Boostagen Use In Pregnancy & Lactation

Pregnancy: Pertussis vaccination during pregnancy reduces the risk of pertussis in young infants. This results from direct passive protection by active transplacental transfer of pertussis antibodies to the fetus during pregnancy. Vaccination is recommended during each pregnancy, including pregnancies that are closely spaced.
Safety data of Boostagen given either in the second or third trimester are available from three randomized controlled trials (250 pregnancies), one observational study (252 pregnancy outcomes), an active post-marketing surveillance study (1,499 pregnant women) and ongoing post-marketing passive surveillance (see Adverse Reactions).
Safety data from clinical trials have shown no vaccine related adverse effect on pregnancy or on the health of the fetus/newborn.
As with other inactivated vaccines, it is not expected that vaccination with Boostagen harms the fetus at any trimester of pregnancy.
Lactation: No study on lactation was performed. However, as Boostagen contains inactivated antigens and toxoids, no risk to the breastfed infant should be expected.
Fertility: No human data on fertility is available. Animal studies do not indicate direct or indirect adverse effects on female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).