Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation
Pregnancy

Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 2 prospective observational studies (2670 pregnancy outcomes), 4 retrospective observational studies (81,701 pregnancy outcomes), and from passive surveillance of women who received ADACEL or REPEVAX (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. The benefits versus the risks of administering ADACEL during pregnancy should be evaluated.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.

Limited clinical data have shown there is interference with the immune response to other antigens (i.e.
diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with ADACEL during pregnancy. However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. The clinical relevance of this observation is unknown.

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.