HHS Press
Release
Released: 12.18.01
STATEMENT BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
Additional Options for Preventive Treatment For Those Exposed to Inhalational
Anthrax
Many of those who were exposed to inhalational anthrax in the recent mail
attacks are presently concluding their 60-day course of preventive
antibiotic treatment. Some of these persons, especially those who may have
been exposed to very high levels of anthrax spores, may wish to take
additional precautions. The Department of Health and Human Services (HHS)
is providing two additional options beyond the 60-day antibiotic course,
for those who may wish to pursue them: an extended course of antibiotics,
and investigational post-exposure treatment with anthrax vaccine.
HHS will make anthrax vaccine available to those who were exposed to
inhalational anthrax, who have concluded their antibiotic treatment and
who wish to receive the vaccine as an investigational product. The vaccine
is being made available in this investigational mode, under an
investigational new drug application (IND) at the option of the
individual, in recognition of the limited nature of the data now available
concerning inhalation anthrax treatment and the factors underlying
development of the disease, as well as uncertainty concerning the extent
of exposure to spores that some persons may have received in the recent
anthrax incidents. The decision to use this vaccine is at the discretion
of the individual, in consultation with his or her physician.
Background
Existing data, based especially on animal models, indicate that
inhalational anthrax is unlikely to occur after 60 days following
exposure. This is the basis of the recommendation for 60 days treatment
with an effective antibiotic. So far, no known cases have developed in
individuals who were recently exposed to inhalation anthrax and who were
prescribed the 60-day antibiotic course. HHS health agencies continue to
recommend that those who were prescribed the 60-day antibiotic course and
who conclude this course of treatment, or who stopped taking the medicine
prior to 60 days, should remain watchful of their health and be in close
communication with a physician who is aware of their exposure status. A
number of individuals have already concluded the 60-day course, or have
stopped taking the antibiotics prior to the 60-day conclusion, and no
cases have been reported among them.
At the same time, other animal data indicate that live spores may
continue to reside in the lungs beyond the 60-day period, even though
these animals did not develop disease. Traces of live spores have been
detected in the lungs up to 100 days following exposure. This raises the
theoretical possibility that the spores remaining in the lung area might
still, after 60 days, result in anthrax.
If such a late infection were to occur, HHS scientists believe that the
infection could be successfully treated, as were cases of inhalation
anthrax that were identified early during the anthrax mail attacks. At the
same time, HHS recognizes that some individuals may wish to take extra
precautions, especially those whose exposure may have been especially
high.
Options
There are three options for individuals exposed to inhalational anthrax:
Current Recommendation -- 60 days of antibiotic treatment, accompanied
by careful monitoring for illness.
Additional Option 1 -- 40 additional days of antibiotic treatment -- This
course would be intended to provide protection against the theoretical
possibility that spores might cause infection up to 100 days after
exposure. It should be accompanied by monitoring for illness or adverse
reactions.
Additional Option 2 -- 40 additional days of antibiotic treatment, plus
anthrax vaccine as an investigational treatment -- In addition to the 40
days of additional protection, this option would involve three doses of
anthrax vaccine over a four-week period, to provide immunity to infection
over a longer period of time. This is not currently an FDA-approved use of
the vaccine, however the vaccine may provide additional protection by
inducing an immune response to the anthrax organism. As an investigational
new drug, the vaccine would need to be administered with the full informed
consent of the individual as to possible risks. Individuals would also be
asked to take part in a follow-up study measuring the effect of the
vaccine when administered after exposure.
All those who are concluding a 60-day course of antibiotic treatment
should monitor their health and be in close contact with their physician.
Those who may wish to continue taking antibiotics for an additional 40
days should consult their physician about this course. Those who may wish
to take part in the investigational post-exposure use of the anthrax
vaccine should consult their physician or a physician at the site where
vaccine is being administered.
Contact: HHS Press Office
(202) 690-6343
