized anthrax 

spores consists of a combination of antibiotics and vaccination. 

Antibiotics are not effective against toxins and will not prevent the rapid

deterioration and death of the patient caused by the toxins. Personnel 

potentially exposed should receive a vaccination that will stimulate their 

immune systems to produce antibodies against the toxins (specifically 

protective antigen) produced by anthrax bacilli, protecting them against

the toxins’ deadly effects and conferring immunity. But, vaccinating 

exposed personnel will not kill the anthrax bacilli. Treatment with 

antibiotics is required to kill the bacilli. This combined therapy of 

antibiotics and vaccination for inhalation anthrax must begin as soon as 

exposure to aerosolized anthrax spores is suspected and before any 

symptoms develop. Once symptoms develop, anthrax spores have already 

germinated into bacteria that are producing toxins, and death will most 

likely occur in spite of treatment.37
8 . . . The Anthrax Vaccine Debate 
The Anthrax Vaccine Debate . . . 9 

III. Anthrax Vaccine, Adsorbed (AVA)

Anthrax Vaccine, Adsorbed is the Food and Drug Administration’s 

approved and licensed vaccine for use to immunize humans against 

anthrax infection. The strain of anthrax bacteria used to make Anthrax 

Vaccine, Adsorbed lacks the ability to make the protective capsule (cannot 

prevent the body’s defensive macrophages from phagocytizing the

bacteria) and is unable to produce disease in humans. There are no live 

bacteria and no intact cells in the vaccine, so it is impossible to get 

infected with anthrax from the vaccine. The vaccine consists of protective 

antigen isolated from these attenuated (unable to produce disease) anthrax 

bacteria.38 Protective antigen has been shown to be the essential antigen

for provoking the immune response against anthrax in both animals and 

humans. Every anthrax vaccine developed that has been demonstrated as 

effective in immunizing test subjects against anthrax involves the use of 

protective antigen as the primary agent to trigger the immune response.39 

After injection, the vaccine stimulates the individual’s immune system to 

produce antibodies against protective antigen, which protect the individual 

from future infections by anthrax bacilli. After vaccination, it takes the 

individual some time to develop enough immunity to confer protection 

and one dose may or may not be fully protective.40 Therefore, a nonimmunized person exposed to aerosolized anthrax spores, in addition to 

immediate vaccination with the anthrax vaccine, requires treatment with 

antibiotics to prevent disease. 

The current dosage schedule approved by the Food and Drug 

Administration (FDA) for Anthrax Vaccine, Adsorbed is three injections 2

weeks apart followed by three more injections 6 months apart. After the 

completed course, an annual booster is required to maintain immunity. 

Animal and human studies suggest that Anthrax Vaccine, Adsorbed may 

confer immunity with fewer doses. But, since the vaccine is currently licensed

with the six-dose regimen, this regimen should be followed until clinical 

studies confirm adequate protection could be achieved with fewer doses. 

Formaldehyde (up to 0.02 percent) is used as a stabilizer in Anthrax 

Vaccine, Adsorbed and benzethonium chloride (0.0025 percent) as a 

preservative.

41 The Food and Drug Administration has approved the use 
10 . . . The Anthrax Vaccine Debate 

of formaldehyde in trace amounts as a preservative.42 The use of 

formaldehyde as a preservative is actually quite common and has been 

done for the past 40 years. For example, tetanus toxoid, given to all 

school children in the United States, contains trace amounts of 

formaldehyde, yet it has been used safely for decades to induce immunity

in millions of people by stimulating the production of antibodies against 

tetanus.43

Anthrax Vaccine, Adsorbed does not contain, nor has it ever 

contained, squalene as an additive. Squalene is a substance sometimes 

used to increase the potency of certain vaccines.44 Squalene occurs 

naturally in humans and is a precursor in the synthesis of cholesterol.45 

Squalene is also found in large amounts in deep-sea shark liver. There are 

currently several health food supplemental products on the market 

containing squalene. Proponents claim squalene improves the delivery of 

oxygen to cells and facilitates the clearance of metabolic toxins.46

Recent reports have stated that newly developed tests have detected

trace amounts of squalene in Anthrax Vaccine, Adsorbed and other 

commonly used vaccines.47 Previous tests were only able to detect the

presence of squalene in parts per million, but the newer, more sensitive 

tests are able to measure the presence of squalene down to the parts per 

billion. The concentration of squalene detected in the anthrax vaccine, 

diphtheria vaccine, and tetanus toxoid, using the newer tests, is about ten 

parts per billion. The normal concentration of squalene circulating in 

human blood is many times higher, about 250 parts per billion, suggesting 

the presence of trace amounts of squalene in the anthrax vaccine is not 

clinically significant. The presence of trace amounts of squalene in the 

anthrax vaccine and in the other vaccines may be a normal bi-product of

the production process.48

There have been articles in the press attempting to draw a 

connection between the use of Anthrax Vaccine, Adsorbed and Gulf 

War Syndrome, claiming the agent causing Gulf War Syndrome is 

squalene. These press reports claim veterans suffering from Gulf War 

Syndrome have antibodies to squalene in their blood that they got from 

Anthrax Vaccine, Adsorbed.49 Others have gone so far as to charge the 

Defense Department may have secretly added squalene to lots of the

vaccine used for inoculation of troops to increase its efficacy. They 
The Anthrax Vaccine Debate . . . 11 

claim, without presenting any evidence, that Anthrax Vaccine, 

Adsorbed vial labels may have been altered and that lack of

documentation in personal shot records suggests a cover-up.50
12 . . . The Anthrax Vaccine Debate 
The Anthrax Vaccine Debate . . . 13 

IV. History of Production 

Merck, Sharp & Dohme developed the first anthrax vaccine for use in 

humans during the 1950s to protect workers routinely exposed to anthrax 

spores.51 Clinical trials performed in the late 1950s and published in 1962 

demonstrated that the vaccine was effective in preventing cutaneous 

anthrax.52 Later, the Department of Defense approached the state of

Michigan to manufacture anthrax vaccine for Defense Department 

personnel. The Defense Department chose the state of Michigan because

there was little profit potential to motivate private industry to manufacture 

a vaccine that would not be used in the general public, and Michigan had 

extensive experience manufacturing other vaccines such as rabies vaccine. 

The Michigan Biological Products Institute began to produce Anthrax 

Vaccine, Adsorbed for the Defense Department. Anthrax Vaccine, 

Adsorbed is essentially the same vaccine as initially produced by Merck, 

Sharp & Dohme except that Anthrax Vaccine, Adsorbed is more potent 

and more pure, due to some minor differences in production technique.53 

In 1970, the National Institute of Health’s Division of Biologics Standards

licensed Anthrax Vaccine, Adsorbed, then transferred the license, along 

with oversight and regulatory authority, to the Food and Drug 

Administration in 1972.54 Licensing was based on data collected during 

studies using the older anthrax vaccine and Anthrax Vaccine, Adsorbed to 

protect workers at risk for infection. The study using the older, less potent 

vaccine (published in 1962) measured the older vaccine’s effectiveness to

protect wool mill workers at risk for both cutaneous and inhalation

anthrax. The Centers for Disease Control and Prevention collected data 

over a 10-year period, after 1960, using Anthrax Vaccine, Adsorbed to 

measure how effectively it prevented cutaneous anthrax in workers at risk 

for infection. Of note, the licensing procedures also cited the 

demonstrated low risk of serious side effects.55

As tensions in the Persian Gulf mounted in early 1990, the Defense 

Department asked Michigan Biological Products Institute to dramatically 

increase the production rate of Anthrax Vaccine, Adsorbed.56 Michigan

Biological Products Institute informed the Defense Department it would 

not be able to meet production expectations with the facilities it possessed 

at that time. Michigan Biological Products Institute then worked out a 
14 . . . The Anthrax Vaccine Debate 

plan with the Defense Department to upgrade their production facilities 

with Defense Department funding and presented the plan to the Food and 

Drug Administration in 1995. The Food and Drug Administration 

approved the facility upgrade plans. 

Between 1995 and 1997, the Food and Drug Administration 

performed several inspections of Michigan Biological Products Institute’s 

facilities used to produced rabies vaccine and plasma derivative products. 

During these inspections, the Food and Drug Administration found 

numerous discrepancies with policies and procedures, record keeping,

analytical laboratories, quality control practices, raw materials handling,

filling and packaging, and storage, warehousing, and distribution.57 It

must be noted that none of these production facilities, nor any of the Food 

and Drug Administration’s findings, involved the production, safety, or 

quality of Anthrax Vaccine, Adsorbed. In March 1997, the Food and 

Drug Administration sent Michigan Biological Products Institute a letter 

indicating the they would begin procedures to revoke Michigan Biological 

Products Institute’s license due to lack of adequate progress to address the 

discrepancies noted during the inspections of the facilities used to produce 

rabies vaccine and plasma derivative products. 

In the meantime, Michigan Biological Products Institute had applied 

to the Food and Drug Administration to upgrade its Anthrax Vaccine, 

Adsorbed production facilities to meet the increased demand for vaccine

resulting from the Defense Department’s Anthrax Vaccine Immunization 

Program. The Food and Drug Administration approved the planned 

upgrade and, in January 1998, Michigan Biological Products Institute 

voluntarily stopped production of Anthrax Vaccine, Adsorbed in order to 

begin the Food and Drug Administration-approved renovations to the 

production facilities. It is important to note that the stoppage of 

production of the Anthrax Vaccine, Adsorbed is completely unrelated to 

the discrepancies noted during the Food and Drug Administration 

inspections of rabies vaccine and plasma derivative products production

facilities and is completely unrelated to their letter of intent to revoke 

Michigan Biological Products Institute’s license.

In 1997, Secretary of Defense Cohen made the decision to implement

the Anthrax Vaccine Immunization Program (AVIP) to vaccinate all 

military personnel using lots of Anthrax Vaccine, Adsorbed already on 
The Anthrax Vaccine Debate . . . 15 

hand. Since supplies of the vaccine were limited, the immunization

program was divided into three phases. Completion depended on the 

production and release to the Department of Defense of additional lots of 

vaccine after the production facilities were upgraded. Only the first phase 

has been implemented, meaning only personnel at risk for exposure to 

inhalation anthrax in high risk areas (i.e., Korea and the Persian Gulf) will 

be vaccinated. 

Part of the Secretary’s directive was that each lot of vaccine would be 

completely re-tested (referred to as “supplemental testing”) using Food 

and Drug Administration testing procedures to reconfirm potency, safety, 

purity, and sterility. Each lot had to pass supplemental testing before it 

would be administered to Defense Department personnel. The lots

undergoing supplemental testing had already passed Food and Drug 

Administration certification, been released by them for sale, and 

purchased by the Defense Department. 

Eight lots have undergone this supplemental testing for potency and 

were released before a problem with the potency test itself was discovered

in the Fall of 1998.58 Since then, the potency testing difficulties have been 

corrected and the test is now working according to specifications.59 But,

the Food and Drug Administration will not release any additional lots until 

it is satisfied with the quality of the vaccine and has approved necessary

potency test amendments implemented to correct the earlier potency

testing problems.

60

In September 1998, the state of Michigan sold the Michigan 

Biological Products Institute facilities with the licensing rights to BioPort 

as part of an effort to privatize government programs and cut costs.61 In

late 1999, BioPort completed the renovations and applied to the Food and 

Drug Administration for inspection and certification of the new production 

facilities.62 But BioPort continues to have problems with its renovated 

facility and still has not received Food and Drug Administration 

certification.63

In the meantime, BioPort has started producing new lots of anthrax 

vaccine.64 It is important to note that the new lots produced by BioPort 

have not been certified or released for sale by the Food and Drug 

Administration, have not been purchased by the Defense Department, and 

have not been administered to anyone. Furthermore, the Defense 
16 . . . The Anthrax Vaccine Debate 

Department will not purchase these lots to begin Phase Two of the 

Anthrax Vaccine Immunization Program until the BioPort facility passes

Food and Drug Administration inspection and they have tested, certified, 

and released the new lots for distribution.65

BioPort has a total of 32 lots of Anthrax Vaccine, Adsorbed in storage 

for the Defense Department, produced by the Michigan Biological 

Products Institute division before the production facilities were shut down 

for renovations. In February 1998, the Food and Drug Administration 

inspected these lots of vaccine and Michigan Biological Products Institute 

voluntarily quarantined 10 lots mentioned in the Food and Drug 

Administration report. The Defense Department has not used these lots 

for the immunization program. These lots will remain quarantined until 

testing confirms adequate sterility, potency, and quality to the Food and 

Drug Administration’s satisfaction.66 In addition, one other lot was

permanently quarantined due to questions regarding sterility and will not 

be used. Furthermore, 14 lots were tested at random and found not to 

contain any squalene.67

Most recently, the rate of vaccination of Defense Department 

personnel under the Anthrax Vaccine Immunization Program has been 

reduced due to the dwindling supply of vaccine. As of May 2000, 17 lots 

of vaccine have passed Food and Drug Administration certification tests 

and passed re-certification tests as ordered by the Secretary of Defense.68 

Defense Department officials have pointed out on numerous occasions in

the media and in sworn testimony that only these 17 lots have been used 

for the immunization program. 

Defense Department officials had hoped that BioPort would have 

obtained Food and Drug Administration approval and new lots tested and 

released by the Food and Drug Administration by now.69 Due to ongoing 

problems with BioPort obtaining certification (the Food and Drug 

Administration has identified 30 deficiencies that need to be rectified

before it grants certification), no new lots are available for the

immunization program, forcing the slowdown in the program. In addition,

some members of Congress who are dissatisfied with BioPort’s situation 

are beginning to urge the Defense Department to consider designing a

Government Owned, Contractor Operated (GOCO) vaccine production 

facility.70
The Anthrax Vaccine Debate . . . 17 

In summary, it should be noted that Anthrax Vaccine, Adsorbed is a 

Food and Drug Administration licensed, non-experimental vaccine. 

