Gardasil 9 Use In Pregnancy & Lactation

Pregnancy: A large amount of data on pregnant women (more than 1000 pregnancy outcomes) indicates no malformative nor foeto/neonatal toxicity of GARDASIL 9 (see Pharmacology: Pharmacodynamics under Actions).
Animal studies do not indicate reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
However, these data are considered insufficient to recommend use of GARDASIL 9 during pregnancy. Vaccination should be postponed until completion of pregnancy (see Pharmacology: Pharmacodynamics under Actions).
Breast-feeding: GARDASIL 9 can be used during breast-feeding.
A total of 92 women were breast-feeding during the vaccination period of the clinical studies of GARDASIL 9 in women aged 16 to 26 years. In the studies, vaccine immunogenicity was comparable between breast-feeding women and women who did not breast-feed. In addition, the adverse experience profile for breast-feeding women was comparable to that of the women in the overall safety population. There were no serious adverse experiences reported in infants who were breast-feeding during the vaccination period.
Fertility: No human data on the effect of GARDASIL 9 on fertility are available. Animal studies do not indicate harmful effects on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).