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Notice to Readers: Status of U.S. Department of Defense
Preliminary Evaluation of the Association of Anthrax Vaccination and
Congenital Anomalies
The U.S. Department of Defense (DoD), Center for Deployment Health Research at Naval Health Research Center,
San Diego, used computerized medical records to conduct a preliminary evaluation of the potential association between the use
of anthrax vaccine in the first trimester of pregnancy and the diagnosis of congenital anomalies in children. Review
of preliminary data indicated important limitations in computerized medical records that preclude drawing conclusions
from this preliminary study. Investigators are conducting a systematic evaluation of original medical records, including
vaccination and infant health records. This evaluation will require several months.
Although the Food and Drug Administration-licensed vaccine has not been suspected to be a hazard to reproductive
health, no studies of animals or pregnant women have been conducted, and the vaccine is neither recommended nor licensed for
use in pregnancy. DoD continues to maintain a policy of avoiding anthrax vaccination of pregnant women. Because of
the importance of protecting women of childbearing age from adverse health events, both military and civilian
health-care
providers should continue to ask women if they are pregnant or intend to become pregnant and should not vaccinate
women who state that they are pregnant.
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