CDC Warns Civilians Anthrax Vaccine May Be Linked To Birth Defects

Army Times
January 21, 2002
Pg. 22

By Deborah Funk, Times staff writer

The Centers for Disease Control and Prevention are warning civilians that
the anthrax vaccine may be linked to birth defects if given during
pregnancy, according to data from a preliminary Navy study that is still
under review.

"At this time no one knows for sure whether this vaccine can cause fetal
harm," the CDC said.

The warning is part of a new informed-consent form created by the CDC for
certain civilian postal workers and Capitol Hill staff who have been offered
the vaccine on a voluntary basis in the wake of the recent anthrax mail
attacks.

The notice is the first public acknowledgement of a potential link between
the vaccine and birth defects, and it contradicts an Army study at Fort
Stewart, Ga., 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, the rates, who was studied or
what time period the study covers. Defense officials would say only that the
Navy conducted the study.
"The report is still in draft form only and is currently undergoing
revisions," said CDC spokesman Llewyn Grant. "Itâs not yet available for
public release."

Defense officials said they would not provide details until they checked the
accuracy of the information. "Weâre trying to figure out if the numbers the
computer spit out can be relied on or not," said Army Lt. Col. John
Grabenstein, deputy director of clinical operations for the Pentagonâs
Anthrax Vaccine Immunization Program Agency.

Defense officials gave the information on the recent Navy study to the CDC
"because it was data in our possession," Grabenstein said. "We were trying
to be responsible."
Navy officials acknowledged the existence of the study, but they too would
provide no other information. In a prepared statement, the Navy Bureau of
Medicine and Surgery said:

"Initial findings from research conducted at the Naval Health Research
Center (NHRC) suggest that anthrax vaccine administered to women during
pregnancy may be associated with a higher risk of birth defects in their
infants" compared to infants of unvaccinated women and those inoculated
before and after pregnancy.

The study results "relied solely on automated data, not individual health
record review or patient interviews," and must be validated, according to
the statement.

"BUMED will expeditiously validate the data and methods upon which the
research study is based. Results will be completed as soon as possible."

Officials expect to finish validating the study by early April, said BUMED
spokesman Lt. j.g. Mike Kafka.

The statement noted that Defense Department policy defers administering
vaccines, including the anthrax vaccine, to pregnant women.

"Nonetheless, women may receive the vaccine before they know they are
pregnant," the statement went on. "Regardless of this studyâs results, DoD
is redoubling its efforts to prevent the inadvertent vaccination of pregnant
women."

Retired Air Force Col. Redmond Handy, who opposes the mandatory anthrax
inoculation program, said he has heard from many women who report that
military health-care providers ask no questions about possible pregnancies
before giving the shots.

"Thatâs abuse," said Handy, president of NOABUSE, the National Organization
of Americans Battling Unnecessary Servicemember Endangerment.

The military began vaccinating troops against anthrax more than three years
ago. Although the anthrax vaccine, like other inactivated vaccines, is
deferred during pregnancy under Pentagon policy, the Defense Departmentâs
anthrax vaccine Web site states that "if a vaccine is inadvertently given to
a pregnant woman, no adverse pregnancy outcome or fetal harm is expected
because of the vaccineâs inactive state."

Civilian postal workers and Capitol Hill staff must sign a consent form to
take the anthrax vaccine because it is being used in a different way than
approved under its license and because the vaccine batch being offered to
them is not approved by the Food and Drug Administration.

Those civilians would get the vaccine after potential exposure and would
receive only three shots. Under its license, the vaccine is given before
exposure to prevent infection and six shots are given over 18 months.

The militaryâs anthrax vaccine program has stalled because of a supply
problem as the sole maker of the vaccine, BioPort Inc., tries to win FDA
approval of its production license after completing major upgrades to its
plant. The vaccine offered to civilians was made after the renovations and
is not FDA-approved. The agency still is reviewing BioPortâs license