DSI Newsletter: Anthrax Vaccine

DSI Newsletters, Issue 53:
Anthrax Vaccine

Anthrax is a serious disease that can affect both animals and humans. It has been described as far back as biblical times. It is caused by bacteria called Bacillus anthracis. People get anthrax from contact with infected animals, wool (wool sorters disease), meat, or hides. In its most common form, anthrax is a skin disease that causes skin ulcers and usually fever and fatigue. Up to 20% of these cases are fatal if untreated. Anthrax produces three important syndromes. They are cutaneous anthrax, inhalation anthrax, and gastrointestinal anthrax. Any virulent strain can produce all three forms, depending on the type of exposure.
Cutaneous Anthrax occurs when anthrax spores get into tiny cuts in the skin, almost always on exposed areas of the arms, face and neck. Clinically, it begins with skin swelling and an innocent-looking pink spot about the size of a dime that may itch. Within a day or so it becomes a blister surrounded by swelling, and then a nonpainful, coal-black ulcer. Historically, the black ulcer gave rise to the name of the disease ("anthrax" comes from the Greek word for "burning coal"). In 5-30% of untreated cases, it invades the blood stream, leading to death. However, antibiotic treatment is curative in all cases. We see an average of about one case per year in the U.S.
Inhalation Anthrax occurs when large numbers of anthrax spores in particles that are just the right size are inhaled into the tiny air sacks (alveoli) of the lungs. Exposed patients are unaware of inhaling the spores. One to six days after exposure (but sometimes up to 60 days), the early stage begins with a mild flu-like illness with low grade fever, muscle aches, cough and mild chest pain (note that stuffy nose is not involved in early anthrax infection). After a day or two, these mild symptoms improve for 3-5 days. Then the final stage begins suddenly with high fever, severe chest pain, shock, respiratory failure and often death within 24-48 hours. Antibiotics are curative in the first two stages but do not help in the final stage. Before October 2001, only 18 cases of inhalation anthrax had been recognized in the U.S. in the Twentieth Century, none since 1978, and 16 of these were occupationally acquired by people who worked in wool factories, laboratories, etc.
Gastrointestinal Anthrax occurs when the spores are ingested in contaminated, undercooked meat. It causes high fever and abdominal pain, followed by nausea, vomiting and bloody diarrhea. Untreated, the mortality rate is up to 50%. No cases have ever been reported in the U.S.
When B. anthracis is inhaled, as when used as a biological weapon, it is a much more serious disease. The first symptoms may include a sore throat, mild fever and muscle aches. But within several days these symptoms are followed by severe breathing problems, shock, and often meningitis. Once symptoms appear, this form of anthrax is almost always fatal, despite treatment with antibiotics.
The anthrax vaccine protects against anthrax disease. The U.S. vaccine does not contain actual B. anthracis cells and it does not cause anthrax disease. Anthrax vaccine was licensed in 1970. Based on limited but convincing evidence, the vaccine protects against both cutaneous and inhalation anthrax.
The people that should get the anthrax vaccine are those 18 to 65 of age who will be potentially exposed to large amounts of B. anthracis bacteria on the job, such as laboratory workers. Military personnel who may be at risk of anthrax exposure from weapons should receive it also.
The basic vaccine series consists of six doses. The first three doses are given at two-week intervals. Three additional doses are given at: 6, 12, and 18 months after the first dose. Annual booster doses are needed for ongoing protection. If a dose is not given at the scheduled time, the series does not have to be started over. Resume the series as soon as practical. Anthrax vaccine may be given at the same time as other vaccines.
Don't give the vaccine to anyone who has had a serious allergic reaction to a previous dose of anthrax vaccine should not get another dose; or, anyone who has recovered from cutaneous anthrax. Pregnant women should not be routinely vaccinated with anthrax vaccine. This is merely a precaution. There is no evidence that the vaccine is harmful to either a pregnant woman or her unborn baby. Vaccination may be recommended for pregnant women who have been exposed, or are likely to be exposed, to anthrax. There is no reason to delay childbearing after either the man or the woman gets anthrax vaccine. Vaccines, including anthrax vaccine, are safe to give to breast-feeding women.
The anthrax vaccine does have more side effects than usual vaccines. Getting anthrax disease is much more dangerous than any risk from the vaccine, however. Like any medicine, a vaccine is capable of causing serious problems, such as severe allergic reactions. The risk of anthrax vaccine causing serious harm, or death, is extremely small. Mild side effects include: soreness, redness, or itching where the shot was given (about 1 out of 10 men, about 1 out of 6 women); a lump where the shot was given (about 1 person out of 2); muscle aches or joint aches (about 1 person out of 5); headaches (about 1 person out of 5); fatigue (about 1 out of 15 men, about 1 out of 6 women); Chills or fever (about 1 person out of 20); Nausea (about 1 person out of 20). Moderate side effects include: Large areas of redness where the shot was given (up to 1 person out of 20). Severe side effects include: Serious allergic reaction (very rare; less than once in 100,000 doses).
As with any vaccine, other severe problems have been reported. But these events appear to occur no more often among anthrax vaccine recipients than among unvaccinated people. There is no evidence that anthrax vaccine causes sterility, birth defects, or long-term health problems. Independent civilian committees have not found anthrax vaccination to be a factor in unexplained illness among Gulf War veterans.
A severe reaction to the anthrax vaccine should be looked for, including: any unusual condition, such as severe allergic reaction or high fever. If a severe allergic reaction occurred, it would happen within a few minutes to an hour after the shot. Signs of a serious allergic reaction can include difficulty breathing, weakness, hoarseness or wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of the throat. If any of these things occurred: Call a doctor, or get the person to a doctor right away; Tell your doctor what happened, the date and time it happened, and when the vaccination was given; Ask your health care provider to file a Vaccine Adverse Event Reporting System (VAERS) form if you have any reaction to the vaccine. Or call VAERS yourself at: 800-822-7967 or www.vaers.org.

Sincerely:

Joseph Saponaro, MD, DABIM, FACP, CPI, CCI, CCTI, CCRC, CCRP
Board Certified Internist, JPMC
Principal Investigator, DSI
Diplomat American Board of Internal Medicine
Fellow American College of Physicians
Certified Physician Investigator by the AAPP
Certified Clinical Investigator by the DIA
Certified Clinical Trial Investigator by the ACRP
Certified Clinical Research Coordinator by the ACRP
Certified Clinical Research Professional by SoCRA
Member: The American College of Preventive Medicine
Founder, www.CertifiedResearchers.com
Member, Jupiter Medical Center IRB
Expert Medical Witness, www.ExpertMD.MD

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