Pertagen 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.
Up until now, pertussis-containing vaccines were only available as combination vaccines (Tdap). Pregnant women reported pain at the injection site significantly less frequently after vaccination with Pertagen than after combined Tdap_chem vaccines (see Adverse Reactions).
Pertagen can be used as a standalone pertussis vaccine to vaccinate pregnant women against pertussis during the second or third trimester of pregnancy in accordance with WHO and local recommendations.
Safety data of Pertagen and Td-Pertagen (Pertagen combined to tetanus and diphtheria toxoids) given either in the second or third trimester are available from three randomized controlled trials (250 pregnancies), one observational study (497 pregnancy outcomes), an active post-marketing surveillance study (3,924 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 Pertagen harms the fetus at any trimester of pregnancy.
Lactation: No study on lactation was performed. However, as Pertagen contains inactivated antigens, 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).