Anthrax Vaccine, Adsorbed is more potent and purer than, but otherwise

identical to, the earlier version of the vaccine produced in the 1950s by 

Merck, Sharp & Dohme. Michigan Biological Products Institute 

voluntarily stopped production of Anthrax Vaccine, Adsorbed in order to 

upgrade the vaccine production facilities, not due to the results of any 

Food and Drug Administration inspections. Michigan Biological Products 

Institute then sold its Anthrax Vaccine, Adsorbed production facilities to 

BioPort. 

The lots currently in use for the Anthrax Vaccine Immunization

Program were produced before the renovations began, tested and certified 

by the Food and Drug Administration for release and distribution, and retested by the Defense Department before administration. No lots produced 

by BioPort since it purchased and renovated the Michigan Biological 

Products Institute production facilities have been used by the Defense 

Department to vaccinate its personnel. The Defense Departmentmandated supplemental testing, BioPort’s voluntary quarantine of lots 

previously released by the Food and Drug Administration, and the 

modifications implemented to improve the quality of testing for potency 

demonstrate the intense level of interagency scrutiny that exists to ensure 

the Defense Department’s Anthrax Vaccine Immunization Program attains

the highest possible levels of safety for its personnel. 
18 . . . The Anthrax Vaccine Debate 
The Anthrax Vaccine Debate . . . 19 

V. Efficacy

A controlled study using the original anthrax vaccine produced by

Merck, Sharp & Dohme and supplied by the U.S. Army Chemical Corps 

was published by Brachman, et al., in 1962.71 The study looked at how

effectively the vaccine prevented anthrax in a population of wool mill 

workers considered to be at risk for contracting anthrax. Historically, 

about one percent of these workers contracted cutaneous anthrax annually. 

To do the study, volunteers were divided into two groups–one group 

received the vaccine and the other received a placebo (an inactive 

substance used as a control that looks like the vaccine, but is harmless and 

has no biological effect). The vaccination schedule used in the study 

matches the current Food and Drug Administration approved schedule for 

vaccinations using Anthrax Vaccine, Adsorbed. The rate of occurrence of 

anthrax in the vaccinated group was compared to the rate of occurrence in 

the group that received the placebo and all other workers not participating

in the study. 

During the study period there were 26 cases of anthrax. One case of 

cutaneous anthrax appeared in a fully vaccinated individual. Twenty-three

cases of anthrax appeared in unvaccinated workers and two in partially

vaccinated (meaning they did not complete the series of immunizations)

workers. No cases of inhalation anthrax occurred in vaccinated or 

partially vaccinated workers, although five cases of inhalation anthrax 

occurred in unvaccinated workers during the study period. Four of these 

cases were fatal. The frequency of occurrence of inhalation anthrax was 

not sufficient to determine any statistical significance for how effective the 

vaccine was in preventing inhalation anthrax.72

As already pointed out, the vaccine used in the Brachman study was 

also a protective antigen vaccine similar to Anthrax Vaccine, Adsorbed, 

but less potent and less pure (it contained more cell fragments). Since the 

mechanism to produce immunity is the same for both vaccines, 

Brachman’s study results are relevant when discussing the issue of 

efficacy of Anthrax Vaccine, Adsorbed. In addition, other surveillance

studies using Anthrax Vaccine, Adsorbed completed since the publication 

of Brachman’s study confirm the vaccine’s efficacy in preventing anthrax 

in humans.73
20 . . . The Anthrax Vaccine Debate 

Between 1962 and 1974, the Centers for Disease Control and 

Prevention (CDC) collected data measuring the occurrence of anthrax in 

workers at risk for infection who had been vaccinated with Anthrax 

Vaccine, Adsorbed versus non-immunized workers. The study also 

tracked any adverse reactions to the vaccine.

74 During this period, an 

additional 27 cases of cutaneous anthrax were identified, three in partially

immunized workers who had only received one or two doses. There were 

no cases of anthrax in the fully immunized workers.75 A total of 7,000 

workers received more than 16,000 doses of Anthrax Vaccine, 

Adsorbed.76 The efficacy data from the Brachman study, using the 

original protective antigen vaccine, and the Centers for Disease Control 

and Prevention study, using Anthrax Vaccine, Adsorbed, were eventually 

used during the licensing procedures for Anthrax Vaccine, Adsorbed.77

Between 1974 and 1989, it is estimated that an additional 68,000 

doses of Anthrax Vaccine, Adsorbed were administered to at risk 

individuals.78 There were no cases of cutaneous anthrax in vaccinated 

individuals although there continued to be reported cases of cutaneous 

anthrax in unvaccinated people at risk. In addition, the rate of adverse 

side effects remained low, comparable to rates cited in the Food and Drug 

Administration-required package insert that accompanies each vial of 

Anthrax Vaccine, Adsorbed.79 Due to the increasing rarity of anthrax

infections, the fact that workers at risk for exposure to anthrax spores are 

immunized, and improvements in working conditions, any additional field 

studies of anthrax vaccine are unlikely.80 In conclusion, the clinical data

collected over several decades indicate that Anthrax Vaccine, Adsorbed is 

very effective in preventing cutaneous anthrax and, potentially, inhalation 

anthrax in humans.81

Fortunately, inhalation anthrax in humans is very rare even among 

unvaccinated workers routinely exposed to anthrax spores. Improvements 

in the work place plus use of Anthrax Vaccine, Adsorbed in workers at 

risk for exposure to anthrax spores essentially eliminated the occurrence of 

inhalation anthrax.82 But, the rareness of this disease also means it is not 

possible to collect enough data in humans to determine if Anthrax 

Vaccine, Adsorbed would prevent inhalation anthrax in humans. In order 

to do a study in humans, one would have to take volunteers, divide them 

into two groups, vaccinate one group with Anthrax Vaccine, Adsorbed, 
The Anthrax Vaccine Debate . . . 21 

the other with a placebo. Then the experiment would have to expose both 

groups to lethal doses of aerosolized anthrax spores, and track how many 

in each group contract the disease. Obviously, any such study would be 

unethical, illegal, and should not take place. 

Numerous animal studies have been performed to measure the 

effectiveness of Anthrax Vaccine, Adsorbed to prevent inhalation anthrax. 

Granted, there is always a possibility that results in one species of animals

cannot be assumed to represent potential results in another species. For 

example, animal studies suggest that some species are more difficult to 

immunize against anthrax infections, using Anthrax Vaccine, Adsorbed, 

than others. In guinea pigs, Anthrax Vaccine, Adsorbed seems to confer 

variable protection against certain strains of anthrax, suggesting possible

species-dependent differences in the guinea pig’s immune system. Guinea 

pigs seem especially sensitive to one particular strain of anthrax, called the 

Ames strain, even after they are fully immunized with Anthrax Vaccine, 

Adsorbed. 

On the other hand, Anthrax Vaccine, Adsorbed confers excellent

protection in rabbits and non-human primates against the Ames strain, 

providing near 100 percent protection even after as few as two 

inoculations, including situations where they are exposed to several times 

the lethal dose of anthrax spores. Moreover, inhalation anthrax infections

in non-human primates closely resemble inhalation anthrax infections in 

humans.83 Based on the animal studies results and the absence of

cutaneous and inhalation anthrax in fully immunized individuals exposed 

to anthrax spores, it is reasonable to conclude that Anthrax Vaccine,

Adsorbed prevents inhalation anthrax in humans.

84
22 . . . The Anthrax Vaccine Debate 
The Anthrax Vaccine Debate . . . 23 

VI. Side Effects and Safety 

The side effects and adverse reactions recognized as caused by 

Anthrax Vaccine, Adsorbed tends to be grouped into four main categories: 

mild local reactions, moderate local reactions, severe local reactions, and 

systemic reactions. Mild local reactions are defined by tenderness and 

redness in an area less than 1 to 2 cm in diameter and occur about 30 

percent of the time. Moderate local reactions are identified by an area of

response greater than 5 cm in diameter and occur about 4 percent of the

time. Severe local reactions are characterized by extensive swelling

(edema) of the arm and forearm in which the vaccine was administered.

These occur less frequently than moderate reactions. In general, the rate

of local reactions is about twice as high in women than men.85 Systemic

reactions are characterized by fever, chills, nausea, and body aches and 

occurs in less than 0.2 percent of vaccinations.86 Allergic reactions are

even less common, being reported in only one per 100,000 doses.87

Normally it takes three doses of Anthrax Vaccine, Adsorbed before an 

individual begins to develop an immune response and seem to correlate 

with the observation that reactions to subsequent doses of Anthrax 

Vaccine, Adsorbed tend to be stronger.88 Individuals who have had 

cutaneous anthrax or who have severe local or systemic reactions to the 

vaccine are not to receive Anthrax Vaccine, Adsorbed.89 In a study

conducted from 1962 to 1974, the Centers for Disease Control and 

Prevention tracked the occurrence rates of reactions during the 

administration of more than 16,000 doses of Anthrax Vaccine, Adsorbed 

to over 7,000 individuals. The results of this study are the rates reported 

on the informational package insert accompanying each vial of Anthrax

Vaccine, Adsorbed as required by the Food and Drug Administration.90

Since Anthrax Vaccine, Adsorbed was licensed in 1970, there have

been numerous reviews documenting the occurrence of side effects 

attributable to Anthrax Vaccine, Adsorbed. An independent civilian

advisory panel met in 1985 to review the results of the 1962 to 1974 

Centers for Disease Control and Prevention study.91 The panel reported 

that only a few systemic side effects had occurred which all resolved.

Local reactions were typically mild and also resolved.92 From 1974 to 

1989, over 68,000 doses of vaccine were administered to persons 
24 . . . The Anthrax Vaccine Debate 

considered at risk for contracting anthrax (such as goat-hair workers, 

laboratory personnel, livestock handlers, and veterinarians). Yet, after 

more than 30 years of use, no long-term side effects have been reported in 

association with Anthrax Vaccine, Adsorbed.93

Since 1973, the U.S. Army Medical Research Institute of Infectious

Diseases (USAMRIID) at Fort Detrick, Maryland, has actively followed 

1,590 workers who have received more than 10,000 doses of Anthrax 

Vaccine, Adsorbed, again with no reported long-term or chronic side 

effects. Only 4 percent reported local reactions and only 0.5 percent had 

any type of systemic reactions. All reactions resolved without any lost 

work time.94 Another study conducted by the Canadian Armed Forces 

reported that in 547 individuals who received Anthrax Vaccine, Adsorbed, 

rates of reaction were less than the rates listed on the Anthrax Vaccine, 

Adsorbed package insert. There were no long-term effects except for one 

individual who reported a persistent nodule at the injection site.95

In addition to the Centers for Disease Control and Prevention study, 

the USAMRIID study, and the Canadian study, there are three other 

separate studies on Anthrax Vaccine, Adsorbed, examining the rate of 

occurrence of adverse reactions. In 1997, Pittman reported on 508 

subjects who were actively followed after they received Anthrax Vaccine,

Adsorbed. Local reaction rates were roughly the same as reported by 

other studies. But Pittman noted a much higher rate of systemic reactions. 

Twenty-nine percent were classified as mild and 14 percent were 

classified as moderate to severe. Another study, conducted at Tripler 

Army Medical Center in Hawaii, reported a rate of mild systemic effects 

of 43 percent and moderate to severe in 5 percent out of a total of 536 

individuals vaccinated. Both studies are significant in that they report 

moderate to severe systemic reactions much higher than the 0.05 percent 

to 0.2 percent usually reported. And they differentiate between mild and 

moderate to severe systemic reactions.

96

The third study is an ongoing Department of Defense study which 

reported in May of 1999 that out of 223,000 individuals vaccinated, 42

experienced adverse side effects which were reported to the Food and Drug 

Administration and the Centers for Disease Control and Prevention. Of these, 

seven either missed more than one day of work or required hospitalization. 

None of these studies note any long-term or chronic adverse effects 
The Anthrax Vaccine Debate . . . 25 

attributable to Anthrax Vaccine, Adsorbed and none question the safety of 

the vaccine in their conclusions.97 In addition, there have been no cases of 

anaphylactic reactions (severe, potentially life threatening, systemic allergic

reactions) reported due to Anthrax Vaccine, Adsorbed administration.98

There have been multiple review panels, including panels hosted by

the Food and Drug Administration, the Centers for Disease Control and 

Prevention, the World Health Organization, and the Armed Forces 

Epidemiological Board. Most recently, a civilian panel of 21 experts from 

several major medical and research centers led by Dr. Thomas V. Inglesby 

convened to assess the risk that anthrax could be used as a biological weapon 

agent. The panel also developed a consensus on the care and management of 

victims of an anthrax biological weapon attack and examined the safety and 

efficacy of Anthrax Vaccine, Adsorbed. The panel’s results were published in

May 1999 in the Journal of the American Medical Association.

99

The panel concluded that the likelihood that anthrax could be used in 

a terrorist attack is high. The panel also reported that its investigation of 

the clinical data on the use of Anthrax Vaccine, Adsorbed showed no

serious adverse effects have been causally related to the vaccine, and they 

reached a consensus for recommending treatment protocols to care for

anthrax victims. The panelists recommended that new research should be 

devoted to developing a next-generation anthrax vaccine that requires 

fewer doses to immunize humans. Their findings correlate with the 

findings of numerous other review panels examining the medical literature

published on Anthrax Vaccine, Adsorbed, which confirm the clinical 

safety and the efficacy of the vaccine in humans.100

In 1990, the Food and Drug Administration and Centers for Disease 

Control and Prevention launched the Vaccine Adverse Events Reporting 

System. This is a passive reporting system, meaning success depends on 

medical personnel, patients, and families taking the initiative to file reports.

