HPV vaccine: unintentional exposure in pregnancy no cause for alarm

  • Landazabal CS & al.
  • Vaccine
  • 16 Jan 2019

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • Postmarketing Vaccine Adverse Event Reporting System (VAERS) data show no unexpected adverse events (AEs) related to 9-valent type HPV vaccine (Gardasil) (9vHPV) exposure among pregnant women.

Why this matters

  • CDC does not recommend HPV vaccination in pregnant women, even though data have not causally linked HPV vaccine to AEs.
  • Delay HPV vaccine initiation in pregnant women; if series have been initiated, wait until postbirth to resume series.
  • Assure pregnant women with inadvertent exposure that no significant safety signals have emerged.

Key results

  • 80 reports.
  • 9vHPV was administered during first trimester in 75% (45/60) of reports with known gestational age.
  • 73.2% (n=60) submitted due to vaccine exposure during pregnancy did not describe an AE.
  • 3.7% (n=3) reported spontaneous abortion, 2.4% (n=2) vaginal bleeding.
  • Infant outcomes: 1.2% (n=1) excessive weight loss, 1.2% (n=1) renal impairment/manifestations.
  • 20.7% (n=17) vaccination error reports, including: 29.4% (n=5) incorrect administration, administration to inappropriately aged recipient, or inappropriate schedule, 11.8% (n=2) extra dose.
  • AEs: injection site reaction (n=2), spontaneous abortion (n=1), polyhydramnios (n=1), proteinuria (n=1), unspecified (n=1).

Study design

  • VAERS surveillance data review evaluating reports of pregnant women exposed to 9vHPV, 2014-2017.
  • Funding: CDC.

Limitations

  • Incomplete data, some report inaccuracies.
  • Inability to calculate AE rates.
  • Under-, overreporting.