Evidence that Fetal Exposure to Quadrivalent HPV Vaccine During Pregnancy Is Safe

Summary and Comment |
March 29, 2017

Evidence that Fetal Exposure to Quadrivalent HPV Vaccine During Pregnancy Is Safe

  1. Anna Wald, MD, MPH

Maternal human papillomavirus vaccination did not confer excess risk for several adverse pregnancy outcomes.

  1. Anna Wald, MD, MPH

Evaluating the safety of vaccination during pregnancy is complicated by the general avoidance of routine immunizations other than those that are indicated (e.g., influenza vaccine); hence, reliable data are sparse regarding outcomes in women who inadvertently received the human papillomavirus (HPV) vaccine before becoming aware they were pregnant. Investigators queried nationwide prospective medical records of pregnant Danish women from October 2006 to November 2013 to determine whether outcomes differed among women who received the quadrivalent HPV vaccine during pregnancy versus those who did not. About 500,000 singleton pregnancies were identified, including some 1700 exposed to the vaccine.

Analyses adjusted for potential confounders showed that risk for major birth defects, spontaneous abortions, preterm birth, low birthweight, small for gestational age, or stillbirth was not significantly higher in women who received HPV vaccination during pregnancy than in those who did not.

Comment

The protein-based quadrivalent HPV vaccine would not inherently be expected to pose risks during pregnancy (and the FDA classifies it as Category B on the basis of animal studies showing no evidence of impaired fertility or fetal harm). Unlike infections such as influenza, pertussis, and tetanus, HPV infection itself does not confer risk for adverse pregnancy outcomes; thus, clinical trials to assess the safety of HPV vaccination of pregnant women are unlikely to be conducted. Women who receive the HPV vaccine and subsequently learn that they are pregnant can be reassured. Nonetheless, this vaccine is ideally administered prior to initiation of sexual activity (i.e., well before pregnancy).

Editor Disclosures at Time of Publication

  • Disclosures for Anna Wald, MD, MPH at time of publication Consultant / Advisory board AiCuris; Merck (DSMB) Royalties UpToDate Grant / Research support NIH/National Cancer Institute; NIH/National Institute of Allergy and Infectious Diseases; Genocea Biosciences; Vical Editorial boards Sexually Transmitted Diseases; Sexually Transmitted Infections Leadership positions in professional societies International Society for Sexually Transmitted Diseases Research (Board Member)

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