As of 23 August 2000, 1,859,666 doses of Anthrax Vaccine, Adsorbed

have been administered to 463,027 personnel with 945 reports submitted 

to the Vaccine Adverse Events Reporting System. Of these reports, 492 

were determined to be actually due to Anthrax Vaccine, Adsorbed – 374

were less than serious, 111 reported a loss of more than 24 hours of duty, 

and 7 were hospitalized for allergic inflammatory reactions at the injection

site. All symptoms resolved and there were no permanent side effects.101
26 . . . The Anthrax Vaccine Debate 

In addition to the Food and Drug Administration reviews of the

Vaccine Adverse Events Reporting System data, the Defense Department

convened the Anthrax Vaccine Executive Committee composed of nongovernment medical experts. This committee meets periodically to review 

the Vaccine Adverse Events Reporting System reports.102 Since its first 

meeting in 1990, the committee has not identified any unexpected patterns 

of adverse events among the reports submitted to the Vaccine Adverse 

Events Reporting System.103 The committee continues to meet every six

weeks to review data reported on the vaccine.104

To date, the Anthrax Vaccine Executive Committee has concluded it 

is not possible to attribute to Anthrax Vaccine, Adsorbed all the symptoms 

reported to the Vaccine Adverse Events Reporting System. But, for the 

sake of argument, if one assumes that all the reports could be linked 

causally to the vaccine, the rate of adverse reactions, including serious or 

severe ones, is still less than 0.03 percent. This is below the rate of 0.05

percent reported by other studies and well below the rate of 0.2 percent 

listed in the Anthrax Vaccine, Adsorbed product information package 

insert. By way of comparison, the hepatitis B vaccine, required for all

health care workers, has a systemic reaction rate five times greater than 

that observed due to Anthrax Vaccine, Adsorbed.105 Based on the Vaccine

Adverse Events Reporting System data, the Food and Drug Administration 

has concluded that it has no concerns about the safety of Anthrax Vaccine, 

Adsorbed and “continues to view the anthrax vaccine as safe and effective 

for individuals at risk of exposure to anthrax.”106

In all there have been at least 13 studies conducted in humans

assessing the safety of Anthrax Vaccine, Adsorbed or its precursor 

protective antigen vaccine, including those discussed in this paper, 

covering almost 50 years of clinical experience.107 The clinical evidence 

accumulated is consistent from study to study and demonstrates that 

Anthrax Vaccine, Adsorbed is safe and effective. This vaccine quite 

possibly has undergone more scrutiny than any other vaccine developed 

for human use, yet it continues to find endorsement in medical textbooks, 

in the medical peer-reviewed literature, and in sworn testimony given 

before Congressional panels as a safe and reliable vaccine against human 

anthrax infections.108
The Anthrax Vaccine Debate . . . 27 

VII. The Threat of Anthrax as a Biological Weapon, and Policy 

Decisions 

As stated in the introduction, the main purpose of this paper is to 

provide an overview of the use of Anthrax Vaccine, Adsorbed from a 

clinical perspective to determine if the vaccine is clinically safe and 

effective. The decision to vaccinate all Defense Department personnel 

against anthrax is a policy decision that is based on available intelligence

estimates that an attack against U.S. personnel may occur using anthrax as 

a biological agent. A review of all the evidence used to make that 

decision is beyond the scope of this paper. Suffice it to say, there is a 

clear consensus in the literature and the media among senior Defense

Department officials and policy-makers that the threat posed by the 

potential use of anthrax against U.S. military personnel is real and

significant.109

Several reports and testimonies document how easy it is to acquire, 

grow, and weaponize anthrax spores.110 Evidence confirms the existence

of active biological programs in the former Soviet Union, Iraq, and at least 

five other nations involving ongoing efforts to develop and stockpile 

anthrax weapons.111 In addition, various U.S. agencies receive terrorist

threats against U.S. interests each day.

112 In light of this evidence, many 

feel the U.S. is under-prepared to deter or respond to a biological attack.113 

But even though the U.S. may be under-prepared, many are opposed to the 

use of Anthrax Vaccine, Adsorbed to protect U.S. military personnel from 

the biological agent most likely to be used in an attack. Recently, a bill 

has been introduced in Congress calling for suspension of the Defense 

Department Anthrax Vaccine Immunization Program.

114

Many believe that the most likely place U.S. troops would face attack

from an anthrax weapon is on the battlefield in an open conflict where the 

mortality rate could be as high as 80 percent.115 One pilot refusing to take

Anthrax Vaccine, Adsorbed stated in an interview that if a war occurs, he 

will submit to vaccination against anthrax.116 But, other staff studies 

conclude the least likely use of anthrax as a weapon would be overtly on 

the battlefield during a war.117 These argue that it is much more likely that

a terrorist group or covert operator would use an anthrax-based biological 

weapon as a weapon of stealth.118
28 . . . The Anthrax Vaccine Debate 

Currently, the U.S. does not possess the capability to detect and warn

of a small-scale biological attack at the time it occurs. Current detection 

systems do not provide comprehensive real-time detection and warning. 

Furthermore, if the agent is not released upwind of a detection unit, the 

unit may not detect the agent at all. Indeed, the first indication that an 

attack using anthrax has occurred may be the outbreak of symptoms.

119 

Protective masks issued by the military do provide passive protection. 

But, to be effective, protective masks must be worn at the time of attack. 

Since detection and early warning are not possible, protective masks 

would have to be worn at all times to provide effective protection from 

anthrax, and because it takes time for an individual to develop an immune 

response after inoculation with Anthrax Vaccine, Adsorbed, immunization 

at the time an attack using anthrax as a weapon is believed to be imminent

will not provide any protection.120 Therefore, the best, and most practical,

real-time protection currently available against an anthrax weapon attack 

is prior vaccination. 

Vaccination of all military personnel against anthrax could provide a

powerful deterrent against any attack by an adversary using biological 

agents. As already pointed out, anthrax is the cheapest and most easily 

weaponized agent of all potential biological agents. It is also potentially 

the most effective, making it the most likely biological agent an adversary

would select to attack our forces. If our forces are protected against

anthrax, a potential adversary probably will not have an alternative

biological agent to employ as a weapon. Furthermore, fully immunizing 

our military personnel should deter any attack using anthrax since the 

effects of such an attack would likely be small and not worth the risk and 

costs of triggering a retaliation against the attacker by the United States. 

No vaccine is totally risk-free and complications from vaccination

will occur. All vaccines have potential adverse reactions that could be 

severe. Vaccination programs should only be undertaken when the risk of 

contracting a disease, with its associated complications, outweigh the risks

associated with vaccination. In other words, the decision to vaccinate 

should be based on risks versus benefits analysis, weighing the potential

risk that biological attacks with anthrax weapons could occur against the 

potential risks of reactions to the vaccine. The risk that an anthrax weapon

could be used to attack U.S. military personnel is significant, and the 
The Anthrax Vaccine Debate . . . 29 

disease caused by the weapon, inhalation anthrax, is highly lethal. By 

contrast, the clinical evidence we have today shows that Anthrax Vaccine, 

Adsorbed is at least as safe as any other vaccine currently in use today and 

its efficacy in preventing anthrax disease in persons exposed to 

aerosolized anthrax spores is high. Therefore, based on this risk-benefit 

analysis, the policy decision to implement the Anthrax Vaccine

Immunization Program is reasonable. 
30 . . . The Anthrax Vaccine Debate 
The Anthrax Vaccine Debate . . . 31 

VIII. Arguments Against Anthrax Vaccine, Adsorbed

A number of informational world-wide-web sites exist opposing the 

Defense Department’s Anthrax Vaccine Immunization Program to 

vaccinate military personnel against anthrax using Anthrax Vaccine, 

Adsorbed. One of the most comprehensive is entitled “Anthrax Vaccine 

Links and Information” and provides an extensive list of links to other 

related sites. Included are links to sites with copies of Congressional 

testimony, General Accounting Office reports, summaries of the 

symptoms reported by personnel at Dover Air Force Base, Delaware, who 

received Anthrax Vaccine, Adsorbed, press releases, and other documents

of interest.

121

While the internet has contributed to many improvements in our 

society, there are also dangers. The informational world-wide-web sites 

on anthrax have potential value, but they can also be the source of 

significant confusion and misinformation. For example, the debate over 

Anthrax Vaccine, Adsorbed has led to questions on the legality of Anthrax

Vaccine Immunization Program, implying military personnel are duty

bound to disobey it and that the mandatory program is a violation of their

civil rights.122 It is essential to sift through and gather the facts and look at 

both sides of a position before drawing any conclusions. In many ways, 

the availability of information on the internet, especially the free flow of 

ideas and opinions, makes critical, scientifically-based objective thought 

more difficult.123

It is important to note that the basic facts regarding the history of

development of Anthrax Vaccine, Adsorbed, Michigan Biological 

Products Institute, BioPort, Food and Drug Administration licensure, 

clinical results, etc., presented on internet web sites opposed to the 

Anthrax Vaccine Immunization Program are usually found within links to 

other sites containing on-line documents. These facts and documents 

generally match the information presented on the Defense Department 

anthrax informational web site.124 The difference is how the facts are 

presented, often with the insertion of subjective opinion and editorial 

comments, taking some point within the document referred to in the link 

out of context. 
32 . . . The Anthrax Vaccine Debate 

For example, one title says the Food and Drug Administration 

admits it has never received data on the long-term health effects. In reality 

this is a link to a letter the director of the Center for Biologics, 

Evaluations, and Research for the Food and Drug Administration wrote to 

the Executive Director for Veterans for Integrity in Government.125 The

letter responds to a series of questions, including whether or not any 

studies on the long-term health effects of Anthrax Vaccine, Adsorbed have

been performed. The letter actually says the data has not been submitted

to the Food and Drug Administration, but adds that for 28 years the 

vaccine had (at the time of writing) been used by veterinarians, laboratory 

personnel, industrial workers, and Food and Drug Administration 

inspectors. The clear intent of the answer is that the long-term health

effects data does exist but it has not been formally submitted to the Food 

and Drug Administration. 

One of the links on the “Anthrax Vaccine Links and Information” 

internet web site announces there have been British reports of outbreaks of 

Gulf War Syndrome after “recent” anthrax vaccinations. It references a 

British article entitled “Anti Bio-weapon Vaccine for troops Fails Safety 

Tests” from an independent British newspaper which reports newly 

produced lots of the British anthrax vaccine failed safety tests.126 The

article cites concerns from British Persian Gulf War veterans that the 

British version of the anthrax vaccine may have caused Gulf War 

Syndrome and that further use of the vaccine may cause more to develop 

symptoms. They claim many fell ill after recent vaccinations but the 

article provides no substantiating information. The article further alleges 

the lots used had expired and the shelf life had been extended several 

times.127

This link could be very misleading given the current debate about 

Anthrax Vaccine, Adsorbed since the article really is not about Anthrax 

Vaccine, Adsorbed. The British version of the anthrax vaccine is not 

Anthrax Vaccine, Adsorbed, is not produced either by Michigan 

Biological Products Institute or BioPort, does not require Food and Drug 

Administration licensure, and is not used in the United States. 

Furthermore, the Food and Drug Administration and British regulatory 

systems are completely separate. Yet the “Anthrax Vaccine Links and

Information” site contains no statements to make this distinction. 
The Anthrax Vaccine Debate . . . 33 

Many who are opposed to the Anthrax Vaccine Immunization

Program have attempted to connect the use of Anthrax Vaccine, Adsorbed

with Gulf War Syndrome in spite of the fact that no such causal

relationship has ever been demonstrated.128 Several headings of links on 

the “Anthrax Vaccine Links and Information” site seem to suggest a 

conspiracy theory with titles like “MOU: Defense Department’s & Food 

and Drug Administration’s Secret Deal.”129 In reality the document is the

memorandum of understanding outlining interagency cooperation for

medical research, outlining roles, responsibilities, and reporting 

procedures.130 The intent of the document is to ensure patient safety when

humans are involved in medical protocol studies. 

Many press release articles in the media either confuse facts, combine 

separate facts, or report facts in such a way as to be potentially 

incriminating. For example, an extensive article published in the Phoenix 

New Times states that anthrax vaccine production has been halted due to 

problems with the new BioPort production facilities.131 Actually,

Michigan Biological Products Institute voluntarily halted production in 

order to renovate the facility, then later sold the facility to BioPort. After

the sale, BioPort completed renovations but has had problems obtaining 

Food and Drug Administration certification of the renovated facility. 

While both facts are true, they are not directly, nor causally, related to 

each other as the Phoenix New Times article implies. This article also

attempts to raise concerns that there could be birth defects if a man who 

received Anthrax Vaccine, Adsorbed were to father a child. 

Another example is an Associated Press article entitled, “Food and 

Drug Administration inspection cites problems in vaccine production.”132 

A careful reading correctly indicates that the problems are with

certification of the renovated facilities, required before new batches of 

Anthrax Vaccine, Adsorbed may be sold. But, the last sentence of the 

article states several anthrax vaccine lots failed Food and Drug 

Administration potency testing. The article does not clarify that these 

were older lots, none of which have been used by the Defense Department. 

While the last statement is true by itself, there is no attempt to prevent 

confusion with statements regarding the recent Food and Drug 

Administration facilities inspection. This could lead one not familiar with

the facts to believe there is a direct relationship between the recent 
34 . . . The Anthrax Vaccine Debate 

inspections, lots of Anthrax Vaccine, Adsorbed that failed potency testing,

and the lots of vaccine currently in use by the Defense Department where, 

in fact, no such direct relationship exists. 

