Gardasil 9 Use In Pregnancy & Lactation

Pregnancy: Studies in Female Rats: Reproduction studies have been performed in female rats at a dose approximately 240 times the human dose (mg/kg basis) and have revealed no evidence of impaired female fertility or harm to the fetus due to HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9).
An evaluation of the effect of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) on embryo-fetal, pre- and postweaning development was conducted in studies using rats. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or pre- and postweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted. In addition, there were no treatment-related effects on developmental signs, behavior, reproductive performance, or fertility of the offspring. HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) induced a specific antibody response against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in pregnant rats following one or multiple intramuscular injections. Antibodies against all 9 HPV types were transferred to the offspring during the period of gestation and lactation.
Clinical Studies in Humans: There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, pregnancy should be avoided during the vaccination regimen for HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9).
In clinical studies, women underwent serum or urine pregnancy testing prior to administration of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9). Women who were found to be pregnant before completion of a 3-dose regimen of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) were instructed to defer completion of their vaccination regimen until resolution of the pregnancy.
The overall proportion of pregnancies occurring at any time during the studies that resulted in an adverse outcome defined as the combined numbers of spontaneous abortion, late fetal death and congenital anomaly cases out of the total number of pregnancy outcomes for which an outcome was known (and excluding elective terminations), was 12.9% (174/1,353) in women who received HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) and 14.4% (187/1,303) in women who received GARDASIL. The proportions of adverse outcomes observed were consistent with pregnancy outcomes observed in the general population.
Further sub-analyses were conducted to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) or GARDASIL. For pregnancies with estimated onset within 30 days of vaccination, no cases of congenital anomaly were observed in women who have received HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) or GARDASIL. In pregnancies with onset more than 30 days following vaccination, 30 and 23 cases of congenital anomaly were observed in women who have received HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) and GARDASIL, respectively. The types of anomalies observed were consistent (regardless of when pregnancy occurred in relation to vaccination) with those generally observed in pregnancies in the general population.
Thus, there is no evidence to suggest that administration of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) adversely affects fertility, pregnancy, or infant outcomes.
Nursing Mothers: HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) may be administered to lactating women.
It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk.
A total of 92 women were breast feeding during the vaccination period of the clinical studies for HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) in women aged 16 to 26 years. In these studies, vaccine immunogenicity was comparable between nursing women and women who did not nurse. In addition, the adverse experience profile for nursing 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 nursing during the vaccination period.