Gardasil 9 Use In Pregnancy & Lactation

Pregnancy: Post-marketing data on pregnant women indicates no malformative nor foeto/neonatal toxicity of Gardasil 9 when administered during pregnancy.
Animal studies do not indicate reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
A six-year pregnancy registry for Gardasil 9 prospectively followed 180 women of which there were 69 pregnancies with known outcomes. Frequencies of miscarriage and major birth defects were 4.3% of pregnancies (3/69) and 4.5% of live born infants (3/67), respectively. These frequencies were consistent with estimated background frequencies. These data support similar findings from a five-year pregnancy registry for qHPV vaccine in which 1,640 pregnancies with known outcomes were included.
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 vaccine-related 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).