Other links seem intended to provoke an emotional response, such as 

one with photographs of injection sites with signs of local reactions 

entitled, “Painful Anthrax injection site photos...OUCH!” Others refer to

the numerous cases of individuals at Dover Air Force Base who claim to 

have developed symptoms after receiving Anthrax Vaccine, Adsorbed, 

claiming this proves the Defense Department really knows that the vaccine 

is not safe. And there are links to support groups and on-line chat rooms

where those opposed to the Anthrax Vaccine Immunization Program may 

discuss their views or tell their story. 

Interestingly, there are also links to other sites opposed to the use of 

other types of vaccines (e.g., hepatitis B vaccine) or all vaccines in

general. This suggests that those opposed to the use of Anthrax Vaccine,

Adsorbed and the Anthrax Vaccine Immunization Program are part of a 

larger movement opposed to the use of all vaccines, promoting an antivaccination agenda. Other links take an alarmist approach, warning what 

may happen to individuals who refuse to receive Anthrax Vaccine,

Adsorbed and giving advice and contact information if they “are being 

threatened with forcible innoculation (sic) of the Anthrax vaccine.”

133

Other examples abound and space does not permit a full analysis of 

all the links for and against the Defense Department’s anthrax vaccine 

immunization effort. Suffice it to say, the wording of the headings of the 

links combined with selective reporting could potentially influence the 

opinions of readers who have not had the opportunity to familiarize 

themselves with all the facts. It is important for commanders and 

supervisors to be aware that these information sites are intentionally 

biased, presenting information in a way to substantiate a preconceived 

notion or opinion against the use of Anthrax Vaccine, Adsorbed.134 When

referring to such sites, it is worthwhile to keep the biased nature of these 

sites in mind and spend some extra time to read the source documents 

these sites claim substantiate their opinions. 

At the forefront of the opposition to the Defense Department’s 

Anthrax Vaccine Immunization Program is an emergency room physician 

from Maine, Dr. Meryl Nass, regarded by opponents to the program as an 
The Anthrax Vaccine Debate . . . 35 

expert on anthrax and Anthrax Vaccine, Adsorbed.135 She has written a 

number of articles on these subjects and testified before Congress several

times against the Anthrax Vaccine Immunization Program. For example, 

one link on the “Anthrax Vaccine Links and Information” site makes the

claim that the Defense Department really does know the anthrax vaccine is 

not safe. It turns out the link leads to an unpublished article written by Dr. 

Nass about an informational meeting for 100 physicians at Fort Detrick, 

Maryland, in May 1999 where issues about Anthrax Vaccine, Adsorbed 

were discussed. Her article implies that military physicians asking policy 

questions about Anthrax Vaccine, Adsorbed and the Vaccine Adverse 

Events Reporting System proves the Defense Department does in fact 

know the vaccine is not safe. She ends by admonishing the readers to 

contact their congressional representatives. 

Dr. Nass also has her own informational world-wide-web home page

about anthrax.136 The “Anthrax Vaccine Links and Information” site lists

her credentials, which includes three years experience studying the anthrax 

outbreak in Zimbabwe.137 She is quoted as saying as many as 10 percent 

of those receiving Anthrax Vaccine, Adsorbed have gotten sick, although 

there is no explanation of what that means–whether the symptoms were 

mild, moderate, severe, localized, or systemic.138

In 1999, Dr. Nass published an article reviewing the anthrax vaccine 

and its potential protective value against a biological attack with 

weaponized anthrax.139 While extensively researched and documented, 

she cites sources that are of questionable veracity. For example, she

alleges the Defense Department may have attempted to increase the

potency of Anthrax Vaccine, Adsorbed by secretly adding squalene, citing 

herself as the source by referring to a letter she wrote to the Army Surgeon 

General in May 1998.140 Based on this allegation, she implies a potential

connection between Gulf War Syndrome and Defense Department 

vaccination programs, including Anthrax Vaccine, Adsorbed, which is the 

basis for most of the concern with the safety and efficacy of the vaccine. 

She also states in this article “the present human anthrax vaccine 

probably provides only limited protection for troops facing a BW (sic) 

attack by anthrax.”141 She bases this assertion on the lack of controlled 

studies in humans that investigate the clinical effectiveness of Anthrax 

Vaccine, Adsorbed against inhalation anthrax during a biological attack. 
36 . . . The Anthrax Vaccine Debate 

Yet she presents no clinical data of her own to substantiate her claim that 

Anthrax Vaccine, Adsorbed may not be effective in preventing inhalation

anthrax after a biological attack. In other words, in her opinion, the more

than 30 years of clinical data from field trials of anthrax vaccine in 

workers exposed to anthrax; the absence of inhalation anthrax in the 

workplace since 1978; and the animal studies that demonstrate Anthrax 

Vaccine, Adsorbed’s effectiveness in preventing inhalation anthrax, are 

not enough to conclude the vaccine may prevent inhalation anthrax after 

an attack. Instead, she implies the only way to justify using Anthrax 

Vaccine, Adsorbed to protect against inhalation anthrax would be to 

design and conduct a study in which humans are deliberately exposed to 

aerosolized anthrax spores. 

In another document on her web site entitled “Adverse Effects: 

Anthrax Vaccine,” Dr. Nass discusses the rates of adverse effects of

Anthrax Vaccine, Adsorbed.142 In this document, she refers to the Pittman

and Tripler data discussed earlier, but generalizes the data on systemic 

reactions into one category. She states Pittman reported a systemic 

reaction rate of 43 percent and local reaction rates of 21 percent with 5

percent for moderate or severe local reactions, respectively. Referring to 

the Tripler report, she cites a 48 percent systemic reaction rate and local 

reaction rates of 80 percent overall, but does not report the rate for 

moderate and severe local reactions. She cites as her sources the General 

Accounting Office Congressional testimony given 29 April 1999 and 12 

October 1999. 

During his 29 April 1999 testimony before Congress, Kwai-Cheung 

Chan, Director, Special Studies and Evaluations, National Security and 

International Affairs Division, the General Accounting Office, referred to 

data from four safety studies involving Anthrax Vaccine, Adsorbed.143 

Included are tables clearly distinguishing between mild versus 

moderate/severe systemic reactions. Whereas Dr. Nass claims the Pittman

study showed an occurrence rate of 43 percent for systemic reactions to 

Anthrax Vaccine, Adsorbed, the Pittman study actually distinguishes 

between occurrence rates for mild (29 percent) and moderate/severe (14

percent) systemic reactions. Similarly, the Tripler study, in which Dr. 

Nass says there was an occurrence rate of 48 percent for systemic 

reactions, actually reported that the rate of moderate or severe systemic 
The Anthrax Vaccine Debate . . . 37 

reactions was 5 percent while the rate for mild systemic reactions was 43

percent.144

The numbers involved in the Pittman and Tripler studies are very low,

roughly 500 for each. Recall that the Canadian Armed Forces study 

involved 547 participants, but in that study the occurrence rates for 

systemic reactions were lower than the rates listed in the Food and Drug

Administration package insert for Anthrax Vaccine, Adsorbed. Other 

studies already cited, involving tens of thousands of participants, also 

document systemic reaction rates that are much lower, especially for 

moderate and severe reactions, suggesting the Pittman and Tripler studies

may not be statistically valid. Distinguishing between mild versus 

moderate and severe systemic reactions and accounting for the low 

numbers involved in these two studies is important. Not making these 

distinctions, plus attempting to build a case on data that may be 

statistically limited, could inadvertently mislead those not familiar with

the actual studies to conclude the risk from Anthrax Vaccine, Adsorbed is

higher than is actually the case. 

Dr. Nass, in her article on adverse effects, is highly critical of the 

effectiveness and accuracy of the Vaccine Adverse Events Reporting

System data for Anthrax Vaccine, Adsorbed and the Anthrax Vaccine

Immunization Program, believing that the rate of reporting data by 

Defense Department health care workers is low. She alleges that Defense

Department health care workers and physicians were ordered not to report 

any but the most severe reactions and not to report any symptoms or 

reactions not specifically listed in the Food and Drug Administration 

package insert for Anthrax Vaccine, Adsorbed.145 She gives no source or 

substantiating documentation for this allegation. She also states that the 

package insert for Anthrax Vaccine, Adsorbed, as required by the Food 

and Drug Administration, was written using only information from the

Brachman study vaccine, the precursor of Anthrax Vaccine, Adsorbed.

And she asserts the Brachman study is the only study with “published” 

reaction rates for anthrax vaccine. 

The purpose of the Vaccine Adverse Events Reporting System is to 

gather ongoing, long-term data on potential adverse reactions due to 

vaccines that were not identified during limited clinical trials. For 

example, if the incidence of a particular reaction or severe systemic effect 
38 . . . The Anthrax Vaccine Debate 

occurring is one in a million, then several hundred thousand or even

several million doses may have to be administered before that reaction 

would be observed. In reality, such extensive, long-term studies are not 

possible during clinical trials. Furthermore, if evidence exists that the 

vaccine will prevent more disease and save more lives than any harm 

caused by the vaccine, it may be regarded as unethical to withhold the 

vaccine from market to conduct long-term studies. The Food and Drug 

Administration instituted the Vaccine Adverse Events Reporting System 

to continue to collect data over the long-term, after vaccines are released 

for sale, to look for extremely rare adverse effects even though initial 

studies indicate a vaccine is safe and effective. 

The Vaccine Adverse Events Reporting System is a passive reporting

system, meaning that individuals must take the initiative to file a report.146 

There is no one that actively calls or surveys vaccinated individuals to see

if they developed any symptoms. In some cases this could be a 

disadvantage, leading to low reporting rates. Also, it is not possible just 

by using this data to establish that a particular vaccine actually caused an 

event. But, through the identification of possible trends over the long term, 

Vaccine Adverse Events Reporting System data is useful to direct new 

clinical studies to establish causality.

Several facets have been built into the Vaccine Adverse Events 

Reporting System to facilitate reporting. For example, anyone, including 

patients and families, may report any symptom suspected due to a vaccine. 

In addition, medical personnel are routinely reminded through extensive

educational programs about the need to report to this database. 

Furthermore, medical personnel are required to report adverse effects due 

to vaccines to the manufacturer who is then required to report those events

to Vaccine Adverse Events Reporting System.

147

The Vaccine Adverse Events Reporting System receives over 12,000 

reports of possible adverse reactions to vaccines each year. Fifteen 

percent are considered serious, including those that are life-threatening, 

result in hospitalization, missed work, or permanent disability. It should 

be noted that for some childhood vaccines, more reports of potential 

adverse effects from the vaccine are filed each year than the number of

reported cases of the disease the vaccine is designed to prevent.148 This

cumulative evidence suggests that, contrary to the criticisms of Anthrax 
The Anthrax Vaccine Debate . . . 39 

Vaccine Immunization Program opponents, the Vaccine Adverse Events 

Reporting System is highly successful. 

The Defense Department has reiterated to medical personnel that they 

should report any events they feel may be due to Anthrax Vaccine, 

Adsorbed. There is no documentation that the Defense Department 

instructed medical personnel to file a report only when they observe the 

side effects and reactions listed in the Food and Drug Administration 

package insert.149 Instead, the Defense Department encourages all 

medical personnel to report all events potentially thought to be related to 

Anthrax Vaccine, Adsorbed and requires them to report to the Vaccine 

Adverse Events Reporting System all adverse reactions potentially 

associated with the vaccine resulting in hospitalization or loss of more 

than 24 hours duty.150 Additionally, in 1999, the Air Force Surgeon 

General directed that any adverse events even suspected by medical

personnel to be related to Anthrax Vaccine, Adsorbed will be reported to 

the Vaccine Adverse Events Reporting System.

151 Dr. Nass’ allegations

that Defense Department physicians are prohibited from filing reports to 

the Vaccine Adverse Events Reporting System on any potential Anthrax 

Vaccine, Adsorbed related event are completely unfounded, ignoring the 

fact that such prohibitions may be illegal. 

As already discussed, licensure of Anthrax Vaccine, Adsorbed (and 

the information for the package insert) was based on both the Brachman 

study and data collected by the Centers for Disease Control and 

Prevention over a 10-year period on the use of Anthrax Vaccine, Adsorbed 

in workers considered at risk for exposure to anthrax spores. Furthermore, 

the Brachman study is not the only place where data on the safety and 

efficacy of Anthrax Vaccine, Adsorbed has been published. As already 

noted in this paper, there have been numerous other studies (e.g., the 

Centers for Disease Control and Prevention study) on the safety and 

efficacy of Anthrax Vaccine, Adsorbed conducted over several years 

involving tens of thousands of human subjects.152

Although not all of these studies are individually published as peerreviewed articles (like the Brachman study), the data collected by these 

studies has been examined by review panels and published in several 

articles that have undergone the peer-review process.153 Stating that the 

Brachman study contains the “ONLY published adverse reaction rates” 
40 . . . The Anthrax Vaccine Debate 

without acknowledging these other sources of data in the peer-reviewed 

literature is misleading.154

Another concern raised by opponents to the Anthrax Vaccine 

Immunization Program is that adversaries might develop strains of anthrax 

that are resistant to Anthrax Vaccine, Adsorbed.155 Some base this on the

fact that strains of anthrax have been developed that are resistant to 

antibiotics. Also, there have been reports that anthrax strains have been 

developed that may render the Russian-developed live attenuated vaccine 

ineffective.156 Neither of these reports mean that a strain of anthrax has

been produced that is resistant to Anthrax Vaccine, Adsorbed. 

First, it must be pointed out that developing resistance to antibiotics is 

not the same as developing resistance to vaccines. Antibiotics

(biochemicals produced in nature or synthesized in laboratories that are 

toxic to bacteria) are completely different from antibodies (complex 

proteins produced by the inoculated individual’s immune cells) that result 

from vaccination. Bacteria commonly develop resistance to antibiotics 

through several naturally occurring mechanisms, resulting in the antibiotic 

(such as penicillin or tetracycline) no longer being toxic to the bacteria. 

