Pregnancy outcomes from the pregnancy registry of a human papillomavirus type 6/11/16/18 vaccine.
OBJECTIVE
To better describe the safety profile of pregnancy exposures to the human papillomavirus (HPV) type 6/11/16/18 vaccine by acquiring and analyzing postmarketing data on pregnancy outcomes (ie, live births, abortions, fetal deaths, and congenital anomalies).


METHODS
Enrollment criteria included an identifiable patient and health care provider from the United States, France, or Canada and exposure within 1 month before the date of onset of the last menstrual period or at any time during pregnancy. Outcomes of interest were pregnancy outcomes and birth defects. Prospectively reported cases (reported before the outcome of the pregnancy was known) were used for rate calculations.


RESULTS
For the 517 prospective reports with known outcome, 451 (87.2%) were live births, including three sets of twins. Of 454 neonates, 439 (96.7%) were normal. The overall rate of spontaneous abortion was 6.9 per 100 outcomes (95% confidence interval [CI] 4.8-9.6). The prevalence of major birth defects was 2.2 per 100 liveborn neonates (95% CI 1.05-4.05). There were seven fetal deaths (1.5 per 100 outcomes, 95% CI 0.60-3.09).


CONCLUSIONS
Rates of spontaneous abortions and major birth defects were not greater than the unexposed population rates. Although no adverse signals have been identified to date, the HPV6/11/16/18 vaccine is not recommended for use in pregnant women.


METHODS
III.
Dana
Adrian
A
From Merck Research Laboratories, West Point, Pennsylvania; and the Department of Pediatrics, University of Washington, Seattle, Washington.
Buchanan
Karyn M
KM
Goss
Mary Ann
MA
Seminack
Margaret M
MM
Shields
Kristine E
KE
Korn
Scott
S
Cunningham
Michael L
ML
Haupt
Richard M
RM
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology; D000022:Abortion, Spontaneous / Q000139:chemically induced; D000293:Adolescent; D000328:Adult; D002170:Canada / Q000453:epidemiology; D002648:Child; D005260:Female; D005313:Fetal Death / Q000139:chemically induced; D005602:France / Q000453:epidemiology; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D053918:Papillomavirus Vaccines / Q000009:adverse effects*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011358:Product Surveillance, Postmarketing; D012042:Registries; D014481:United States / Q000453:epidemiology; D055815:Young Adult
D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines