Anthrax Vaccine May Increase Incidence Of Birth Defects For Pregnant Women

Wall Street Journal
January 16, 2002

By Laura Johannes, Staff Reporter of The Wall Street Journal

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 post-exposure 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.