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No Concerning Safety Patterns for HPV4 During Pregnancy

Healio , 05/07/2014

Healio reported on a study of adverse effects in women who were exposed to the quadrivalent HPV vaccine during pregnancy. The Advisory Committee on Immunization Practices does not advise use of the vaccine for pregnant women. Pedro Moro, MD, MPH, of CDC’s Immunization Safety Office and colleagues assessed HPV4 safety in pregnant women and their infants using data from the Vaccine Adverse Event Reporting System, an FDA- and CDC-sponsored national vaccine safety surveillance program. The researchers reviewed reports of adverse events in pregnant women who received HPV4 vaccine during pregnancy between 2005 and 2012. Serious reports were those that resulted in death, hospitalization, and lengthy hospitalization or permanent disability. The researchers found 1,261 reports of adverse events, and 8 percent were considered serious. Approximately 72 percent of reports were from the manufacturer’s pregnancy registry. Most of the pregnant women (91 percent) had received HPV4 in their first trimester. There were no maternal deaths. Of the women, 195 experienced spontaneous abortion––the most common adverse event––followed by elective termination of the pregnancy (9 percent), and premature delivery (7.9 percent). Of 385 infant births, 53 infants had major birth defects and five died. The researchers concluded that, in general, the vaccine revealed no safety patterns of concern. This study, Abstract #S26, was presented at the Annual Conference on Vaccine Research; April 28-30, 2014; Bethesda, MD.

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