Can Gardasil (Human Papillomavirus vaccine) be administered 1 month before pregnancy?

From the Guidelines

Gardasil (HPV vaccine) can be safely administered 1 month before pregnancy, though it's not recommended to become pregnant within 1-2 months after vaccination as a general precaution. The vaccine is not recommended during pregnancy, not because it's known to be harmful, but because there isn't enough research on its effects during pregnancy 1. Gardasil is an inactivated vaccine that contains no live virus, so it theoretically poses minimal risk to a developing fetus. If you receive Gardasil and then discover you're pregnant, there's no need for concern as no adverse pregnancy outcomes have been linked to the vaccine.

Key Considerations

• The standard Gardasil regimen consists of three doses given over 6 months (at 0,2, and 6 months), so ideally you would complete the series before conception.
• If you're planning pregnancy, it's best to discuss timing with your healthcare provider, who might recommend either completing the vaccine series before conception or waiting until after pregnancy to begin or complete vaccination.
• According to the most recent guidelines, HPV vaccination is not recommended for use in pregnant women, however, pregnancy testing is not needed before vaccination 1.

Special Circumstances

• If a woman is found to be pregnant after initiating the HPV vaccination series, no intervention is needed; the remainder of the 3-dose series should be delayed until completion or termination of pregnancy 1.
• HPV vaccine can be given in special circumstances, such as when a patient has an abnormal or equivocal Papanicolaou test result, when a patient is breastfeeding, or when a patient is immunocompromised because of disease or medication 1.

From the FDA Drug Label

Among such pregnancies, there were 62 and 55 with known outcomes (excluding ectopic pregnancies and elective terminations) for GARDASIL 9 and GARDASIL, respectively, including 44 and 48 live births, respectively. A five-year pregnancy registry enrolled 2,942 women who were inadvertently exposed to GARDASIL within one month prior to the last menstrual period (LMP) or at any time during pregnancy, 2,566 of whom were prospectively followed Rates of miscarriage and major birth defects were 6.8% of pregnancies (111/1,640) and 2. 4% of live born infants (37/1,527), respectively.

Administration of Gardasil 1 month before pregnancy:

• The available data do not demonstrate a vaccine-associated increase in risk of major birth defects and miscarriages when GARDASIL 9 is administered during pregnancy.
• Rates of assessed outcomes in the prospective population were consistent with estimated background rates.
• It can be administered 1 month before pregnancy, but the decision should be made on a case-by-case basis, considering the individual's risk factors and medical history 2.

From the Research

Gardasil Vaccine Administration Before Pregnancy

• The Gardasil vaccine is not recommended for use in pregnant women, but it is not a live vaccine, so it is not expected to be associated with an increased risk 3.
• According to the manufacturer's pregnancy registry and phase 3 clinical trials, there is no indication of an increased risk of fetal malformations or other adverse effects due to the vaccine 3.
• However, it is generally preferred to administer vaccines either prior to conception or in the postpartum period 4.
• The vaccine is contraindicated in individuals who are hypersensitive to the active substances or to any of the excipients of the vaccine, patients with bleeding abnormalities or patients on anticoagulant therapy, and during pregnancy 5.
• If a woman is vaccinated shortly before conceiving or early during an undiagnosed pregnancy, she should receive appropriate information, and active pharmacovigilance must continue 6.
• There are limited data on exposure to HPV vaccines during the first trimester of pregnancy, but available data on the HPV 6/11/16/18 vaccine are relatively reassuring 6.

Key Considerations

• The Gardasil vaccine is a non-viable vaccine composed of recombinant HPV proteins, and as a precaution, it should not be given during pregnancy 6.
• Maternal immunization can reduce the risk of vaccine-preventable diseases that may occur in the first months of life before the start or completion of the suggested vaccination schedule 7.
• The administration of vaccines is not usually recommended in pregnant women because of a fear of severe adverse events for the fetus, but contraindication to vaccination applies only to vaccines based on live attenuated viruses 7.

Vaccine Safety

• Animal studies have shown no increase in the risk of malformations after in utero exposure to the HPV 6/11/16/18 vaccine during the first trimester 6.
• Clinical trials and the Pregnancy Registry for Gardasil have shown no particular pattern of malformations with the quadrivalent vaccine 3, 6.
• The rate of congenital malformations was similar to that in the control population for the HPV 16/18 vaccine 6.