Boostrix Use In Pregnancy & Lactation

Fertility: No human data available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility.
Pregnancy: Boostrix can be used between 27 and 36 weeks 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) where Boostrix was administered to pregnant women between 27 and 36 weeks of pregnancy have have shown no vaccine related adverse effect on pregnancy or on the health of the foetus/newborn child (see Adverse Reactions).
Safety data from prospective clinical studies on the use of Boostrix during the first and second trimester of pregnancy are not available.
Additional safety data obtained from a prospective observational study with Boostrix (793 pregnancy outcomes) and from post-marketing surveillance with Boostrix and Boostrix Polio, where pregnant women were vaccinated during the third trimester in a period that partially overlaps with the weeks of pregnancy from the randomized controlled clinical trial (i.e. between 27 and 36 weeks), 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 vaccination with Boostrix 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 when administered to breast-feeding women has not been evaluated.
It is unknown whether Boostrix is excreted in human breast milk.
Boostrix should only be used during breast-feeding when the possible advantages outweigh the potential risks.