ANTHRAX VACCINE -- ELIGIBILITY CRITERIA

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ANTHRAX VACCINE -- ELIGIBILITY CRITERIA

1. Who should not take the anthrax vaccine?

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.

2. Why won't the DoD give anthrax vaccine to people younger than 18 years or

older than 65 years?

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 has

chosen to abide by the age ranges in the FDA-approved labeling for its

anthrax vaccine immunization program.

3. Why aren't HIV-positive or immunodeficient people included in DoD's

anthrax vaccine immunization program?

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.

For More Information:

Advisory Committee on Immunization Practices. General recommendations on

immunization. MMWR-Morbidity & Mortality Weekly Report 1994;43(RR-1):1-38.

ftp://ftp.cdc.gov/pub/Publications/mmwr/rr/rr4301.pdf.