Antimicrobics and Infectious Disease Newsletter (Elsevier Science) 2000;
Controversy over Safety and Efficacy
Garth L. Nicolson, Meryl
Nass and Nancy L. Nicolson
In 1999 2.4 million U.S.
Armed Forces personnel, including more than one million reserve and National
Guard members, were ordered to receive anthrax vaccine over a period of
several years. This was justified to counter an increasing threat from
hostile countries and possibly terrorist groups that now or in the future
will likely possess the capability of fielding weaponized anthrax spores as
a Biological Weapon (BW). This decision has resulted in courts-martial and
disciplinary hearings among U.S. Armed Forces personnel who have refused the
anthrax vaccine on safety grounds. Are these individuals overreacting to
misperceived risks from the anthrax vaccine that the military considers
safe, or are there real safety concerns that should be considered?
as a BW Agent
anthracis is a relatively common spore-forming soil
bacterium found rarely in the U.S. but more commonly in some areas of the
world as an endogenous infectious agent.
Bacillus anthracis infection can
cause death within six days of exposure to a lethal dose, usually by
inhalation of spores. To be effective as a BW agent a microorganism must be
highly infectious, very pathogenic and stable in the air and environment for
the period of time needed for dissemination and infection of large numbers
of people. Spore-forming bacteria like
Bacillus anthracis are ideal for this purpose. Spores are
relatively inactive metabolically and are much more resistant to sunlight,
heat, dryness and chemicals than the replicating microorganism.
Weaponized versions of anthrax spores are more pathogenic and survive
better than spores from native strains of
Bacillus anthracis. It is
estimated that as few as 50,000 weaponized anthrax spores can kill a human
after inhalation and fewer can kill small primates.
anthrax spores are probably the most easily manufactured BW weapon, they are
only one of dozens of lethal and incapacitating (causing nonlethal
sicknesses) BW agents that have been produced in large quantities suitable
for BW deployment and tactical use.
Bacillus anthracis is also one of the few BW agents for which a
vaccine exists that is capable of preventing some (but not all) lethal
infections. Although dozens of additional microbial candidates for BW have
been produced in various quantities by several countries, such as bacteria (Clostridium
Clostridium perfringens, Bacillus cereus,
Coxiella burnetii, among others), toxins (ricin, aflatoxin,
Staphylococcal enterotoxin B
toxin, tricothecene mycotoxins, etc.), viruses (Ebola, West Nile fever,
Marburg, small pox, etc.) and miscellaneous BW (rickettsias, mycoplasmas,
fungi, etc.), weaponized Bacillus
anthracis is considered one of the greatest threats because of
the ease of its production, storage and dissemination (spores) as a lethal
There are basically
three methods to counter anthrax BW: active immunization, passive
immunization and prophylactic antibiotics. Antibiotics have to be
administered shortly before or after exposure, otherwise they wont be
effective, and they cannot prevent a lethal infection once the
Bacillus anthracis has produced
signs of illness. Passive immunoprophylaxis requires quantities of immune
sera or monoclonal antibodies not currently available, and their
administration in a monitored, hospital setting. Active immunity using
vaccines on the other hand can be administered years before exposure as long
as immunity is maintained. Thus vaccines can be effective as long as there
is enough immunity to neutralize the
Bacillus anthracis before it starts rapidly replicating
en masse from its inactive spore
form and producing lethal toxins. From a practical standpoint, only
antibiotics and vaccines can protect the large numbers of people who could
be exposed in a BW attack, and antibiotics are more effective when the BW
agent(s) and its(their) antibiotic sensitivity are identified so the
appropriate antibiotic(s) can be used.
vaccines then a reliable method of protecting against
Bacillus anthracis BW? Not
necessarily. Although vaccines can protect against accidental exposure of
relatively small doses of anthrax spores that infect skin wounds, such as
encountered occasionally in meat processing, it remains unproven whether
anthrax vaccines will actually protect against a lethal aerosol dose of
inhaled anthrax spores of the weaponized variety that are used as BW
agents. This is especially true if mixtures of BW agents are used instead
of single BW agents.
The Anthrax Vaccine: Safety
The anthrax vaccine in use remains
unproven in its ability to stop a lethal dose of weaponized
Bacillus anthracis spores, and
there are questions about its safety. According to the U.S. Army Medical
Research Institute for Infectious Disease (USAMRIID) at Fort Detrick, MD,
the anthrax vaccine used by the military was determined to be safe, and
adverse reactions were found to occur only at the rate of one per 50,000
doses (less than 0.002%). This has now been revised to a rate of 0.02-0.2%
or higher. Moreover, in recent testimony by one of us [M.N.] to the
National Academy of Sciences the safety of the anthrax vaccine and the rates
of adverse reactions were questioned. Using Dover AFB as an example, the
rate of chronic health problems after receiving the anthrax vaccine may be
as high as 7%. The difference is that the official rates are for acute
reactions only. The Department of Defense (DoD) claims that the rate for
vaccine chronic reactions is zero.
A major part of the problem in
assessing vaccine safety is in how vaccine adverse effects are reported.
Many people who suffer from adverse anthrax vaccine effects are reluctant to
step forward to seek medical care, because they have seen their colleagues'
concerns dismissed as due to depression or stress. They also fear that they
could lose their ability to perform their duties, as a number of the pilots
and airmen at Dover AFB are now on DNIF (duties not including flying) status
because of undiagnosed illnesses that began after they received their
anthrax vaccinations. Lt. Colonel Randy Randolf, director of the U.S.
Armys vaccination program, counters that all vaccines, the anthrax vaccine
included, can produce adverse effects, such as soreness, redness, itching,
swelling, and lumps at the injection site. He has stated that about 30% of
men and 60% of women report these local reactions, but they usually last
only a short time. Lt. Col. Randolf further describes that beyond the
injection site, from 5% up to 35% of people have noticed muscle aches, joint
aches, headaches, rash, chills, fever, nausea, loss of appetite, malaise, or
related symptoms. It is commonly thought that these symptoms go away after
a few days, and apparently there have been no completed studies of the
long-term side effects of anthrax vaccine using active surveillance.
Although the DoD began such a study at Tripler Army Medical Center, Honolulu
in September, 1998, they have yet to release any preliminary data on
long-term problems that developed after anthrax vaccination.
The difference between what military
and civilian physicians conclude about adverse reactions and the anthrax
vaccine seems to be based on whether you accept that vaccines can cause
chronic illnesses beyond the initial reporting period of vaccine adverse
effects. The high incidence of unusual chronic health problems at Dover AFB
include systemic signs and symptoms, such as vomiting, diarrhea,
polyarthralgias, fever, splenic tenderness, cognitive problems, polymyalgias,
weakness and numbness, and these problems can occur well after the usual
reporting period for vaccine adverse effects. Patients with preexisting
autoimmune illnesses such as rheumatoid arthritis, lupus, multiple
sclerosis, among others, are probably more likely to suffer a serious
adverse reaction, as are those with neurologic disease, such as those who
had polio in childhood. Stevens Johnson Syndrome, a severe allergic reaction
in which there is loss of epidermis (skin) and the lining of the GI tract,
was found in some patients as well as more classic allergic signs and
symptoms. Even more serious, many anthrax vaccine recipients report
seizures with complete loss of consciousness. Respiratory distress and a
variety of pulmonary illnesses have also been reported. Because these types
of reactions have rarely been identified with other vaccines and because few
of those reporting illness have been subjected to an exhaustive medical
evaluation, including sophisticated immunological testing, the mechanisms by
which anthrax vaccine may be causing illnesses have not been elucidated.
Furthermore, the entire stockpile of anthrax vaccine is owned by the DoD,
and none has yet been made available for thorough, independent testing.
The Anthrax Vaccine: Source
One of the most
difficult problems in dealing with anthrax vaccine safety is obtaining
specific information on the anthrax vaccine and how it was determined to be
safe. Most military vaccines in the U.S. are from sole-source
manufacturers. In the case of FDA-approved vaccines, a number of strict
production and safety requirements must be fulfilled, and evidence for
effectiveness in humans must be presented to the FDA before approval for
production and sale is granted. However, in the case of the anthrax vaccine
there seem to be missing elements in this safety net.
