Boostrix Polio Use In Pregnancy & Lactation

Fertility: No human data available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see Toxicology: Pre-clinical Safety Data under Actions).
Pregnancy: Boostrix Polio can be used during the second or third trimester of pregnancy in accordance with official recommendations.
For data relating to the prevention of pertussis disease in infants born to women vaccinated during pregnancy, see Pharmacology: Pharmacodynamics under Actions).
Safety data from a randomised controlled clinical trial (341 pregnancy outcomes) and from a prospective observational study (793 pregnancy outcomes) where Boostrix (dTpa component of Boostrix Polio) was administered to pregnant women during the third trimester have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child.
Safety data from prospective clinical studies on the use of Boostrix Polio or Boostrix during the first and second trimester of pregnancy are not available.
Data from post-marketing surveillance where pregnant women were exposed to Boostrix Polio or to Boostrix in the second or the third trimester have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child.
As with other inactivated vaccines, it is not expected that Boostrix Polio harms the foetus at any trimester of pregnancy.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or post-natal development.
Lactation: The safety of Boostrix Polio when administered to breast-feeding women has not been evaluated.
It is unknown whether Boostrix Polio is excreted in human breast milk.
Boostrix Polio should only be used during breast-feeding when the possible advantages outweigh the potential risks.