Pregnancy: The effect of Cervarix on embryo-foetal, peri-natal and post-natal survival and development has been assessed in rats. Such animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/foetal development, parturition or post-natal development.
Data in pregnant women collected as part of clinical trials, pregnancy registries, and epidemiological studies do not suggest that vaccination with Cervarix alters the risk of abnormal outcomes in neonates including birth defects. Data are insufficient to conclude whether or not vaccination with Cervarix affects the risk of spontaneous abortion. Women who are pregnant or trying to become pregnant, are advised to postpone vaccination until completion of pregnancy.
Lactation: 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.
Serological data suggest a transfer of anti-HPV16 and anti-HPV18 antibodies via the milk during the lactation period in rats. However, it is unknown whether vaccine-induced antibodies are excreted in human breast milk.