The sole producer
of the anthrax vaccine was originally Michigan Biologic
Products, Inc., a state-owned corporation that obtained U.S. Government
approval for the anthrax vaccine at a time when FDA approval was not
required. The anthrax vaccine was approved by the Bureau of Biologics at
NIH in 1970, two years before efficacy data and approval were required by
the FDA. In the case of the anthrax vaccine, long-term safety data were not
supplied with the license application, and none has yet been supplied to the
FDA. As it turns out, the
Bacillus anthracis vaccine now being produced
may be different or the procedure for vaccine preparation modified from the
original vaccine approved by NIH. The usual requirement is that any new
product or modification in preparation must be examined and approved by the
FDA, but the FDA has apparently not examined or approved every modification
made to the current vaccine for anthrax.
original license and the facility producing the anthrax vaccine was owned by
Michigan Biologic Products, Inc. of the Michigan State Department of
Health. The new owner of both is a company called Bioport, Inc., owned by a
group of investors lead by Admiral William Crowe, Jr., former head of the
Joint Chiefs of Staff, DoD, and Faud El-Hibri, a German citizen of Lebanese
descent who has since obtained American citizenship. The facility was sold
to Admiral Crowes investor group after the DoD decided to vaccinate all of
its servicemen and servicewomen against anthrax. Recently Bioport ran into
financial problems and negotiated a series of changes in its DoD contract
that increases by three-fold the per dose price of the anthrax vaccine
supplied to the military. This and other problems have resulted in a
congressional investigation into the financial relationship between DoD and
the new owners of Bioport, which may constitute a conflict of interest.
The Anthrax Vaccine: Safety
Problems with the
anthrax vaccine have raised questions about previous vaccine programs. The
former commander of the USAMRIID, Dr. Phillip Russell, admitted in an
infectious disease journal (Infectious
Disease Clinics of North America, 1990) that unlicensed anthrax
vaccines were used on Armed Forces personnel before the Gulf War. There is,
of course, no record of safety available for unlicensed vaccines. In fact,
there were no published studies of safety or efficacy
for the current anthrax vaccine until very recently, well after the decision
was made to vaccinate. A recent brief publication from the USAMRIID
in JAMA provides some safety
information about the anthrax vaccine, but it refers to previously
unpublished data that are not available for evaluation.
procedure for post-marketing vaccine evaluation requires that the FDA must
review adverse vaccine reactions collected through the Vaccine Adverse Event
Reporting System (VAERS). Adverse events are usually recorded independently
by a FDA-approved contractor. The contractor then sends its data to the
FDA, and the FDA assembles a committee that then evaluates adverse events
for the likelihood that the vaccine might have caused them, and it can
recommend further study. However, in the case of the anthrax vaccine,
military physicians were instructed that only certain adverse effects could
be vaccine reactions, such as classic immediate allergic reactions, and
others, such as joint pain, cognitive disturbances, etc. could not be due to
the vaccine. Physicians treating these patients had no access to published
data on anthrax vaccine side effects, and there is no entry for anthrax
vaccine in the Physicians Desk Reference (PDR). The package insert for the
vaccine is based on data collected from an earlier anthrax vaccine, and it
does not list the range of possible reactions that could occur. Thus until
recently none of the long-term chronic effects of the vaccine were even
reported by medical providers. In the case of the anthrax vaccine, only
reactions that resulted in hospitalization or immediate loss of 24 hours of
duty time were reported to a military clearing-house for vaccine reactions.
This has changed recently, and it appears now that other adverse vaccine
effects will be entered in the medical records of patients, but whether they
are always reported to the FDA remains questionable. We feel strongly that
traditional and accepted means of FDA vaccine evaluation must be implemented
for military vaccines, just as they are required for commercial vaccines.
Only then can the safety of the anthrax vaccine be evaluated. The anthrax
vaccine should be treated just like any other commercial vaccine and not
given special waivers or treatment in the evaluation process. Only then
will the public be satisfied that the current anthrax vaccine is safe.
