Assistant Secretary of Defense for Health Affairs William Winkenwerder issued policy guidance today that reiterates and strengthens long-standing DoD policy to avoid immunization of servicewomen of childbearing age during pregnancy.
This action was taken because of issues raised about preliminary data from a non-peer reviewed Naval Health Research Center Study of women who received the anthrax vaccine.
"Although these study results are preliminary and there are significant concerns about the database that require further investigation before any conclusions can be made, we are taking these steps to reaffirm our existing policies," stated Winkenwerder.
The preliminary data, which has not been scientifically peer reviewed and will require further validation, identified a possible relationship between maternal anthrax vaccination in the first trimester and higher odds of birth defects. Because the data supporting the study showed that a number of women might have received the anthrax vaccine beyond the first trimester, study data is now being re-validated. The peer-review publication process usually takes several months. The final report will be available then.
At the Department's request, the Centers for Disease Control and Prevention will issue a report next week in its Morbidity and Mortality Report that provides further details of the study. Winkenwerder's memo is on the Web at http://www.defenselink.mil/news/Jan2002/d20020116inoc.pdf .