Boostrix Use In Pregnancy & Lactation

Pregnancy: Boostrix 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 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 or Boostrix Polio during the first and second trimester of pregnancy are not available.
Data from passive surveillance where pregnant women were exposed to Boostrix or to Boostrix Polio (dTpa-IPV vaccine) in the 3rd or 2nd 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 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 (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breastfeeding: The effect of administration of Boostrix during lactation has not been assessed. Nevertheless, as Boostrix contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. The benefits versus the risk of administering Boostrix to breastfeeding women should carefully be evaluated by the health-care providers.
Fertility: No human data from prospective clinical studies are available. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).