RE: ANTHRAX AND BOTULINUM TOXOID VACCINES
Before U.S. troops deployed to the Gulf region, they received a standard series
of inoculations against infectious diseases-e.g., cholera, typhoid, tetanus,
diphtheria, polio, and measles-that might be given to any U.S. citizen
traveling to these regions. After arriving in the Gulf War region, some U.S.
service members received two additional vaccines for protection against the BW
agents anthrax and botulinum toxin.
In 1970, FDA licensed anthrax vaccine to protect civilian
workers against possible infection by anthrax bacteria. Since 1967 and before
the Gulf War, more than 20,000 inoculations had been routinely administered to
at-risk populations, including laboratory personnel who work with the bacteria
that causes anthrax, persons in industries that work with animal hides and wool
(which can be a source of anthrax infection), and veterinarians who come in
contact with anthrax-infected animals.
Although active long-term safety surveillance is not generally part of the FDA
vaccine licensing process, the FDA encourages U.S. health care providers and
the law requires manufacturers to report serious adverse reactions for all
licensed vaccines.305 FDA has not received data that raise concerns about the
safety of the anthrax vaccine.
Historical data for short-term health effects of the anthrax vaccine
indicate up to six percent of recipients experience mild discomfort,
including tenderness, redness, swelling or itching at the inoculation site for
up to 72 hours. Fewer than one percent experience a more severe local reaction
that potentially limits the use of the arm for one to two days. Systemic
reactions, e.g., fever, malaise, are uncommon (about 0.1 percent).102,103
According to DOD, medical monitoring and surveillance conducted during the Gulf
War found the expected short-term side effects of anthrax vaccines occurring at
approximately the historical rates.53 A single hospitalization for a
vaccination site infection was reported. DOD points out that precise
information about all possible short-term side effects is unknown, however,
because of difficulties in collecting such data during and after the Gulf
Botulinum toxoid (BT) vaccine has been used for
more than 25 years to protect industry and laboratory workers from
occupational exposure to the extremely poisonous botulinum toxins. All civilian
vaccinations have been administered under an investigational new drug (IND)
application sponsored by CDC. For both civilian and military use, BT vaccine
remains in "investigational" status-i.e., not yet licensed by FDA.
Since 1970, as part of the IND evaluation, FDA has reviewed information from
CDC about the cumulative safety record for BT vaccine. Records of more than
10,000 administered vaccine doses (including approximately 2,200 in the five
years before the Gulf War) indicate that treated individuals experience only
local side effects often associated with many types of vaccinations. These
effects, primarily at the injection site, include local pain, tenderness,
swelling, redness, and itching. Systemic reactions such as temporary fever,
tiredness, headache, or muscle pain also can occur. Rarely, reactions include
soreness of the arm sufficient to leave individuals unable to perform duties
for a day or two or development of a lump at the injection site that generally
resolves within several weeks. Such adverse reactions also are observed with
other licensed toxoid vaccines, such as diphtheria and tetanus toxoids.53,102
The U.S. Army examined the frequency of side effects of BT vaccinations seen in
some U.S. service members. In one report of 237 Gulf War veterans who had
received BT vaccine, 2.5 percent had systemic reactions. This rate parallels
that recorded by the U.S. Army and CDC prior to the Gulf War.127
The Committee examined the hypothesis that
Gulf War veterans' illnesses could be the result of contamination of anthrax
vaccine lots by Mycoplasma incognitus.182 Discussions with staff of FDA, Walter
Reed Army Medical Center, U.S. Army Medical Research and Materiel Command,
academic experts, and the manufacturer of the vaccines indicate that Mycoplasma
could not survive in the anthrax and BT vaccines.136,138,168,303 Mycoplasma is
difficult to grow, and the culture media used to produce Anthrax and BT
vaccines do not contain serum, an essential ingredient for Mycoplasma growth.
In addition, the vaccines are preserved and/or processed with other products
that create a hostile
environment for Mycoplasma, including:
- formaldehyde (anthrax and BT vaccines),
- benzethonium chloride (anthrax vaccine only),
- isotonic saline solution (BT vaccine only), and
- Thimerosal (BT vaccine only).
The Committee concludes it is unlikely that Mycoplasma organisms
contaminated anthrax vaccine or BT vaccine.
The human immune system has evolved the capability to deal with thousands of
foreign substances, to sort them out, and to regulate immune response. Humans
live among a vast population of
hostile microorganisms, and vaccinations-even multiple, contemporaneous
vaccinations-are a small part of total immune stimulation. Individual vaccines
can cause adverse effects, but several studies of the effects of giving
multiple vaccinations at one time have found no adverse effects associated with
the practice. Research on this issue continues, but based on available
evidence, the Committee believes it is unlikely that multiple vaccines are
responsible for illnesses reported today by Gulf War
What do we conclude about the risks of vaccines to Gulf War veterans?
The Committee concludes it is unlikely that health effects reported by Gulf War
veterans today are the result of exposures to the BT or anthrax vaccines, used
alone or in combination.
join the discussion .
analyzing the major theories .
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the veterans .
a closer look .
examining the media's role .
a guide to the site .
comparing gulf veterans' health with other veterans .
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