Is Gardasil (Human Papillomavirus vaccine) safe during pregnancy?

From the Guidelines

Gardasil is not recommended during pregnancy, and vaccination should be delayed until after pregnancy as a precautionary measure. While there is no evidence that the HPV vaccine causes harm to a developing fetus, it has not been adequately studied in pregnant women 1. If a woman receives Gardasil while pregnant, no intervention is needed, but she should complete the vaccination series after delivery if doses remain. The Centers for Disease Control and Prevention maintains a pregnancy registry to monitor outcomes of women who inadvertently receive the vaccine while pregnant. The vaccine contains no live virus, only virus-like particles that cannot cause infection, which is reassuring regarding its biological mechanism. Some key points to consider:

• Women who are planning pregnancy do not need to delay conception after receiving Gardasil 1.
• After delivery, the vaccine is safe for breastfeeding mothers.
• For optimal protection, women should complete the full vaccination series before becoming pregnant if possible.
• The use of HPV vaccine is not recommended for pregnant women, and pregnant women should consider delaying receipt of the vaccine until after pregnancy 1.

From the FDA Drug Label

Available human data do not demonstrate vaccine-associated increase in risk of major birth defects and miscarriages when GARDASIL 9 is administered during pregnancy. There are no adequate and well-controlled studies of GARDASIL 9 in pregnant women Safety and effectiveness of GARDASIL 9 have not been established in pregnant women.

Gardasil Safety During Pregnancy:

• The available human data do not show an increased risk of major birth defects and miscarriages when Gardasil is administered during pregnancy.
• However, there are no adequate and well-controlled studies of Gardasil in pregnant women.
• The safety and effectiveness of Gardasil have not been established in pregnant women.
• A pregnancy registry is available to monitor pregnancy outcomes in women exposed to Gardasil during pregnancy 2, 2, 2.

From the Research

Safety of Gardasil During Pregnancy

• The safety of Gardasil during pregnancy has been evaluated in several studies, with most data indicating no increased risk of malformations or adverse events 3, 4.
• A study published in 2012 found that animal studies showed no increase in the risk of malformations after in utero exposure to the HPV 6/11/16/18 vaccine during the first trimester, and clinical trials and the Pregnancy Registry for Gardasil showed no particular pattern of malformations 3.
• Another study published in 2015 found that reports to the Vaccine Adverse Event Reporting System (VAERS) in pregnant women who received HPV4 vaccine did not show any unexpected patterns in maternal or fetal outcomes, although the most frequent pregnancy-specific adverse event was spontaneous abortion 4.
• A review of the safety and efficacy of HPV vaccines, including Gardasil, published in 2021 found that the vaccines are generally considered safe and efficacious, but further comprehensive and long-term studies are needed to critically assess safety and efficacy 5.

Recommendations for Gardasil Use During Pregnancy

• The Advisory Committee on Immunization Practices (ACIP) recommends that vaccines be used in pregnancy based on a comprehensive review of available scientific literature, including clinical trials and post-marketing surveillance data 6.
• However, Gardasil is not recommended during pregnancy as a precaution, although some women may be vaccinated shortly before conceiving or early during an undiagnosed pregnancy 3.
• Healthcare providers should be familiar with the recommendations for vaccinations during pregnancy and provide appropriate information to women who are vaccinated just before conceiving or early in pregnancy 6.

Adverse Events Associated with Gardasil Use During Pregnancy

• The most frequent pregnancy-specific adverse event associated with Gardasil use during pregnancy is spontaneous abortion, followed by elective terminations 4.
• Maternal fever is the most frequent non-pregnancy-specific adverse event associated with Gardasil use during pregnancy 4.
• There have been reports of major birth defects associated with Gardasil use during pregnancy, but these are rare and do not clearly implicate the vaccine 3, 4.