Adacel/Adacel Polio Use In Pregnancy & Lactation

Adacel: Pregnancy: 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 same amounts of tetanus, diphtheria and pertussis antigens as ADACEL) during the second or third 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 Pharmacology: Pharmacodynamics under Actions.
Breast-feeding: It is not known whether the active substances included in ADACEL are excreted in human milk but antibodies to the vaccine antigens have been found to be transferred to the suckling offspring of rabbits. Two animal developmental studies conducted in rabbits have not shown any harmful effects of maternal antibodies induced by the vaccine on offspring postnatal development.
However, the effect on breast-fed infants of the administration of ADACEL to their mothers has not been studied. As ADACEL is inactivated, any risk to the infant is unlikely. The risks and benefits of vaccination should be assessed before making the decision to immunize a nursing woman.
Fertility: ADACEL has not been evaluated in fertility studies.
Adacel Polio: Pregnant Women: The effect of ADACEL-POLIO on the development of the embryo and fetus has not been assessed. Limited post-marketing data is available following administration of ADACEL-POLIO in pregnant women. Vaccination in pregnancy is not recommended unless there is a definite risk of acquiring pertussis. As the vaccine is inactivated, risk to the embryo or the fetus is improbable. The benefits versus the risks of administering ADACEL-POLIO during pregnancy should be carefully evaluated when there is a high probable risk of exposure to a household contact or during an outbreak in the community.
Nursing Women: The effect of administration of ADACEL-POLIO during lactation has not been assessed. As ADACEL-POLIO is inactivated, any risk to the mother or the infant is improbable. However, the effect on breast-fed infants of the administration of ADACEL-POLIO 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.