Gardasil Use In Pregnancy & Lactation

Use in Pregnancy: Studies in Female Rats: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/fetal development, parturition or postnatal development. QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) induced a specific antibody response against HPV types 6, 11, 16, and 18 in pregnant rats following one or multiple intramuscular injections. Antibodies against all 4 HPV types were transferred to the offspring during gestation and possibly during lactation.
Clinical Studies in Humans: There are, however, 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 QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL).
In clinical studies, women underwent urine pregnancy testing prior to administration of each dose of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL). Women who were found to be pregnant before completion of a 3-dose regimen of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) were instructed to defer completion of their vaccination regimen until resolution of the pregnancy. Such non-standard regimens resulted in Postdose 3 anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18 responses that were comparable to those observed in women who received a standard 0, 2, and 6 month vaccination regimen (see Dosage & Administration).
During clinical trials, 3,819 women (vaccine N=1,894 vs. placebo N=1,925) reported at least one pregnancy. The overall proportions of pregnancies 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), were 22.6% (446/1,973) in individuals who received GARDASIL and 23.1% (460/1,994) in individuals who received placebo.
Further sub-analyses were done to evaluate pregnancies with estimated onset within 30 days or more than 30 days from administration of a dose of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) or placebo. For pregnancies with estimated onset within 30 days of vaccination, 5 cases of congenital anomaly were observed in the group that received QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) compared to 1 case of congenital anomaly in the group that received placebo. Conversely, in pregnancies with onset more than 30 days following vaccination, 40 cases of congenital anomaly were observed in the group that received QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) compared with 33 cases of congenital anomaly in the group that received placebo. The types of anomalies observed were consistent (regardless of when pregnancy occurred in relation to vaccination) with those generally observed in pregnancies in women aged 16 through 45 years.
Thus, there is no evidence to suggest that administration of QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) adversely affects fertility, pregnancy, or infant outcomes.
Use in Lactation: It is not known whether vaccine antigens or antibodies induced by the vaccine are excreted in human milk.
QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) may be administered to lactating women.
QUADRIVALENT HUMAN PAPILLOMAVIRUS (TYPES 6, 11, 16, 18) RECOMBINANT VACCINE (GARDASIL) or placebo were given to a total of 1,133 women who were breast feeding at any time during the relevant Phase III clinical studies. In these studies, the rates of adverse experiences in the mother and the nursing infant were comparable between vaccination groups. In addition, vaccine immunogenicity was comparable among nursing mothers and women who did not nurse during the vaccine administration.