| アブストラクト | INTRODUCTION: Routine immunization of pregnant women with seasonal inactivated influenza vaccines (IIVs) is recommended in all trimesters of pregnancy. A review of the Vaccine Adverse Event Reporting System (VAERS) during 1990-2009 did not find any unexpected patterns of pregnancy complications or fetal outcomes after administration of IIV or live attenuated influenza vaccines (LAIVs). During the 2009-2010 pandemic influenza A (H1N1) vaccination campaign, a study noted that the number of VAERS reports from pregnant women who received the H1N1 2009 inactivated monovalent vaccine (n = 288) increased compared with 1990-2009 seasonal IIV pregnancy reports (n = 148). OBJECTIVES: The objective of this study was to assess the safety of seasonal influenza vaccines in pregnant women and their infants whose reports were submitted to VAERS during 2010-2016. METHODS: We searched VAERS for US reports of adverse events (AEs) in pregnant women who received IIV or LAIV from 1 July 2010 through 6 May 2016. Clinicians reviewed reports and available medical records and assigned a primary clinical category for each report. Reports were coded as serious based on the Code of Federal Regulations. RESULTS: We identified 671 reports after seasonal influenza vaccines administered to pregnant women: 544 after IIV and 127 after LAIV. Serious events occurred among 61 (11.2%) reports following IIV and one (0.8%) report following LAIV. No deaths were reported. Among reports with trimester information (n = 296), IIV was administered during the first trimester in 116 (39.2%). Among IIV reports, the most frequent pregnancy-specific AE was spontaneous abortion in 62 (11.4%) reports, followed by stillbirth in ten (1.8%) and preterm delivery in six (1.1%). The most common non-pregnancy-specific AEs were injection-site reactions (55 [10.1%]). Neonatal or infant outcomes were reported in 22 (4.0%) reports, seven of which had major birth defects of different types and no neonatal deaths. CONCLUSION: As in 2009-2010, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016. |
|---|
| 組織名 | Immunization Safety Office, Division of Healthcare Quality Promotion, National;Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for;Disease Control and Prevention (CDC), 1600 Clifton Rd, MS D26, Atlanta, GA,;30329, USA. pmoro@cdc.gov.;Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for;Biologics Evaluation and Research, US Food and Drug Administration (FDA), Silver;Spring, MD, USA.;30329, USA.;Birth Defects Branch, Division of Congenital and Developmental Disabilities,;National Center on Birth Defects and Developmental Disabilities (NCBDDD), CDC,;Atlanta, GA, USA.;Women's Health and Fertility Branch, Division of Reproductive Health, National;Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), CDC, |
|---|