Anthrax Vaccine, Adsorbed, however, induces the inoculated

individual to produce antibodies against protective antigen, which also is a 

protein. In order for anthrax to develop a resistance to the vaccine, the 

bacteria’s genetic code for protective antigen would have to be altered in 

such a way so the bacteria produces an altered version of protective 

antigen that the antibodies cannot recognize. But the protective antigen 

would still have to retain its functional ability to combine with the host’s 

cells and the other anthrax toxins (which are also proteins made by anthrax 

bacteria) to produce disease. 

An adversary intent on producing a strain of anthrax resistant to 

Anthrax Vaccine, Adsorbed would, therefore, need to possess highly

sophisticated and very expensive genetic engineering capabilities. 

Needless to say, any genetics program intended to alter anthrax to change

the characteristics of protective antigen would be a costly monumental 

undertaking and well beyond the reach of most potential adversaries. Not 

surprisingly, there is no documentation that a strain of anthrax consistently 

resistant to Anthrax Vaccine, Adsorbed in all species has been 

produced.157
The Anthrax Vaccine Debate . . . 41 

No vaccine is perfect, meaning that no vaccine is 100 percent safe and 

effective. But, as has been presented, the clinical evidence suggests 

Anthrax Vaccine, Adsorbed is safe and effective–probably safer with 

lower rates of side effects than other vaccines in use today. But, even 

though Anthrax Vaccine, Adsorbed is safe and effective, that does not 

mean there is no room for improvement regarding vaccinations against 

anthrax.158

The requirement for six inoculations with Anthrax Vaccine, Adsorbed

creates a significant logistical problem for the Defense Department’s 

Anthrax Vaccine Immunization Program, especially as supplies of 

currently re-tested and approved lots of vaccine are running low. But, the

current requirement for six inoculations is in accordance with the Food 

and Drug Administration licensure of Anthrax Vaccine, Adsorbed and 

probably won’t change unless studies are done to confirm that the vaccine

provides protection with fewer doses. Newer vaccines that require fewer 

doses to confer immunity have been developed but have not been

approved for use by the Food and Drug Administration.159 The 30 percent 

rate of occurrence of local reactions ideally could be lower, although it has 

already been pointed out that this rate is already lower than other vaccines

currently required by the Defense Department. 

A major challenge is how to demonstrate an individual has developed 

adequate immunity against anthrax after vaccination either with Anthrax

Vaccine, Adsorbed or a newer anthrax vaccine without exposing the 

individual to aerosolized anthrax spores. As discussed previously, it is not 

ethical to expose individuals to aerosolized anthrax spores to see if the 

vaccine prevents development of inhalation anthrax. Using animal models 

may or may not be useful since species differ in their sensitivity to anthrax 

and differences in their immune systems may alter the efficacy with which 

anthrax vaccines confer immunity. Measuring the level of antibodies an 

individual has circulating in the blood against protective antigen has been 

shown to be a very unreliable measurement of immunity against anthrax. 

The next best approach would be to develop a test that could be 

administered to the individual to indicate the degree of immunity. 

Currently no such test exists, which is one reason why the Food and Drug 

Administration recommends a series of six shots of Anthrax Vaccine,

Adsorbed with an annual booster. With such a test, individuals could be 
42 . . . The Anthrax Vaccine Debate 

screened and only those with inadequate immune responses would require 

supplemental inoculations, potentially decreasing the required number of 

doses of vaccine. 

It should be reiterated, however, that even though there is room for 

improvement, none of these issues negate the current value and 

effectiveness of Anthrax Vaccine, Adsorbed. In contrast, Dr. Nass warns

that submitting to the Anthrax Vaccine Immunization Program is like

playing Russian roulette with your life since there is the possibility there 

could be side effects.160 But, following this line of reasoning, one should 

never receive any vaccine (or take any other medication or undergo any 

medical procedure for that matter) since all vaccines have risks associated

with their use and no vaccine is totally risk-free. 

Dr. Nass believes there should be more emphasis on using alternatives 

to vaccination with Anthrax Vaccine, Adsorbed to protect troops from 

anthrax. For example, she suggests there should be more emphasis on the 

use of protective equipment. The problem with this approach is, due to 

the lack of real-time detection capability, there is no way for personnel to 

know when they need to wear the protective equipment, meaning they 

would have to wear it continually to be effective.

Dr. Nass also expresses concern that immunizing troops against 

anthrax may provoke an adversary to simply pick another agent.161 As

previously discussed, other biological agents are more difficult to 

weaponize and the likelihood that other agents would be used in an attack 

instead of anthrax is much lower. 

Dr. Nass also expresses hope that creation of and adherence to better 

international biological weapons conventions, including provisions for 

surprise inspections and stiff penalties for non-compliance, will improve 

nonproliferation efforts. Sadly, there is ample historical evidence that

several signatory nations have already violated current nonproliferation 

arms control agreements like the Nuclear Nonproliferation Treaty, in spite 

of provisions for “on-site” inspections.162

Another writer goes as far as to suggest there should not be any 

vaccinations of Defense Department personnel until an anthrax-based

biological weapon is actually used, even though he acknowledges that 

historical precedent exists to justify concern that anthrax could be used as

a political tool.163 This reactionary approach ignores the ready availability 
The Anthrax Vaccine Debate . . . 43 

of anthrax spores and that anthrax is easily weaponized and that some

states of concern like Iraq, have been proved to have done so. 

Recall also, that there are limitations associated with constant use of 

personal protective gear, that there are limitations with gathering 

intelligence to provide advanced warning of an attack, and that no means 

exists to detect reliably that an attack with anthrax is occurring. 

Considering that international conventions historically have failed to 

prevent proliferation of biological weapons (even in spite of on-site 

inspections), and that it takes time for an individual to develop an 

immunity against anthrax after vaccination, it becomes apparent that 

waiting until an attack is imminent before immunizing personnel would 

not only be ineffective, but dangerous.164 Consequently, immunization 

against anthrax before an attack becomes imminent is still our best proactive defense to protect personnel from attacks using anthrax-based 

biological weapons. 

At Dover Air Force Base, Delaware, the number of individuals 

reporting adverse reactions after inoculation with Anthrax Vaccine, 

Adsorbed appears to exceed the rate one would expect based on the 

published literature. A list of many of the symptoms reported can be 

found on the world-wide-web.165 There are several problems, however, 

trying to make a connection between these symptoms and Anthrax 

Vaccine, Adsorbed. First of all, there is no discernable pattern to the 

symptoms. The time of onset between vaccination and the onset of 

symptoms is highly variable, ranging from a few hours to months. The

listings on the web site do not indicate if these patients got better, except 

in one or two cases. 

From a statistical perspective, after almost 40 years of clinical 

experience with Anthrax Vaccine, Adsorbed, plus several studies

documenting its safety, why would there be this sudden cluster of cases at 

Dover? By way of contrast, the U.S. Army Medical Research Institute of 

Infectious Diseases tracked 1,590 individuals who received 10,451 doses 

of Anthrax Vaccine, Adsorbed over several years, documenting rates of 

adverse events no higher than those listed in the Food and Drug 

Administration package insert and no loss of duty.166

With no recurrent pattern of symptoms, and no consistent temporal

relation of the development of symptoms to inoculation with Anthrax 
44 . . . The Anthrax Vaccine Debate 

Vaccine, Adsorbed, it is extremely difficult to claim the cases at Dover 

prove Anthrax Vaccine, Adsorbed is the cause.167 In addition, the rate of

occurrence of any disease (for example thyroid disease) in vaccinated 

personnel at Dover is equal to or less than the rate of occurrence of the 

same disease in unvaccinated individuals. And the rate of occurrence of 

individual symptoms in personnel vaccinated with Anthrax Vaccine, 

Adsorbed is no higher than the rate expected when vaccinating personnel 

with any other vaccine, further complicating claims that Anthrax Vaccine, 

Adsorbed caused the symptoms.

168

Without a doubt it would be wrong to trivialize the symptoms these 

patients are experiencing. The symptoms are very real and must be 

addressed in a compassionate, professional manner. But, the fact that 

these individuals are having symptoms and the fact that they received 

Anthrax Vaccine, Adsorbed does not prove that the vaccine caused the 

symptoms. In contrast, it is more likely these individuals would have 

developed the symptoms from which they currently suffer even if they had 

not received the vaccine.

The debate over Anthrax Vaccine, Adsorbed has led to introduction of 

a bill in Congress that would suspend the Defense Department’s Anthrax 

Vaccine Immunization Program.

169 Much of the language of the bill cites 

language similar to the language found on the “Anthrax Vaccine Links

and Information” site. The bill would also prohibit the gathering of any 

data whatsoever on adverse effects potentially related to Anthrax Vaccine, 

Adsorbed. 

This prohibition is indeed unfortunate for three reasons. First, there is

nothing unethical about collecting data while the Anthrax Vaccine 

Immunization Program is in effect. Second, the Defense Department 

would not be able to collect the vast amount of valuable data that could be 

used to resolve the issues and concerns that led to the introduction of the 

bill. Third, the bill ignores the relative risks of not vaccinating Defense

Department personnel (including the real risk that military personnel could 

be attacked with an anthrax weapon and the lethality of inhalation anthrax)

versus the large amount of clinical data documenting Anthrax Vaccine, 

Adsorbed’s safety and efficacy. 

Lieutenant General (retired) James T. Scott recently wrote an

editorial which, arguably, does more to place the entire controversy over the 
The Anthrax Vaccine Debate . . . 45 

Defense Department’s anthrax vaccination into proper perspective than

any other work examined in this paper.170 He states that both sides share

the blame for escalating this debate out of proportion. The Defense 

Department could have done better stating its case in the beginning for a 

comprehensive vaccination program in peacetime. The Defense 

Department’s credibility had already been damaged by how it handled the 

Agent Orange and Gulf War Syndrome issues. This problem is 

exacerbated by the chronic under-funding of the military health care 

system that is eroding away what little confidence beneficiaries may have 

in military health care. And the Defense Department failed to anticipate

the effect the internet would have on spreading dis-information campaigns 

against the Anthrax Vaccine Immunization Program.

To the opponents who are also Service members, Scott writes that it is 

time to find out the facts. He states Service members concerned over the 

Defense Department’s Anthrax Vaccine Immunization Program should be 

sure the information they possess is based on solid facts. He admonishes 

those opposed to the Immunization Program to ask themselves if they are 

only concerned with the safety and efficacy of Anthrax Vaccine, Adsorbed 

or if their concerns run much deeper–that their opposition to the Anthrax 

Vaccine Immunization Program may reflect that they have lost complete 

confidence in the military system. If so, it may be time for them to find a 

career outside the military. 

To military leaders and supervisors, Scott says the controversy over

the Defense Department’s Anthrax Vaccine Immunization Program is not 

a test of leadership. The ability to talk subordinates into vaccination 

versus court-martialing those who refuse is a false test and misses the 

point. The real issue is how they will restore their subordinates’

confidence in the mission, the chain of command, the unit, and each other. 

This confidence should be based on “rational explanations based on 

credible evidence.”171 In an all-volunteer force of such high quality 

people, the “men and women who serve in our armed forces deserve no

less.”172
46 . . . The Anthrax Vaccine Debate 
The Anthrax Vaccine Debate . . . 47 

IX. Conclusions and Recommendations 

The current anthrax vaccine, Anthrax Vaccine, Adsorbed, is a 

licensed vaccine and has been demonstrated to be clinically safe and 

effective for preventing inhalation anthrax after exposure to anthrax 

spores. Based on the findings of the 1985 advisory review panel 

examining the safety and efficacy of Anthrax Vaccine, Adsorbed, the 

Food and Drug Administration categorized the vaccine as a “Category 1 

(safe, effective, and not misbranded) vaccine.”173 In spite of the existing

documentation of the safety and efficacy of Anthrax Vaccine, Adsorbed, 

the Defense Department continues to ask outside consultants and panels to 

review the evidence documenting the safety and efficacy of the vaccine. 

For example, recently the Defense Department asked the Institute of

Medicine to review all available data on Anthrax Vaccine, Adsorbed.

174 

One would be hard pressed to identify another vaccine in use today that 

has undergone more scrutiny than Anthrax Vaccine, Adsorbed. 

There are significant issues with Anthrax Vaccine, Adsorbed that 

should be addressed, including the current dosage regimen (requiring six 

doses with annual booster shots), the inability to specifically measure the 

level of immunity an individual may already possess, and the occurrence 

of local reactions in 30 percent of those who are vaccinated. In spite of 

these issues, there is no clinical evidence that the Defense Department’s 

Anthrax Vaccine Immunization Program to vaccinate personnel 

considered to be at risk for exposure to anthrax should be stopped. The

risk of serious adverse reactions or permanent injury from Anthrax 

Vaccine, Adsorbed is no higher than (and, in fact, is probably lower than) 

that for any other vaccine commonly in use in the general population 

today. In contrast, the risks to military personnel from the threat of attack 

with an anthrax-based biological weapon, plus the high lethality of 

inhalation anthrax, far outweigh the risks associated with vaccination. 

The large number of doses of Anthrax Vaccine, Adsorbed required to

establish immunity, plus the annual requirement for a booster, create 

significant problems in terms of logistics and costs for the Defense 

Department to complete the Anthrax Vaccine Immunization Program and 

vaccinate all Defense Department personnel, especially in light of 

dwindling supplies of vaccine. Ideally, a reliable test to measure an 

individual’s immunity against anthrax should be developed. To ease the 
48 . . . The Anthrax Vaccine Debate 

burden, only personnel expected to deploy to areas where the risk for

potential use of weaponized anthrax is highest should be vaccinated. 

