Adacel Polio Use In Pregnancy & Lactation

Pregnant Women: Safety: No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women.
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-POLIO or ADACEL (Tdap component of ADACEL-POLIO; containing the same amounts of diphtheria, tetanus and pertussis antigens) during the 2^nd or 3^rd 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-POLIO during any trimester would harm the fetus.
Limited data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born to women vaccinated with ADACEL-POLIO during pregnancy. The clinical relevance of this observation is unknown.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
The benefits versus the risks of administering ADACEL-POLIO during pregnancy should be evaluated.
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.