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.

Measles, mumps, and rubella virus vaccine (M-M-R™II): a review of 32 years of clinical and postmarketing experience.

M-M-R™II (measles, mumps, and rubella virus vaccine live; Merck, Sharp, & Dohme Corp.) is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals ≥ 12 months of age. Before the vaccine era, these viruses infected most exposed individuals, with subsequent morbidity and mortality. One of the greatest achievements of public health has been to eliminate these 3 diseases in large geographic areas. The safety profile of M-M-R™II is described using data from routine global postmarketing surveillance. Postmarketing surveillance has limitations (including incomplete reporting of case data), but allows collection of real-world information on large numbers of individuals, who may have concurrent medical problems excluding them from clinical trials. It can also identify rare adverse experiences (AEs). Over its 32-year history, ≈ 575 million doses of M-M-R™II have been distributed worldwide, with 17,536 AEs voluntarily reported for an overall rate of 30.5 AEs/1,000,000 doses distributed. This review provides evidence that the vaccine is safe and well-tolerated.

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.