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Last Updated

16 Dec 2002

Source: Wall Street Journal, January 16, 2002.


Anthrax Vaccine May Increase Incidence of Birth Defects for Pregnant Women


A preliminary U.S. Navy study has found that use of the anthrax vaccine in pregnant women may cause a higher incidence of birth defects.

The study, while unconfirmed, complicates the already difficult decision as to whether those potentially exposed to anthrax bacteria should get inoculated. Thousands of Capitol employees and postal workers may have been exposed to the bacteria through contaminated letters this fall.

Some physicians recommend that those individuals get vaccinated even if they have no symptoms, since the bacteria can linger in the body for months.

So far, results of the study remain under wraps. In response to questions, the Navy disclosed its findings in general terms. However, it declined to release any other information -- including basic details about how many people were in the study or how it was designed.

"I can't tell you much about it because the study's not complete yet," said Capt. Ryland Dodge, a spokesman for the Navy's medical department. Analysis of the results is expected to be completed by early April.

In a written statement, the Navy said its results suggest that the vaccine "may be associated with a higher risk of birth defects" in the infants of women who were inoculated during pregnancy.

It described the results as "initial findings," which it is in the process of validating. In recent months, the U.S. Department of Health and Human Services has been making the vaccine available to civilians who may have been exposed to anthrax. However, HHS hasn't taken a position on whether people should take it. Such postexposure vaccination is still considered experimental. In its extensive warning about possible vaccine side effects, HHS discloses that the Navy study found a possible link to birth defects. However, it adds, "At this time no one knows for sure whether this vaccine can cause fetal harm."

The anthrax vaccine, made by closely held BioPort Corp. of Lansing, Mich., has sparked protests among military personnel required to take it as a condition of service.

Some who received it claim it caused serious health problems, and more than 100 troops have faced courts-martial rather than get the vaccine.

The military has long maintained that the anthrax vaccine, given in six doses over 18 months, is safe. However, the military has a longstanding policy of not giving the vaccine to pregnant women, based on a recommendation from the Food and Drug Administration.

In recent years, the anthrax vaccine has been in short supply because of quality-control problems at BioPort.

Following the anthrax attacks, making more anthrax vaccine became a national priority, and BioPort late last month received FDA approval for a renovated factory. However, before it can distribute the vaccine, BioPort still must complete work on two quality-control tests and gain agency approval for a Spokane, Wash., facility where the vaccine is placed in vials.

BioPort had no immediate comment on the study.