Military personnel not expected to deploy to these areas are at no greater

risk for exposure to weaponized anthrax spores than the general 

population of the United States, and need not be vaccinated. This is

consistent with consensus panel recommendations that there is no 

requirement to vaccinate the entire population of the U.S. since the risk of 

exposure to weaponized anthrax for any given community within the U.S. 

is extremely low.175

The U.S. Army Medical Research Institute of Infections Diseases 

completed pre-clinical research on a next-generation anthrax vaccine 

several years ago. The new recombinant vaccine is now in advanced 

clinical development. Unfortunately, Food and Drug Administration 

approval of a new vaccine is still several years away. In the meantime, 

long-term data collection studies should continue in order to document

further the safety of Anthrax Vaccine, Adsorbed and attempt to identify

extremely rare adverse effects which may only become apparent after 

millions of doses of vaccine have been administered. The Defense 

Department should also continue with programs to provide long-term 

follow-up to individuals claiming to have developed symptoms after 

receiving Anthrax Vaccine, Adsorbed. These patients’ symptoms are real 

and they deserve compassionate, professional medical care. 

Continuance of the Anthrax Vaccine Immunization Program should 

include an aggressive, active educational and informational program designed 

to address concerns at all levels, from the top leadership down to the 

installation level. The Defense Department web site and its links to other 

Service-specific web sites are excellent but passive, meaning they depend on 

people going to these sites to get the facts. What is needed is an active 

education program where information is actively taken out to the troops. 

Defense Department programs actively promoting education of all 

military personnel, using the information on the Defense Department 

internet web site, could significantly alleviate the suspicions and doubts

currently surrounding the Anthrax Vaccine Immunization Program. 

Commander and supervisor involvement at every level of command is 

essential to begin rebuilding the confidence military personnel should 

have in their chains of command. 
The Anthrax Vaccine Debate . . . 49 

Commanders and supervisors should be aware of the biased nature of

informational internet web sites opposed to the Anthrax Vaccine

Immunization Program, emphasizing to their personnel the importance of 

basing any conclusions about Anthrax Vaccine, Adsorbed or the Anthrax 

Vaccine Immunization Program on all the facts. Such proactive 

educational efforts should prove useful to reverse any negative trends and

perceptions emanating from the Defense Department’s handling of the 

Agent Orange and Gulf War Syndrome issues. The Anthrax Vaccine 

Immunization Program should be viewed as an opportunity for the 

Department of Defense to demonstrate its commitment to maintaining the

health and safety of Service personnel while countering any threat to our 

nation’s security from anthrax-based mass-casualty weapons. 
50 . . . The Anthrax Vaccine Debate 
The Anthrax Vaccine Debate . . . 51 

Notes 

1. Major Sonny Bates’ home page is found at http://www.majorbates.com/. 

2. The Air Force eventually allowed Major Bates to resign his commission. See 

Representative Dan Burton, Letter to Secretary of Defense William Cohen, 12 May, 

2000, on-line, internet, 27 August 2000, available from http://www.house.gov/reform/

letters/cohen.5.12.00.pdf.

3. Dr. Robert C. Myers, Statement Presented to the Subcommittee on National

Security, Veterans Affairs, and International Relations, 29 April 1999, on-line, internet,

11 February 2000, available from http://www.bioportcorp.com/testimony_

of_drmyers.htm. 

4. This is the approach used in an article recently published by Mazzuchi, et al. In 

this article the authors emphasize that the decision to immunize is a command policy

decision even though maintaining the health of the Service members is the primary

objective. See John F. Mazzuichi, Robert G. Claypool, Kenneth C. Hyams, David

Trump, James Riddle, Relford E. Patterson, Sue Bailey, “Protecting the Health of U.S. 

Military Forces: A National Obligation,” “Aviation, Space, and Environmental

Medicine,” 71, no. 3 March 2000, 260-265. 

5. Peer-reviewed “refers to the process major medical journals use to decide if

submissions are worthy of publication. Normally, the lead investigator submits a 

manuscript for consideration to the editorial board. The editorial board then selects 

members of the board (unknown to the author of the manuscript) to review the article to 

see if it meets stringent criteria such as scientific process, experimental design, analysis

of the data, discussion, and conclusions. Some journal editorial boards “blind” the

editorial reviewers and authors from each other so the reviewers and authors do not know 

whose work is being reviewed to make the review process more objective. The peerreview process is considered to be the most effective means of assuring quality 

publications in the medical literature. It should be noted that medical textbooks are not

peer-reviewed although there is an editor to whom writers of the individual book chapters 

submit their manuscripts. Therefore, publishing in a textbook is not considered to be as

significant as publication in a peer-reviewed journal.

6. Numerous extensive reviews of the disease process of anthrax, the vaccine, and 

the threat weaponized anthrax poses to United States military personnel already exist in

the literature. Many are cited in this paper. 

7. Numerous countries, including those who are signatories of the Biological

Weapons and Toxins Convention (including the former Soviet Union and Iraq) are

known to have offensive biological weapons development programs, including 

development of weapons using anthrax as the agent. Major D. L. Clements, in an 
52 . . . The Anthrax Vaccine Debate 

interesting study, concludes that overt use of tactical biological agents on the battlefield is 

unlikely due to difficulty in hiding the identity of the attacker and the risk of 

overwhelming response. Biological attacks against United States forces overseas are, in 

his opinion, more likely to be on a small scale by terrorist groups. He identifies anthrax

as the ideal biological warfare agent and concludes its use by terrorists or covert 

operators (such as special forces) against U.S. forces either in the U.S. or overseas is

highly plausible, especially during deployments. See Major David Lee Clement, “A 

Determination of the Military Significance of Modern Biological Warfare,” Master’s 

Thesis, U.S. Army Command and General Staff College, Ft. Leavenworth, KS, 1993, 70,

79. See also Thomas V. Inglesby, et al, “Anthrax as a Biological Weapon,” Journal of the

American Medical Association, 281, no. 18, 12 May 1999, 1735-1745. This article states 

that anthrax is one of the most serious agents that could be used as a biological weapon,

presenting a clinical discussion of anthrax to demonstrate why it would make such an

effective weapon. Mazzuchi, et al, op. cit., 261. For more information related to the 

threat anthrax poses as a potential biological weapon, the reader is referred to the United 

States Air Force Counterproliferation Center’s world-wide-web site at 

http://www.au.af.mil/au/awc/awcgate/awc-cps.htm which is updated regularly and 

contains numerous links to other important sites on this topic. 

8. For more detailed information, the reader is referred to the Defense Department’s

informational world-wide-web site addressing anthrax vaccination at http://www.anthrax. 

osd.mil/. This site includes several links to papers, covering a variety of issues related to

the anthrax vaccine. There are also several web sites outlining the reasons against the 

Defense Department’s anthrax vaccination program. The most prominent and complete 

with numerous links to other sites is http://www.dallasnw.quik.com/cyberella/index.htm.

It is important to note that these sites present nearly identical historical, clinical, and

factual information. Where these sites differ is how they interpret the information and

what conclusions they draw. 

9. The Gram stain is a special stain invented by and named for Christian Gram.

Bob A. Freeman, “The Physical and Chemical Structure of Bacteria,” Burrows Textbook 

of Microbiology, 21st Edition, (Philadelphia, PA: W.B. Saunders Company, 1979), 25. 

Used to classify bacteria when looking through a microscope. Gram positive bacteria

absorb a crystal violet stain, turning it deep violet in color, whereas Gram negative

bacteria do not.

10. Terry C. Dixon et al, “Anthrax,” The New England Journal of Medicine, 341,

no. 11, 9 September 1999: 815-826. 

11. R. K. Holmes, “Diptheria, Other Cornybacterial Infections, and Anthrax,” in

Harrison’s Principles of Internal Medicine, 14th edition, eds. Anthony S Fauci, M.D. et

al. (New York, NY: McGraw-Hill, 1998), 897. See also, Phillip S. Brachman, 

“Anthrax,” in Infectious Diseases 3rd edition, edited by Paul D. Hoeprich, M.D. 

(Philadelphia, PA: Harper & Row, Publishers, 1983), 939. 
The Anthrax Vaccine Debate . . . 53 

12. Thomas V. Inglesby et al, “Anthrax as a Biological Weapon,” Journal of the

American Medical Association, 281, no. 18, 12 May, 1999, 1735-1745.

13. “Anthrax History: What You Need to Know,” on-line, internet, 11 February

2000, available from http://www.anthrax.osd.mil/. 

14. Daniel Lew, “Bacillus Anthracis,” in Principles and Practice of Infectious

Diseases, 4th ed., vol. 2, eds. Gerald l. Mandell, John E. Bennett, and Raphael Dolin,

editors, (New York, NY: Churchill Livingstone, 1995), 1885. 

15. Kenneth W. Hedlund, “Anthrax Toxin: History and Recent Advances and 

Perspectives,” Journal of Toxicology 11, no. 1, 1992, 41-88. 

16. Holmes, op. cit., 897. 

17. Brachman, op. cit., 944. 

18. Inglesby, 1736. 

19. Holmes, op. cit., 897. 

20. Brachman, op. cit., 940. 

21. Ibid., 943. 

22. Ibid., 942. 

23. Inglesby, op. cit., 1737. 

24. Dixon, op. cit., 819. 

25. Inglesby, 1737. 

26. Ibid., 1774. 

27. Ibid., 1736-1737. 

28. Ibid., 1743-1744. See also a paper written as part of a series entitled, “The

Military Readiness Project,” sponsored by the Family Research Council. See George T. 

Havrilak, “The Pentagon’s Anthrax Vaccination Immunization Program,” (no date), n.p.,

on-line, internet, 9 September 2000, available from http://www.frc.org/military/ 

mp99k1mf.html. 

29. Dixon, op. cit., 818. 

30. “Hemorrhagic meningitis” refers to inflammation of the protective coverings of

the brain and spinal cord with associated bleeding. 
54 . . . The Anthrax Vaccine Debate 

31. Ibid., 819. 

32. Arthur M. Friedlander, “Anthrax,” in Textbook of Military Medicine: Medical

Aspects of Chemical and Biological Warfare, eds. Brigadier General Russ Zajtchuk and

Ronald F. Belamy, (Washington, DC: TMM Publications, 1997), 470. 

33. Ibid., 815-818. See also, Hedlund, op. cit., 53. 

34. Antibiotics and antibodies are completely different. Antibiotics are chemicals

not produced by the body that either kill or inhibit the growth of bacteria. Antibodies are 

complex proteins produced by the body that circulate in the blood and recognize foreign 

substances. Bacterial resistance to antibiotics means that bacterial growth is not affected

by that particular antibiotic. It does not imply the bacteria are resistant to antibodies. 

35. Inglesby, op. cit., 1741. 

36. “Approved of CIPRO® For Use After Exposure to Inhalational Anthrax,” 31 

August 2000, on-line, internet, 3 November 2000, available from http://www.fda.gov/

bbs/topics/ANSWERS/ANS01030.html. 

37. Ideally, the antibiotics should be administered intravenously and later switched 

to oral medications if the patient remains asymptomatic. But, if there are large numbers

of patients or limited medical facilities, oral administration is acceptable. Antibiotic 

treatment should be continued either for 60 days or until the possibility of exposure to 

anthrax has been completely and positively excluded through testing. If the anthrax 

vaccine is available and possible exposure to anthrax confirmed, it is reasonable to give

these patients the anthrax vaccine. If these patients remain asymptomatic, then the course

of antibiotics may be reduced to 30 to 45 days. Inglesby, op. cit., 1741-1743. 

38. There are two different types of anthrax vaccine in existence today for human 

use. (“An Assessment of the Safety of the Anthrax Vaccine: A Letter Report,” 30 March, 

2000; on-line, internet, 12 August 2000, available from http://www.nap. 

edu/html/anthrax_vaccine/.) Vaccines manufactured by filtering and purifying protective

antigen (such as AVA) are used in the West, primarily by the U.S. and the United

Kingdom. The former Soviet Union manufactured an anthrax vaccine using live

attenuated (weakened) anthrax spores. This type of vaccine is not available in the West.

Although the efficacy of the live, attenuated spore vaccine has been reported to be higher

than protective antigen based vaccines, see Hedlund, op. cit., 64. See also, Meryl Nass, 

“Anthrax Vaccine,” New Vaccines and New Vaccine Technology, 13, No. 1, March 1999,

187-208. Nass writes that an obvious concern related to using this type of vaccine is that 

the live spores, although weakened, could still cause anthrax. See Inglesby, op. cit., 1740. 

39. In addition to AVA, there have been a number of experimental anti-anthrax

vaccines developed but not necessarily tested or released for use in humans. All antianthrax vaccines developed in some way center on provoking an immunogenic
The Anthrax Vaccine Debate . . . 55 

response to PA. See Hedlund, op. cit., 64-68. 

40. Ibid., 67, 76. 

41. Arthur M. Friedlander, Phillip R. Pittman, and Gerald W. Parker, “Anthrax

Vaccine: Evidence for Safety and Efficacy Against Inhalation Anthrax,” Journal of the 

American Medical Association 282, no. 22, 8 Dec, 1999, 2104-2106. 

42. In large doses and with repeated exposure formaldehyde may cause cancer. But

there is no evidence that repeated doses of trace amounts of formaldehyde when used as a

preservative in vaccines is harmful. 

43. “Anthrax Vaccine – Ingredients,” n.p.; on-line, internet, 11 February 2000,

available from http://www.anthrax.osd.mil/. 

44. “Accusations – Squalene,” n.p.; on-line internet, 11 February 2000, available

from http://www.anthrax.osd.mil/oldavip/qna/SQUALENE.HTM.

