Pregnancy & Lactation : הריון/הנקה

4.6         Fertility, pregnancy and lactation

Pregnancy
Specific studies of the vaccine in pregnant women were not conducted. However, during the clinical development program, a total of 10,476 pregnancies were reported including 5,387 in women who had received Cervarix. Overall, the proportions of pregnant subjects who experienced specific outcomes (e.g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups.

Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development (see section 5.3).

These data are insufficient to recommend use of Cervarix during pregnancy.
Vaccination should, therefore, be postponed until after completion of pregnancy.

Breast-feeding
The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies.

Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.

Fertility

No fertility data are available.