| MYTH: |
Anthrax infection is just like the flu.
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| FACT: |
Although an inhalation anthrax infection does begin with symptoms that could be described as “flu-like,” the infection does not resemble the flu. The difference is that the flu symptoms, like sore throat, muscle ache, malaise and fever stay the same over a period of days. They may become more intense at times, but they never progress to the severity of an anthrax infection. In an anthrax infection, breathing problems can worsen within hours or days.
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| MYTH: |
Antibiotics are the best way to prevent anthrax infection.
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| FACT: |
Antibiotics would only prevent anthrax infection if taken for an extended period of time. However, this would cause unacceptable consequences in terms of long-term use. In fact, long-term use of antibiotics as prevention may do more harm than good by creating antibiotic resistant strains of anthrax. Vaccination is the best way to prevent anthrax infection. There is a vaccine to prevent anthrax, but it is not yet available for the general public. Anyone who may be exposed to anthrax, including certain members of the U.S. armed forces, laboratory workers, and workers who may enter or re-enter contaminated areas, may get the vaccine. Also, in the event of an attack using anthrax as a weapon, people exposed would get the vaccine. Antibiotics are best used AFTER exposure to the bacteria as a presumptive treatment. The anthrax vaccine is the only preventive measure that currently exists.
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| MYTH: |
The vaccine currently used has not been tested. |
| FACT: |
The The FDA has a strict approval process for all drugs and vaccines. Licensed for nearly thirty-five years, the vaccine has undergone rigorous testing for both safety and efficacy. All vaccines are regulated by FDA's Center for Biologics Evaluation and Research (CBER). The development of the vaccine involved extensive animal studies before approval to administer the vaccine to humans was granted. There has been one clinical trial in humans.
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| MYTH: |
The anthrax vaccine is based on outdated technology. |
| FACT: |
The anthrax vaccine has been developed over the years, starting out as an animal vaccine, and resulting in the production of a vaccine that is safe and effective for human use. The manufacturing of anthrax vaccine meets all current FDA standards for production. Although there are other vaccines under development, this does not mean that the current one is outdated. Tetanus toxoid and smallpox vaccine are based on technology older than anthrax vaccine. Age isn’t important, effectiveness is.
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| MYTH: |
The anthrax vaccine will not prevent all strains of anthrax. |
| FACT: |
The common agent in the disease process of ALL strains of anthrax is the called the protective antigen (PA). The current vaccine is directed specifically at this agent, not at a particular strain. The Institute of Medicine declared that it is unlikely that either naturally occurring or anthrax strains with bio-engineered protective antigen could evade the vaccine and cause an anthrax infection. ***LINK*** The vaccine has been proven more than 90 percent effective against inhalation anthrax through various animal studies.
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| MYTH: |
The anthrax vaccine has dangerous side effects including death. |
| FACT: |
All vaccines have side effects, including death in rare instances. However, anthrax vaccine has never been determined by medical experts to have been the cause of any death. The anthrax vaccine’s side effects are comparable to other commonly used drugs and vaccines. “Serious” events are those resulting in hospitalization, permanent disability or death. The vast majority of adverse reactions to the vaccine are local reactions. These may include tenderness, soreness and redness at the site of the injection, as well as some fever muscle aches and pains.
The government maintains a reporting system to collect information about side effects from every vaccine. The database is called the Vaccine Adverse Event Reporting System (VAERS) and accepts events that occur after the administration of U.S. licensed vaccines.
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| MYTH: |
The vaccine causes miscarriages and infertility. |
| FACT: |
There is no scientific information to support this statement. A recent study reported in the Journal of the American Medical Association followed over 4,000 military women to look at pregnancy rates and adverse birth outcomes between groups of women who had been vaccinated and women who had not. Although the study was small, it found that anthrax vaccination had no effect on pregnancy or adverse birth outcomes.
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| MYTH: | The vaccine is linked with the Gulf War Syndrome. |
| FACT: |
“Gulf War Syndrome” is a term for unexplained symptoms experienced by some veterans of the 1990-1991 Persian Gulf War. Current research has not documented any single cause of Gulf War syndrome, but existing scientific evidence does not support a link between anthrax vaccine and Gulf War Syndrome. The CDC has conducted investigations of the health concerns of Persian Gulf War veterans and examined a possible association with vaccination, including anthrax vaccination. One study conducted among air force personnel evaluated several potential risk factors for chronic multi-symptom illnesses, including anthrax vaccination. Although, the occurrence of a chronic multi-symptom condition was linked to deployment to the Persian Gulf War, it was not linked with specific exposures that happened during the war. In fact, the same symptoms also affected veterans who had not been deployed to the Persian Gulf.
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| MYTH: |
The CDC used an experimental vaccine on congressional members and postal workers. |
| FACT: |
Anytime a licensed drug is used in a way that is different from the way it obtained its license, that use is considered investigational or experimental. You may also hear it referred to as “off-label.” The anthrax vaccine is not experimental. But, it is licensed for use BEFORE exposure in a 6-dose series and the CDC offered 3 doses AFTER exposure. Anthrax vaccine was offered to congressional members and postal workers according CDC's Advisory Committee on Immunization Practices (ACIP) recommendations which were first made in 2000 and re-affirmed in 2002 following the anthrax letters. As this was not an FDA-licensed use of the vaccine, the vaccine was administered under an “investigational new drug” or experimental protocol.
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| MYTH: |
The vaccine manufacturer had their FDA license taken away. |
| FACT: |
The anthrax vaccine is only licensed for manufacture by the firm BioPort, which acquired the vaccine production facility from the Michigan Biologic Products Institute (MBPI) in September 1998. When the manufacturer voluntarily closed its facility for renovations, production of the vaccine was suspended early that year. Production resumed in 1999. However, because of changes made to the facility where the vaccine is produced and changes to the labels and package insert, the new lots of vaccine were not released for routine use until the FDA approved the license supplement for the renovations in December 2001 and gave final approval for distribution of the vaccine in January 2002, following approval of the manufacturer's filling capabilities. This is common practice for the FDA. |