45. Squalene actually occurs naturally in humans and is a precursor in the synthesis 

of cholesterol. Squalene is also found in large amounts in deep-sea shark liver. There are

currently several health food supplemental products on the market containing squalene.

Proponents claim squalene improves the delivery of oxygen to cells and facilitates the 

clearance of metabolic toxins. For more information see http://www.takari.com/

prima.html and http://www.squalene.net/history.htm. A study reported by Asa et al. 

claims to have found that squalene antibodies are only found in the blood of people

suffering from Gulf War Syndrome. This claim forms the basis of several press reports 

in the mainstream media accusing that the Department of Defense secretly added

squalene to AVA. (Pamala B. Asa, Yon Cao, Robert F. Garry, “Antibodies to Squalene 

in Gulf War Syndrome,” Experimental and Molecular Pathology 68, no. 1 (February 

2000), 55-64.) It is very important to note that this study is poorly constructed and has 

been refuted due to insufficient numbers of subjects in the study population and lack of

sufficient control groups. In addition, the authors themselves caution in the article that 

the results of their study do not establish that squalene was used in AVA or any other

vaccine during the Persian Gulf War. 

46. Meryl Nass, “Anthrax Vaccine Safety and Efficacy: Response to the Army

Surgeon General Ronald Blanck’s Posting,” (4 May, 1998), n.p.; on-line, internet, 15

February 2000, available from http://www.dallasnw.quik.com/cyberella/Anthrax/

safety4.html. 

47. Karen Jowers, “Unusual Compound Detected in Samples of Anthrax Vaccine,”

Air Force Times, 61, Issue 11, 9 October 2000, 28. 

48. “Information About the Anthrax Vaccine and the Anthrax Vaccine

Immunization Program (AVIP),” 15 October 2000; on-line, Internet, 2 November 2000,
56 . . . The Anthrax Vaccine Debate 

available from http://www.anthrax.osd.mil/HTML interface/default.html. 

49. A study reported by Asa, et. al., claims to have found that squalene antibodies

are only found in the blood of people suffering from Gulf War Syndrome. This claim

forms the basis of several press reports in the mainstream media accusing that the

Department of Defense secretly added squalene to Anthrax Vaccine, Adsorbed. See

Pamala B. Asa, Yon Cao, Robert F. Garry, “Antibodies to Squalene in Gulf War 

Syndrome,” Experimental and Molecular Pathology, 68, no. 1, February 2000, 55-64. It

is very important to note that this study is poorly constructed and has been refuted due to

insufficient numbers of subject in the study population and lack of sufficient control

groups. In addition, the authors themselves caution in the article that the results of their 

study do not establish that squalene was used in Anthrax Vaccine, Adsorbed or any other 

vaccine during the Persian Gulf War. 

50. Meryl Nass, “Anthrax Vaccine Safety and Efficacy: Response to the Army

Surgeon General Ronald Blanck’s Posting,” 4 May 1998; on-line, internet, 15 February

2000, available from http://www.dallasnw.quik.com/syberella/Anthrax/safety4.html. 

51. The first anthrax vaccine was produced in the 1800s by Louis Pasteur for use in

animals. It was the first vaccine ever developed to protect against bacterial infection,

making anthrax the first disease for which a vaccine was ever produced. Anthrax is

probably the most studied and scrutinized of any bacterial infectious disease process. 

“Anthrax Vaccine Immunization Program,” on-line, internet, 11 February 2000, available

from http://www.anthrax.osd.mil/. 

52. PS Brachman, et al., “Field Evaluation of a Human Anthrax Vaccine,”

American Journal of Public Health, 62, 1962, 632-645. 

53. Federal Register, 50, No. 240, 13 December, 1985, Part II, 51002-51117; online, internet. Available from http://www.anthrax.osd.mil/oldavip/FedReg1.htm. See

also, Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against Inhalation 

Anthrax,” 2104. See also, Meryl Nass, “Anthrax Vaccine,” New Vaccines and New

Vaccine Technology, 13 no. 1, March 1999, 187-208. 

54.“Anthrax Vaccine – Overview,” on-line, internet, 11 Feb 2000, available from

http://www.anthrax.osd.mil/oldavip/qna/OVERVIEW.HTM. 

55. Friedlander, op. cit., 2104. 

56. Myers, op. cit.

57. Ibid. 

58. “Anthrax Vaccine, Adsorbed Stockpile Analysis – Supplemental Testing 

Needed and/or Resolvable FDA Issues,” 13 November 1998, n.p.: on-line Internet, 15

February 2000, available from http://www.anthraxvaccine.org/suppdocs/doc14.htm. 
The Anthrax Vaccine Debate . . . 57 

59. Myers, op. cit.

60. Department of Defense Press Release: 14 December, 1999; on-line internet, 11

February 2000, available from http://www.bioport.com/release12-14-99.htm.

61. Fuad El-Hibri, CEO of BioPort Corporation, Statement Presented to the 

Subcommittee on National Security, Veterans Affairs, and International Relations, 30 

June 1999; on-line, internet, 11 February 2000, available from http://www.bioport 

corp.com/El-HibriOral_Test_6-30.htm.

62. Department of Defense Press Release: 14 December, 1999. 

63. Rudi Williams, “Short Supply Forces Anthrax Vaccination Slowdown,” 

American Forces Press Service, 12 July 2000; on-line, internet, 26 August 2000, 

available from http://www.defenselink.mil/news/Jul2000/n07122000_20007124.html. 

64. Myer, op. cit.

65. Department of Defense Release, 14 December 1999. 

66. Ibid. 

67. “Accusations – Squalene,” op. cit. 

68. “Department of Defense Information About the Anthrax Vaccine and the

Anthrax Vaccine Immunization Program (AVIP),” 23 June 2000; on-line, internet, 26 

August 2000, available from http://www.anthrax.osd.mil/Site_Files/Ed_products/ 

Infopaper/Infopaper.htm. 

69. William S. Cohen, “Anthrax Vaccination Slowdown,” 10 July, 2000; on-line,

internet, 26 August 2000, available from http://www.anthrax.osd.mil/Site_Files/

AVIPslowdown/video_text.htm.

70. Todd Silver, “Federal Vaccine Manufacture Weighed: Pending Shortage of

Anthrax Preparation Finds Congress Dissatisfied with the Status Quo,” U.S. Medicine,

36, No. 8, August 2000, 47, 49-50.

71. Brachman, “Field Evaluation of a Human Anthrax Vaccine,” op. cit. 

72. Nass, “Anthrax Vaccine,” op. cit., 189. 

73. Myers, op. cit.

74. Ibid. 

75. Federal Register, op. cit.
58 . . . The Anthrax Vaccine Debate 

76. Susan S. Ellenberg, Director, Division of Biostatistics and Epidemiology,

Center for Biologics Evaluation and Research, Food and Drug Administration, Statement

to Subcommittee on National Security, Veterans Affairs, and International Relations, 21

July 1999; on-line, internet, 19 February 2000, available from http://www.hhs.gov/

progorg/asl/testify/t990721b.html. 

77. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” op. cit., 2104. 

78. “Anthrax Vaccine – Safety.” (no date); on-line, internet, 11 February 2000,

available from http://www.anthrax.osd.mil/oldavip/qna/SAFETY.HTM. 

79. “Anthrax Vaccine Adsorbed,” Food and Drug Administration Required Product

Insert; on-line, internet, 11 February 2000, available from http://bioportcorp.com/ 

AnthraxIns.htm. See also, Myers, n.p. 

80. Phillip S. Brachman, “Inhalation Anthrax,” a public domain document

originally published in Annals of the New York Academy of Sciences, 353, no date, 83-93.

81. F. Marc LaForce, “Anthrax,” Clinical Infectious Diseases, 19 December 1994, 

1009-1014. See also, “Vaccine Safety,” no date; on-line, internet, 4 September 2000, 

available from http://www.anthrax.osd.mil/Site_Files/safety/safety_info.htm. See also,

Hedlund, op. cit., 72-73. 

82. Federal Register. See also, Lew, op. cit., 1886. See also, LaForce, op. cit., 

1010. 

83. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” op. cit., 2105-2106. 

84. The Food and Drug Administration has not approved Anthrax Vaccine,

Adsorbed for use to protect against inhalation anthrax. But, lack of Food and Drug

Administration approval for a specific indication does not prohibit the use of a 

medication for that indication if clinical evidence exists to support it. Food and Drug

Administration licensure means that the medical product may be sold commercially in the 

U.S. Food and Drug Administration approval means testing for that indication has been

completed according to Food and Drug Administration specifications in connection with

the licensing process. Lack of Food and Drug Administration approval only means that

the rigorous testing required by the Food and Drug Administration (paid for by the 

manufacturer) before it will grant its endorsement has not been completed. If there is 

reasonable clinical evidence to support using a medication for an indication not approved

by the Food and Drug Administration, a physician may prescribe that medication for that 

use based on the physician’s clinical judgment. Such use is also not considered 

experimental since the medication is already licensed. In a letter to the Honorable Dan 

Burton dated 26 November 1999, Melinda K. Plaisier, the Associate Commissioner for
The Anthrax Vaccine Debate . . . 59 

Legislation for the Food and Drug Administration, discusses the procedures by which lots

are released by the Food and Drug Administration for sale and distribution. Regarding

indications for use, she states, “The labeling for Anthrax Vaccine Adsorbed does not 

mention route of exposure (e.g., cutaneous) per se. Use of the vaccine for protection 

against both cutaneous and inhalation anthrax exposure is not inconsistent with the 

labeling for Anthrax Vaccine Adsorbed.” She adds that there is no reason for Anthrax 

Vaccine, Adsorbed to be returned to an investigational new drug status when used to 

vaccinate against inhalation anthrax, especially since the rarity and risk of human 

inhalation anthrax precludes gathering additional clinical data. 

85. Myers, op. cit. See also, “Medical Readiness: Issues Concerning the Anthrax 

Vaccine,” Government Accounting Office Testimony before the Subcommittee on 

National Security, Veterans Affairs, and International Relations, 21 July 1999, 

Government Accounting Office /T-NSIAD-99-226, 7-9.

86. “Anthrax Vaccine Adsorbed,” Food and Drug Administration Required Product

Insert. 

87. “Anthrax Vaccine – Safety,” on-line, internet, 11 February 2000, available from

http://www.anthrax.osd.mil/oldavip/qna/SAFETY.HTM. 

88. Agency Group 09, “Surgeon General Testifies on Anthrax Vaccine,” FDCH

Regulatory Intelligence Database, 3 November 1999. 

89. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” 2104. See also, “Anthrax Vaccine Adsorbed,” Food and Drug 

Administration Required Product Insert. 

90. Ibid. 

91. Ellenberg, op. cit. 

92. Federal Register, op. cit.

93. “Anthrax Vaccine – Safety,” op. cit. See also, Mazzuchi, et al, op. cit., 261. 

94. Friedlander, op. cit., 2105. See also, Mazzuchi, et al, op. cit., 261. 

95. Ibid. 

96. “Medical Readiness: Safety and Efficacy of the Anthrax Vaccine,” Government

Accounting Office Testimony before The Subcommittee on National Security, Veterans

Affairs, and International Relations, 29 April 1999, GAO/T-NSIAD-99-148, 4-5. 

97. Ibid., 4. 
60 . . . The Anthrax Vaccine Debate 

98. “Anaphylaxis in Relation to Anthrax Vaccination: Analysis by Anthrax Vaccine

Immunization Program Agency,” (2 December 1999), n.p.: on-line, internet, 12 August

2000, available from http://www.anthrax.osd.mil/SCANNED/ARTICLES/grabedocs/ 

anaphylaxis.htm.

99. Inglesby, op. cit., 1735-1736, 1740, 1744. 

100. “Anthrax Vaccine – Safety,” op. cit. 

101. “Form, Vaccine Adverse Events Reporting System-1 Reports,” 23 August

2000; on-line, internet, 26 August 2000, available from http://www.anthrax.osd.mil/

HTML_interface/ \default.html. 

102. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” op. cit., 2105. 

103. “Surveillance for Adverse Events Associated with Anthrax Vaccination – U.S.

Department of Defense, 1998-2000,” Morbidity and Mortality Weekly Report 49, No. 16,

28 April 2000, 341-345; on-line, internet, 12 August 2000, available from

http://www.cdc.gov/epo/mmwr/preview/mmwrhtml/mm4916a1.htm. 

104. “Safety Review of Anthrax Vaccine, 24 April 2000,” n.p.: on-line, Internet, 12

August 2000, available from http://www.anthrax.osd.mil/SCANNED/ARTICLES/ 

grabedocs/safetyReview-Anthrax Vaccine, Adsorbed.htm.

105. Charles L. Cragin, Acting Secretary of Defense for Reserve Affairs, “The

Anthrax Vaccine: Safe, Effective, and Necessary,” Defense Link, August 1999; on-line, 

internet 11 February 2000, available from http://www.defenselink.mil/news/ 

Aug1999?n08171999_9908176.html. See also Myers, op. cit. 

106. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” op. cit., 2105. 

107. “Safety Review of Anthrax Vaccine, 24 April 2000,” op. cit. 

108. Myers, op. cit.

109. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” 2104, 2106. 

110. Jamie McIntyre, “All U.S. Troops to get Anthrax Vaccine,” CNN Interactive, 

15 December 1997; on-line, internet, 17 February 2000, available from 

http://cnn.com?U.S./9712/15/military.anthrax/. See also, Cragin, op. cit., and Mazzuchi,

et al., op. cit., 261. 

111. Inglesby, op. cit., 1735. See also, MMWR, 28 April 2000, and Friedlander,
The Anthrax Vaccine Debate . . . 61 

“Anthrax Vaccine: Evidence for Safety and Efficacy Against Inhalation Anthrax,” op. 

cit., 2104. 

