Adacel Use In Pregnancy & Lactation

Pregnant Women: Safety: Adacel can be used during the second or third trimester of pregnancy in accordance with official recommendations (see DOSAGE & ADMINISTRATION).
Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 1 prospective observational study (546 pregnancy outcomes), 5 retrospective observational studies (124,810 pregnancy outcomes), and from passive surveillance of women who received ADACEL or ADACEL-POLIO (Tdap-IPV; containing the Tdap component of ADACEL) during the 2nd or 3rd trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child. As with other inactivated vaccines, it is not expected that vaccination with ADACEL during any trimester would harm the fetus.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
For information on immune responses to vaccination during pregnancy and its effectiveness at preventing pertussis in infants, see ACTIONS.
Nursing Women: The effect of administration of ADACEL during lactation has not been assessed. As ADACEL is inactivated, any risk to the mother or the infant is improbable. However, the effect on breast-fed infants of the administration of ADACEL to their mothers has not been studied. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.