19 December 2001
Text: Further Precautions Offered for Anthrax Exposure
(U.S. health officials make vaccine, more antibiotics available)
(1,100)
The U.S. Department of Health and Human Services (HHS) is offering
thousands of people who may have come into contact with anthrax
further options for treatment. The offer comes as persons who may have
been exposed to the potentially fatal disease spores are completing a
60-day course of preventive antibiotics that was initially prescribed.
In a press statement issued December 18, HHS outlined the additional
options that it is presenting to potentially exposed people, primarily
workers in a Washington D.C. postal facility and a Congressional
office building. Anthrax-laden letters, addressed to members of
Congress, moved through these buildings, releasing spores in their
path.
HHS will make further antibiotic treatment and an anthrax vaccine
available to workers who want additional protection from the possible
development of disease. The press release says that dormant spores
with the potential to release disease-causing bacteria could have
survived the initial antibiotic treatment and remain lodged in the
lungs of those exposed.
HHS is not recommending or suggesting the vaccine, but only making it
available in view of "the limited nature of the data now available
concerning inhalation anthrax treatment." The press release says, "The
decision to use this vaccine is at the discretion of the individual,
in consultation with his or her physician."
No cases of inhalational anthrax have developed in persons who have
completed or stopped the antibiotic treatment, the release says.
Authorities are still investigating the anthrax attacks. Eighteen
persons in several Eastern U.S. locations developed the disease in
either the inhalational form, or the less dangerous skin form. Five
have died from inhalational anthrax.
Following is the text of the HHS press release:
(begin text)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HHS Press Office (202) 690-6343
STATEMENT BY THE DEPARTMENT OF HEALTH AND HUMAN SERVICES
Regarding 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.
Note: All HHS press releases, fact sheets and other press materials
are available at www.hhs.gov/news.
(end text)
(Distributed by the Office of International Information Programs, U.S.
Department of State. Web site: http://usinfo.state.gov)
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