The Anthrax Vaccine: Quality
Michigan Biologic Products Inc. had been warned by the
FDA of intent to revoke their license to produce vaccines because of
violations in the production and testing of their vaccines. As recently as
1997, MBPI received formal written notification from the FDA that they had
not complied with FDA-mandated requirements. However, since MBPI was the
only manufacturer of anthrax vaccine, they were given a waiver and allowed
to remain open, pending FDA compliance. During this time vaccine lots were
distributed to the military. In 1998 some of these vaccine lots were
retested, and only 6 out of 31 lots passed initial supplemental testing.
Most of the retested vaccine lots had expired or had been redated for an
additional 3-year period once or even twice. This is obviously
question has been raised whether expired or failed vaccine lots were used
for vaccinating military personnel during the Gulf War. Since supplemental
testing on anthrax vaccines used in the Gulf War was not undertaken, and
some of these lots apparently also had previously expired and had been
redated, some personnel could have received out-of-date vaccines, or worse,
contaminated vaccines. Information is not available on whether U.S. Forces
received contaminated vaccines (no such testing has been made public), but
the British Gulf War veterans report that several vaccine lots from the Gulf
War were reported to be contaminated with unknown microorganisms. Thus
some of the health problems associated with the anthrax vaccine could be
related to possible vaccine contamination.
the Gulf War
Before military personnel were deployed to the Persian Gulf Theater of
Operations, they had to pass physical examinations and be fit for active
duty. After passing their physical exams, they received several types of
vaccinations, mostly with commercially available vaccines. In the Persian
Gulf area this was usually done by administering as many as two dozen
vaccine doses over a period of a few days, even if the vaccines were
normally required to be given over a course of several months to over a
year. In contrast to previous wars, service personnel were not allowed to
keep a record of these vaccinations, and according to the DoD the shot
records of hundreds of thousands of deployed personnel have since
disappeared. Some health personnel administering the vaccines were also
warned that they would be courts-martialed if they kept any record of
vaccines given to military personnel. According to nurses that took part in
the vaccination program, many soldiers became sick after the vaccines were
given, but few were allowed to report the adverse effects of the vaccines,
unless they were hospitalized. Most had to return to active duty, even if
they suffered adverse effects directly attributable to the vaccines. The
records of these adverse effects are for the most part also missing.
The problem with administering multiple
vaccines all at once is that this can result in immune-depression and leave
individuals susceptible to opportunistic infections, such as the types that
the vaccines were supposed to protect against. To be effective, the
vaccines used in the Gulf War should have been given in several steps, the
initial vaccination followed by several boosters given over months to over a
year to maximize immunity. If given all at once, these vaccines are more
likely to cause adverse reactions and produce diminished immunity; thus they
may be useless in protecting an individual, and they may even make the
vaccinated person more susceptible to opportunistic infections due to
Illnesses and Vaccines
100,000-200,000 veterans of the Persian Gulf War in 1991 now have Gulf War
Illnesses (GWI), which are characterized by complex, multi-organ chronic
signs and symptoms. These include chronic fatigue, headaches cognitive
problems, nausea, gastrointestinal problems, vomiting, diarrhea,
polyarthralgias, fever, splenic tenderness, polymyalgias, among other signs
and symptoms. Often these patients show the appearance of rheumatic and
other autoimmune signs and symptoms. The signs and symptoms of GWI overlap
with Chronic Fatigue Syndrome (CFS) or Myalgic Encephalomyelitis (ME), and
often they meet the criteria for the diagnosis of CFS/ME or Fibromyalgia
syndrome (FMS) where the distinguishing feature is the presence of chronic
fatigue and widespread muscle pain and tenderness. Often included in this
complex clinical picture are increased sensitivities to various
environmental agents and enhanced allergic responses. There are other
clinical problems in these patients, including impaired cardiac function,
increases in spontaneous abortions and other chronic signs. The signs and
symptoms reported by many anthrax vaccine recipients also overlap with GWI.
In some cases GWI
has spread to immediate family members. Although incomplete, a 1994 report
by investigators of a U.S. Senate committee found after contacting
approximately 1,200 GWI families that ~77% of spouses and ~65% of children
born after the war developed the chronic signs and symptoms of GWI.
