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

By Deborah Funk / Army Times

   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.

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