Gardasil Use In Pregnancy & Lactation

Specific studies of Gardasil in pregnant women were not conducted. However, during the prelicensure clinical development program, 2266 women (vaccine=1115 vs placebo=1151) reported at least 1 pregnancy. Overall, the proportions of pregnancies with an adverse outcome were comparable in subjects who received Gardasil and subjects who received placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received Gardasil compared to 0 cases of congenital anomaly in the group that received placebo. Conversely, in pregnancies with onset >30 days following vaccination, 10 cases of congenital anomaly were observed in the group that received Gardasil compared with 16 cases of congenital anomaly in the group that received placebo. The type of anomalies observed were consistent with those generally observed in pregnancies in women aged 16-26 years.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development (see Toxicology under Actions).
The data on Gardasil administered during pregnancy did not indicate any safety signal. However, these data are insufficient to recommend use of Gardasil during pregnancy.
Vaccination should, therefore, be postponed until after completion of pregnancy.
A total of 995 breastfeeding mothers were given Gardasil or placebo during the vaccination period of the clinical trials. The rates of adverse reactions in the mother and the breastfed infant were comparable between the vaccination and the placebo groups. In addition, vaccine immunogenicity was comparable among breastfeeding mothers and women who did not breastfeed during Gardasil administration.
Gardasil can be given to breastfeeding women.