Anthrax Vaccine-Eligibility Criteria |
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1) Who should not take the anthrax vaccine? |
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Those with a true hypersensitivity reaction (serious allergic reaction) to a previous dose of the anthrax vaccine, people infected with HIV, people who have other kinds of immune suppression, pregnant women, and people under 18 and over 65 years of age. Other temporary reasons for deferring anthrax vaccination include an acute respiratory disease or active infection, and a temporary course of immune-suppressing drugs such as steroids (e.g., prednisone). Vaccinations should be resumed when these issues are resolved. If a person has an active infection or is taking a prescription medication that suppresses the immune system, a decision to give the anthrax vaccine will be made on a case-by-case basis. |
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2) Should people with lupus (SLE) get vaccinated? |
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People who have been diagnosed with lupus should talk with their physician about whether or not they should be vaccinated, considering the state of their disease, the medications they take, and their personal risk for specific infections. Several medical studies have shown that people with lupus can be safely and effectively vaccinated against influenza, hepatitis B, pneumococcal disease and other diseases that would pose a significant risk if they were infected. For military personnel with lupus, providers are authorized to grant medical exemptions according to the patient's specific situation. Medical specialists can advise how to get the best benefit from vaccination in such circumstances. |
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3) Why doesn’t DoD policy include giving anthrax vaccine to people younger than 18 years or older than 65 years? |
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The FDA has only licensed the anthrax vaccine for use in people between ages 18 and 65. FDA does not perform its own clinical research; it reviews the quality of research performed by others. FDA can only determine the effectiveness of a vaccine in the same kind of population as the vaccine was tested in. No formal studies of children, adolescents, or the elderly have been performed to date. Once such studies are performed, FDA can determine if sufficient evidence is available.
Individual physicians can treat individual people in ways that are outside the limitations of a package insert (these are called "off-label" uses of drugs). Indeed, DoD knows of no example of a vaccine that is effective among adults that is not also effective in the elderly or in adolescents. DoD policy is to abide by the age ranges in the FDA-approved labeling for its Anthrax Vaccine Immunization Program. |
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4) Why aren't HIV-positive or immunodeficient people included in DoD's Anthrax Vaccine Immunization Program? |
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Anthrax vaccine’s package insert says "anyone that is immunodeficient should not receive the vaccination." This precaution refers to the fact that the recipient, being immunodeficient, would be less likely to mount a full immune response to the vaccine, thus reducing the vaccine’s intended benefit. Inactivated vaccines are not considered to be harmful to immunodeficient people. HIV-positive and other immunodeficient people should receive the anthrax vaccine if exposure occurs or is imminent. These personnel should be counseled that the vaccine is not expected to harm them, but they may not mount as complete an immune response to protect against anthrax as other people do. Under these conditions, the adage "some protection is better than none" would apply. |
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5) For More Information: |
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Advisory Committee on Immunization Practices. General recommendations on immunization. MMWR-Morbidity & Mortality Weekly Report 2002;51(RR-2):1-35. http://www.cdc.gov/mmwr/pdf/rr/rr5102.pdf |
