Anthrax vaccine may cause birth defect Navy study prompts CDC warning to postal workers, Capitol Hill

http://www.detnews.com/2002/health/0201/17/a04-392873.htm
By Deborah Funk / Army Times 1/2002

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.