Adverse Events Following Pandemic A (H1N1) 2009 Monovalent Vaccines in Pregnant Women — Taiwan, November 2009–August 2010 英文参考文献.docVIP

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Adverse Events Following Pandemic A (H1N1) 2009 Monovalent Vaccines in Pregnant Women — Taiwan, November 2009–August 2010 英文参考文献.doc

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Adverse Events Following Pandemic A (H1N1) 2009 Monovalent Vaccines in Pregnant Women — Taiwan, November 2009–August 2010 英文参考文献

AdverseEventsFollowingPandemicA(H1N1)2009 MonovalentVaccinesinPregnantWomen—Taiwan, November2009–August2010 Wan-TingHuang1*,Wan-ChinChen1,Hwa-JenTeng1,Wei-IHuang2,Yu-WenHuang3,4,Chien-WenHsu3, Jen-HsiangChuang1 1TaiwanCentersforDiseaseControl,Taipei,Taiwan,2TaiwanDrugReliefFoundation,Taipei,Taiwan,3TaiwanFoodandDrugAdministration,Taipei,Taiwan,4College ofBioresourcesandAgriculture,InstituteofBiotechnology,NationalTaiwanUniversity,Taipei,Taiwan Abstract Background:Duringthe2009H1N1pandemic,pregnantwomenwereprioritizedtoreceivetheunadjuvantedorMF59H- adjuvanted pandemic A (H1N1) 2009 monovalent vaccines (‘‘2009 H1N1 vaccines’’) in Taiwan regardless of stage of pregnancy. Monitoringadverseevents following 2009H1N1vaccination in pregnant womenwas apriority forthemass immunizationcampaignbeginningNovember2009. Methods/Findings: We characterized reports to the national passive surveillance from November 2009 through August 2010 involving adverse events following 2009 H1N1 vaccines among pregnant women. Reports from the passive surveillancewerematchedtoalarge-linkeddatabaseonauniqueidentifier,dateofvaccination,anddateofdiagnosisina capture-recaptureanalysistoestimatethetruenumberofspontaneousabortionafter2009H1N1vaccination.Weverified 16 spontaneous abortions, 11 stillbirths, 4 neonatal deaths, 4 nonpregnancy-specific adverse events, and 2 inadvertent immunizations in recipients who were unaware of pregnancy at time of vaccination. The Chapman capture-recapture estimatoroftruenumberofspontaneousabortionafter2009H1N1vaccinationwas329(95%confidenceinterval[CI]196– 553).Ofthe14,474pregnantwomenwhoreceivedthe2009H1N1vaccines,theestimatedriskofspontaneousabortionwas 2.3 (95% CI, 1.4–3.8) per 100 pregnancies, compared with a local background rate of 12.8 (95% CI, 12.8–12.9) per 100 pregnancies. Conclusions: The passive surveillance provided rapid initial assessment of adverse events after 2009 H1N1 vaccination amongpregnantwomen.Itsfindingswerereassuringforthesafetyof2009H1N1