http://www.detnews.com/2002/health/0201/17/a04-392873.htm
Anthrax vaccine may
cause birth defects
Navy study prompts CDC warning to
postal workers, Capitol Hill
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WASHINGTON -- The
Centers for Disease Control and Prevention are warning civilians that the
anthrax vaccine might be linked to birth defects if taken during pregnancy,
according to a preliminary Navy study still under review.
The warning is part of a new informed-consent form from the
Centers for Disease Control and Prevention for civilian postal workers and
Capitol Hill staff offered the vaccine after anthrax mail attacks.
Workers must sign the form to take the vaccine because it is
being used in a different way -- after potential exposure as opposed to before
and in different doses -- than approved under its license, and because the Food
and Drug Administration has not approved the vaccine batch being offered.
"At this time no one knows for sure whether this vaccine
can cause fetal harm," the CDC said.
The military's anthrax-vaccine program has stalled because of
a supply problem with the sole maker of the vaccine, BioPort Inc. of Lansing.
The vaccine is from older lots produced before BioPort received FDA approval.
The FDA has informed BioPort that it will allow production to resume.
The CDC notice is the first public acknowledgement of a
potential link between the vaccine and birth defects, and it contradicts an
Army study that found no reproductive health problems related to the anthrax
vaccine for military women who received the shots.
Details of the new study are sparse. Neither the CDC nor the
Pentagon would say what types of birth defects were found, their rates, who was
studied or the time the study covers. Defense Department officials only said
that the Navy conducted the study.
"The report is still in draft form only and is currently
undergoing revisions," CDC spokesman Llewyn Grant said. "It's not yet
available for public release."
Officials expect to finish validating the study by early
April.
ALL
INFORMATION, DATA, AND MATERIAL CONTAINED, PRESENTED, OR PROVIDED HERE IS FOR
GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
KNOWLEDGE OR OPINIONS OF THE PUBLISHER, AND IS NOT TO BE CONSTRUED OR INTENDED
AS PROVIDING MEDICAL OR LEGAL ADVICE. THE DECISION WHETHER OR NOT TO
VACCINATE IS AN IMPORTANT AND COMPLEX ISSUE AND SHOULD BE MADE BY YOU, AND YOU
ALONE, IN CONSULTATION WITH YOUR HEALTH CARE PROVIDER.