112. Peter Bergen, et al., “Terror Network Eyeing U.S. Outposts Worldwide,

Officials Say,” CNN, 17 June 1999; on-line, internet, 17 February 2000, available from 

http://cnn.com/U.S./9906/17/bin.laden.threat/. 

113. David Ensor, “Panel: U.S. Not Prepared to Combat Weapons of Mass

Destruction,” CNN, 8 July 1999; on-line, internet, 17 February 2000, available from

http://cnn.com/U.S./9907/08/us.threat.study/. 

114. House, A Bill to suspend further implementation of the Department of Defense

Anthrax Vaccination Program until the vaccine is determined to be safe and effective and 

to provide for a full study by the National Institutes of Health of that vaccine, 106th 

Cong., 1st session, 1999, H.R. 2548; on-line, internet, 14 February 2000, available from

http://www.dallasnw.quik.com/cyberella/Anthrax/HR_2548.html. 

115. Hedlund, op. cit., 48. 

116. Laura Laughlin, “Shot to Hell,” Phoenixnewtimes.com, 27 January 2000; online, internet, 14 February 2000, available from http://www.phoenixnewtimes.com/issues/

2000-01-27/feature.html. 

117. Clement, op. cit., 70-71. 

118. Al Hinman, “Scientists: U.S. Must Prepare for Biological Warfare,” CNN

Interactive, 11 March 1998; on-line, internet, 17 February 2000, available from

http://cnn.com/HEALTH/9803/11/bioterrorism/index.html. 

119. Clement, op. cit., 93. 

120. Hedlund, op. cit., 76. 

121. “Anthrax Vaccine Links and Information,” on-line, internet, 27 August 2000,

available from http://www.dallasnw.quik.com/cyberella/index.htm. 

122. Thomas L. Rempfer, “Why Am I Resisting the Vaccine? The Military Trained 

Me To,” Washingtonpost.com, 30 January, 2000; on-line, internet, 5 February 2000, 

available from http://www.washingtonpost.com/wp-srv/Wplate/2000-01/30/1531-

013000-idx.html. See also, “Anthrax Vaccine Protestors Gather Outside Air Force 

Base,” Miami Herald, 29 January 2000; on-line, internet, 5 February 2000, available 

from http://www.herald.com/content/today/digdocs/026528.htm. 

123. Lieutenant General (retired) James Terry Scott, “In Defending Its Troop 

Against Anthrax, The Pentagon Has Injected Distrust Instead,” Washingtonpost.com, 30

January 2000; on-line, internet, 5 February 2000, available from
62 . . . The Anthrax Vaccine Debate 

http://www.washingtonpost.com/wp-srv/Wplate/2000-01-30-1511-013000.idx.html. 

124. “Anthrax Vaccine Immunization Program,” (no date); on-line, internet, 11

February 2000, available from http://www.anthrax.osd.mil/. 

125. Kathryn C. Zoon, letter, 28 April 1998; on-line, internet, 4 September 2000, 

available from http://www.dallasnw.quik.com/cyberella/Anthrax/Zoon4_98.html. 

126. John Davidson, “Anti bio-weapon vaccine for troops fails safety tests,”

Independent, 6 December 1999; on-line, internet, 2 September 2000, available from

http://www.dallasnw.quik.com/cyberella/Anthrax/UKHealth.html. 

127. Ibid. 

128. Several independent nationally renowned scientific groups have addressed this

issue and have found no evidence to link anthrax vaccine with illnesses among Gulf War 

veterans. There have been several unsubstantiated allegations in the media and elsewhere 

about experimental vaccines that may have contained non-Food and Drug 

Administration-licensed substances such as squalene. Only the Food and Drug

Administration-licensed anthrax vaccines have been used. See “Anthrax Vaccine and the 

Persian Gulf War,” on-line, internet, 15 February 2000, available at

http://www.anthrax.osd.mil/oldavip/qna/GULFWAR.HTM. 

129. “Anthrax Vaccine Links and Information,” op. cit.

130. “Memorandum of Understanding Between the Food and Drug Administration

and the Department of Defense Concerning Investigational Use of Drugs, Antibiotics,

and Medical Devices by the Department of Defense,” 1 May 1987; on-line, internet, 4

September 2000, available from http://www.dallasnw.quik.com/cyberella/Anthrax/

MOU.html. 

131. Laughlin, op. cit. 

132. “Food and Drug Administration Inspection Cites Problems in Anthrax Vaccine

Production,” Associated Press, 15 December 1999; on-line, internet, 14 February 2000, 

available from http.../AppLogic+FTContentServer?section=archieve&pagename=

story&storyid=115019020857. 

133. “Anthrax Vaccine Links and Information.” 

134. Those opposed to the use of Anthrax Vaccine, Adsorbed and the Anthrax 

Vaccine Immunization Program are likely to point out that the Defense Department 

information web sites, promoting the safety and efficacy of Anthrax Vaccine, Adsorbed, 

are also biased. The influence of bias in any presentation of opinion regarding Anthrax

Vaccine, Adsorbed and the Anthrax Vaccine Immunization Program makes it even more 

essential to base decisions regarding vaccination policy on documented facts. 
The Anthrax Vaccine Debate . . . 63 

135. Laughlin, op. cit. 

136. “Anthrax Vaccine Home Page,” (no date), n.p.; on-line, internet, 11 February

2000, available at http://www.anthraxvaccine.org/. 

137. “Dr. Meryl Nass,” (no date), n.p.; on-line, internet, 27 August 2000, available 

at http://www.dallasnw.quik.com/cyberella/Anthrax/credentials.html. 

138. Laughlin. 

139. Nass, “Anthrax Vaccine,” 187-208. 

140. Ibid., 199. 

141. Ibid., 203. 

142. Meryl Nass, “Adverse Effects: Anthrax Vaccine,” on-line, internet, 27 August

2000, available from http://www.anthraxvaccine.org/adveffcts.htm. 

143. “Medical Readiness: Safety and Efficacy of the Anthrax Vaccine,” op. cit., 3-

4. 

144. It is important to remember that General Accounting Office (GAO) testimonies 

are intended to present the results of fact-finding inquiries. Those conducting the 

investigations for the GAO may not be experts in the topic being investigated. The GAO 

official giving testimony appears before Congress to enter the facts resulting from the 

investigation into the record without any editorializing, comments, or conclusions. As in

any legal proceeding, the facts entered during the GAO testimony may not be all the 

facts. The GAO testimonies should be balanced and cross-examined with additional facts 

and testimony from witnesses and experts before any decisions or conclusions are 

reached. The “Anthrax Vaccine Links and Information” site and Dr. Nass tend to take

portions of GAO testimony and draw conclusions without considering statements entered

into the Congressional record by other witnesses, placing facts entered during GAO

testimonies into context. 

145. Nass, “Adverse Effects: Anthrax Vaccine,” op. cit. 

146. Ellenberg, op. cit. 

147. Gina Terracciano, Robert Chen, Jenifer Lloyd, “Surveillance for Adverse 

Events Following Vaccination,” September 1997; on-line, Internet, 15 February 2000, 

available from http://www.cdc.gov/nip/vacsafe/vaccinesafety/publications/aesurveillance. 

htm.

148. Ellenberg, op. cit. 
64 . . . The Anthrax Vaccine Debate 

149. Nass, “Adverse Effects: Anthrax Vaccine,” op. cit. 

150. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” op. cit., 2105. 

151. Lieutenant General Hal M. Hornberg, “Vaccine is Safe, Effective,” Air Force

Times, 60, Issue 16, 22 November 1999, 55. 

152. Anthrax Vaccine, Adsorbed has been administered to thousands of veterinary

and laboratory workers, livestock handlers since 1970. In addition, there have been at

least four major independent reviews by civilian panels on the safety and efficacy of 

Anthrax Vaccine, Absorbed. See “Vaccine Safety,” no-date, on-line, internet, 4 

September 2000, available from http://www.anthrax.osd.mil/Site_Files/safety/ 

safety_info.htm. 

153. It should be noted that the strength of clinical evidence would be enhanced if

more data were published in the peer-reviewed literature, and researchers should be 

encouraged to submit their data to the peer-review process. (“An Assessment of the

Safety of the Anthrax Vaccine: A Letter Report.”) 

154. Ibid. 

155. Nass, “Anthrax Vaccine,” op. cit., 203. See also, Nass, “Anthrax Vaccine

Safety and Efficacy: Response to the Army Surgeon General Ronald Blanck’s Posting,”

op. cit. 

156. Ken Alibek, Biohazard, (New York, NY: Random House, 1999), 261,281. 

See also, Inglesby, op. cit., 1744. 

157. Dr. Nass cites a study in which different strains of anthrax were tested in

guinea pigs vaccinated with Anthrax Vaccine, Adsorbed. In the study, 9 of 27 strains

appeared to be resistant to vaccination. See Nass, “Anthrax Vaccine Safety and Efficacy: 

Response to the Army Surgeon General Ronald Blanck’s Posting,” op. cit. Friedlander, 

“Anthrax Vaccine: Evidence for Safety and Efficacy Against Inhalation Anthrax,” 

however, provides a thorough review of several animal studies, including the study cited 

by Dr. Nass, in which Anthrax Vaccine, Adsorbed is tested against various strains of 

anthrax in several different animal species. He demonstrates that, while Anthrax 

Vaccine, Adsorbed provided variable protection against certain strains of anthrax in

guinea pigs, Anthrax Vaccine, Adsorbed provided excellent protection against even the 

most virulent and seemingly resistant strains (such as the Ames strain) in non-human

primates and rabbits, even after just two doses of the vaccine. This most likely reflects 

species-specific differences with the guinea pig’s immune system, making it more 

difficult to immunize the guinea pig against anthrax compared to other animal species, 

and is not due to any strain of anthrax developing resistance to the anthrax vaccine. 

(Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against Inhalation 
The Anthrax Vaccine Debate . . . 65 

Anthrax,” op. cit., 2105-2106.)

158. Nass, “Anthrax Vaccine,” op. cit., 189. See also, Inglesby, op. cit., 1744. 

159. New anthrax vaccines have been developed and are ready for clinical testing.

But so far, lack of funding has prevented the performance of clinical trial studies. 

(LaForce, op. cit., 1013.)

160. Laughlin, op. cit. 

161. Ibid., 1735. See also, Clement, op. cit., 53-54, 79. 

162. Nass, “Anthrax Vaccine,” op. cit., 204. See also, Inglesby, op. cit., 1735. 

163. Havrilak, op. cit. 

164. Hedlund, op. cit., 76. 

165. “Anthrax Vaccine Casualties at One Military Installation,” no date; on-line,

internet, 2 September 2000, available from http://www.dallasnw.quik.com/cyberella/

Anthrax/dover4-1.html. 

166. Friedlander, “Anthrax Vaccine: Evidence for Safety and Efficacy Against

Inhalation Anthrax,” op. cit., 2104. 

167. Dr. Nass reports the results of a survey sent out to members of the 9th Airlift

Squadron at Dover Air Force Base. In this report, she admits that the survey results 

cannot be used to establish that Anthrax Vaccine, Adsorbed actually caused the 

symptoms due to the lack of a control group. Overall, 252 surveys were sent out, and 139 

were completed and returned. She interprets 81 as probably having a systemic reaction

due to Anthrax Vaccine, Adsorbed. At least six indicated they felt Anthrax Vaccine,

Adsorbed did not cause their symptoms. Even though she admits there can be no

statistical analysis of this data and it is not possible to prove causality, Dr. Nass 

concludes something must be wrong at Dover because it is just not normal for so many

otherwise healthy people at one location to be having symptoms or strange illnesses of

one sort or another. A useful analysis would be to compare the rate of occurrence of

symptoms and diseases in 9th Airlift Squadron personnel against the rate of occurrence in

all unvaccinated personnel at Dover and the U.S. population in general, but this is not 

provided. Nor is there an attempt to look for recurring patterns of symptoms. Indeed, it

appears from the survey results that the patterns of symptoms vary widely, with no two

individuals’ symptom patterns matching. (Meryl Nass, “Survey Results of the 9th Airlift 

Squadron,“ op. cit., no date; on-line, internet, 27 August 2000, available from

http://www.anthraxvaccine.org.) 

168. Lieutenant General Paul K. Carlton, Jr., “Anthrax,” no date; on-line, internet, 4

September 2000, available from http://sg-www.satx.disa.mil/af/sg/presentations/
66 . . . The Anthrax Vaccine Debate 

Anthrax_Threat.ppt. 

169. H.R.2548. See also, Mike Ahlers, “Congressional Panel Recommends

Suspension of Military’s Anthrax Vaccine,” CNN, 17 February 2000; on-line, internet, 17 

February 2000, available from http://cnn.com. 

170. Scott, op. cit. 

171. Ibid. 

172. Ibid. 

173. “An Assessment of the Safety of the Anthrax Vaccine: A Letter Report,” op

cit. 

174. The letter, dated 30 March 2000, is the result of a request the Secretary of

Defense sent to the Institute of Medicine to assess the safety of Anthrax Vaccine,

Adsorbed. The Institute of Medicine commented that its assessment is an early step in 

sorting out the complex issues surrounding Anthrax Vaccine, Adsorbed and has started a 

two-year in-depth study that will include a review of all available data from the 

Department of Defense. (“A Letter Report from the Institute of Medicine (IOM), 30 

March 2000,” no date; on-line, internet, 12 August 2000, available from

http://www.anthrax.osd.mil/SCANNED/ARTICLES/ltrReportINtro.htm.) 

175. Inglesby, op. cit., 1740. 
The Anthrax Vaccine Debate . . . 67 

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provide education and research to the present and future leaders of the 

USAF, to assist them in their activities to counter the threats posed by 

adversaries equipped with weapons of mass destruction 

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68 . . . The Anthrax Vaccine Debate