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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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