Pregnancy & Lactation : הריון/הנקה

4.6 Fertility, pregnancy and lactation

Pregnancy
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), 2 prospective observational studies (2670 pregnancy outcomes), 4 retrospective observational studies (81,701 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 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-POLIO during any trimester would harm the fetus. The benefits versus the risks of administering ADACEL-POLIO 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-POLIO 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.
Breastfeeding
The effect of administration of ADACEL-POLIO during lactation has not been assessed. Nevertheless, as ADACEL-POLIO contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. The benefits versus the risk of administering ADACEL-POLIO to breastfeeding women should be evaluated by the health-care providers.

Fertility
ADACEL-POLIO has not been evaluated in fertility studies.