Final report on exposure during pregnancy from a pregnancy registry for quadrivalent human papillomavirus vaccine.

OBJECTIVE: To better describe the safety profile of pregnancy exposures to the qHPV vaccine by acquiring and analyzing post-marketing data on pregnancy outcomes. METHODS: This is a voluntary, post-marketing prenatal vaccine exposure registry. 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 were used for rate calculations. RESULTS: For the 1752 prospective reports with known outcome, 1518 (86.6%) were live births, including ten twin pregnancies. Of 1527 neonates, 1444 (94.6%) had no congenital anomalies. The overall rate of spontaneous abortion was 6.7 per 100 outcomes (95% confidence interval [CI] 5.5-8.2). The prevalence of major birth defects was 2.4 per 100 live-born neonates (95% CI 1.7-3.3). There were 12 fetal deaths (0.8 per 100 outcomes, 95% CI 0.4-1.4). CONCLUSION: Rates of spontaneous abortions and major birth defects were not greater than the general population rates. Although no adverse signals have been identified to date, the qHPV vaccine is not recommended for use in pregnant women.

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). CONCLUSION: 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. LEVEL OF EVIDENCE: III.

Varicella vaccine exposure during pregnancy: data from 10 Years of the pregnancy registry.

BACKGROUND: The Pregnancy Registry for Varivax (Merck) was established to monitor for congenital varicella syndrome or other birth defects in the offspring of women who were exposed to varicella vaccine while pregnant. METHODS: The registry receives voluntary reports from health care providers or consumers about women given the vaccine 3 months before or during pregnancy. Follow-up is conducted to obtain and classify pregnancy outcomes. All reports are evaluated for the presence of birth defects. Outcomes from prospectively reported pregnancy exposures are used to calculate rates and 95% confidence intervals. RESULTS: From 17 March 1995 through 16 March 2005, 981 women were enrolled. Pregnancy outcomes were available for 629 prospectively enrolled women. Among the 131 live births to varicella-zoster virus-seronegative women, there was no evidence of congenital varicella syndrome (rate, 0% [95% confidence interval [CI], 0%-6.7%]), and major birth defects were observed in 3 infants (rate, 3.7% [95% CI, 0.8%-10.7%]). CONCLUSIONS: Although the numbers of exposures are not sufficient to rule out a very low risk, data collected in the pregnancy registry to date do not support a relationship between the occurrence of congenital varicella syndrome or other birth defects and varicella vaccine exposure during pregnancy.