Although officially denied by the
U.S. DoD and British Ministry of Defence,
this indicates that at least a subset of GWI patients have an illness that
is being passed to spouses and children. Since some of the GWI patients
have an illness that is transmissible to family members and perhaps others
as well, these GWI cases cannot be explained solely on the basis of chemical
or radiological exposures, or the even more unlikely cause of battlefield
stress leading to Post Traumatic Stress Disorder.
Although stress can
induce some illness, the General Accounting Office (GAO), the
investigational arm of the U.S. Congress, after studying government and
civilian data on GWI, concluded that the link between stress and GWI was not
established. Of course, stress can exacerbate chronic illness but most
military personnel indicated to us that the Gulf War was not a particularly
stressful war, and they strongly doubted that stress was the origin of their
illnesses. However, in the absence of physical or laboratory tests that
could identify possible origins of GWI, many physicians accepted that stress
was the cause of GWI or that it was caused by combinations of chemical
exposure and stress. A recent psychiatric study indicates that patients
with GWI do not fit the classical picture of stress related illness.
stress is added to multiple vaccines given at once, plus chemical and other
toxic exposures encountered during the Gulf War, then immune suppression and
opportunistic infections could be a likely outcome in at least a subset of
the military personnel that subsequently came down with GWI. This would
also explain in some cases the apparent transmission of illness to immediate
family members and the occurrence of GWI in some vaccinated forces that were
Contamination and Gulf War Illnesses
Testing of commercial vaccine lots demonstrates that contamination can and
does occur. A common vaccine contaminant is
Mycoplasma species of the class
Mollicutes, small cell wall-deficient bacteria lacking many of the genes
involved in macromolecular and lipid synthesis. Although not widely
appreciated for their ability to cause disease, mycoplasmas have been
implicated in a variety of chronic illnesses, including CFS/ME, FMS,
Rheumatoid Arthritis and GWI. When we examined thousands of GWI patients
for evidence of blood mycoplasmal infections, we found evidence of
mycoplasmas in about one-half of GWI cases, and in particular, one species
of mycoplasma, Mycoplasma fermentans,
was found at high incidence. M.
fermentans has been examined over the last decade or so by the
Armed Forces Institute of Pathology for its role in causing a progressive,
non-HIV AIDS-like fatal disease that has many of the hallmarks of GWI.
Mycoplasmas like M. fermentans
could be involved in the transmission of GWI to immediate family members.
When symptomatic family members of veterans with GWI were tested for the
presence of mycoplasmal infections in their blood, they were found to have
the same species of mycoplasma as found in the sick veteran family member.
In addition, most of these patients responded to the appropriate antibiotics
and eventually recovered, albeit slowly, from their illness, similar to what
we have seen in CFS/ME, FMS and Rheumatoid Arthritis patients with
mycoplasmal infections. When recovered patients were retested for
mycoplasmal blood infections, they were no longer positive for
Mycoplasma species in their
blood samples. This suggests that mycoplasmal infections could be causing
at least some if not most of the signs and symptoms of GWI found in these
patients, and these infections can be passed to family members who then
develop similar illnesses.
remains to be determined is whether the vaccines used in the Gulf War were
the source of the mycoplasmas found in veterans blood. A study reporting
the presence of antibodies to an unlicensed vaccine adjuvant in over 90% of
the GWI patients evaluated has just been published. This strongly suggests
that experimental vaccines were used in the Gulf War. Experimental vaccines
are unapproved vaccines without available safety and efficacy data.
Although listed as our number one possible source of the infections found in
GWI patients, vaccines are not the only possible source of microorganisms
from the Gulf War. In our sworn testimony to the U.S. Congress [G.L.N.,
N.L.N.] we stated that there were several
potential sources of chronic biological agents in the Gulf War. The Iraqis
were known to have extensive stockpiles of BW agents and the potential to
deliver these weapons offensively, at short range in modified Italian-made
biological sprayers that deliver BW agents onto the sand to create
exclusionary zones or 'biological minefields' and at long range in modified
SCUD-B (SS-1) missiles with 'airburst' warheads or sprayers carried by
aircraft. Many of the storage and factory facilities where BW agents were
stored were destroyed immediately up to, during and after the Desert Storm
ground offensive, releasing plumes containing these agents high in the
atmosphere where they could be carried downwind ('blow-back' exposures) to
our lines. These and other possible mechanisms of potential exposure must
be carefully examined as well as the possible role of mycoplasmas and other
chronic infections in GWI patients.
War, Terrorism and BW Attacks
If BW agents are
ever deployed in war or terrorist attacks, many times the lethal (human)
dose could be encountered in an aerosolized BW and chemical mixture that is
designed to inhibit and overwhelm the bodys defensive abilities. These
mixtures, called Russian Doll Cocktails, contain microorganisms plus
immune inhibitors and other chemicals to impede the immune systems ability
to contain the infection by blocking pulmonary defenses. The pulmonary
immune system, particularly the pulmonary macrophage, is the first level of
defense against inhaled foreign microorganisms and its suppression could
result in systemic infection. BW use on the battlefield of the future will
likely involve multiple BW
agents, not just one or even a few agents. Countries like Iraq operate
under Soviet War Doctrine, a battle strategy that stresses combinations of
conventional and unconventional weapons. Thus combinations of multiple BW,
CW (Chemical Warfare) or even NW (Nuclear Warfare) agents may be used
together to heighten BW virulence and confuse the diagnosis and treatment of
casualties. The rationale is to overwhelm a medical corps ability to
effectively manage large numbers of casualties with unknown or incomplete
diagnoses. Iraqi Field Manuals found during the Gulf War described this
strategy in detail. Unfortunately, BW can be developed and produced at a
fraction of the cost of other weapons of mass destruction, making it likely
that future terrorists will choose BW agents over other weapons for
The U.S. militarys
strategy of defense against BW agents is prior immunization using multiple
vaccines. Unfortunately, this can only be successful if the exact BW agents
likely to be encountered are known in great detail and for some time in
advance of exposure. For example, the vaccine against
Bacillus anthracis requires a
rather lengthy immunization protocol, administering multiple vaccine and
booster doses over more than a year. If multiple vaccines were to be
administered, then they would have to be administered at different times to
prevent immune suppression or excessive stimulation. Obviously, this
strategy requires advance knowledge of the threat and careful long-term
preparation against the threat. To prepare for any new threat that arises
will require some time, possibly years or over a decade. Recent reports
have appeared indicating that the Russians have developed anthrax strains
for which it is claimed protective vaccines do not exist. What is the
evidence that our multivalent Bacillus
anthracis vaccine will protect against all known anthrax
Protection against BW Attacks
besides the vaccine approach to BW defense are available. During the Gulf
War the French forces elected not to use vaccines as a primary defense
against Iraqi BW and not to use anti-nerve agents as a defense against Iraqi
Chemical Warfare agents. Instead, they used prophylactic antibiotics to
counter Iraqi BW agents, and they depended on protective suits to counter
Iraqi chemicals. Interestingly, the French Armed Forces were the
only nation in the Coalition
Forces that did not report any cases of GWI, nor were there any illnesses
reported in the immediate families of French Gulf War veterans.
What assurances do
we have that future vaccines will be free of microbial contamination that
could cause disease? Obviously, the purity and safety of vaccines depend on
their ability to remain free of contamination by microorganisms.
FDA-mandated vaccine preparation methods are generally considered adequate
to prevent this possibility, but unless each batch or lot of vaccine is
routinely tested for possible contamination, including animal testing, this
remains a possibility that must be carefully examined, not uncritically
dismissed by untrained bureaucrats as a remote hypothetical possibility.
antibiotic or antiviral agents are used for BW defense, can these be
defeated? Yes, BW agents can be modified or constructed that have
integrated into their genomes antibiotic- or antiviral-resistance genes.
Similar to the engineering of more lethal BW agents to circumvent known
vaccines, such microorganisms can be engineered to resist specific
antibiotic or antiviral agents. Interestingly, certain U.S. units were
issued antibiotics like ciprofloxacin and doxycycline just before the ground
offensive in the Gulf War. These antibiotics would be expected to be
effective in preventing infections of at least two of the agents identified
in veterans with Gulf War Illness
(Mycoplasma fermentans and
Examination of the numbers, deployments and types of casualties and their
diagnoses in the units administered antibiotics before and during the Gulf
War could tell us if the French approach to BW defense was more or less
effective than our approach of administering multiple vaccines to prevent BW
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