tetano
Editor, Senior Moderator
Drug Saf. 2016 Dec 17. [Epub ahead of print]
[h=1]Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010-May 2016.[/h] Moro P[SUP]1[/SUP], Baumblatt J[SUP]2[/SUP], Lewis P[SUP]3[/SUP], Cragan J[SUP]4[/SUP], Tepper N[SUP]5[/SUP], Cano M[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]INTRODUCTION:[/h] 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).
[h=4]OBJECTIVES:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] As in 2009-2010, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016.
PMID: 27988883 DOI: 10.1007/s40264-016-0482-1
[PubMed - as supplied by publisher]
[h=1]Surveillance of Adverse Events After Seasonal Influenza Vaccination in Pregnant Women and Their Infants in the Vaccine Adverse Event Reporting System, July 2010-May 2016.[/h] Moro P[SUP]1[/SUP], Baumblatt J[SUP]2[/SUP], Lewis P[SUP]3[/SUP], Cragan J[SUP]4[/SUP], Tepper N[SUP]5[/SUP], Cano M[SUP]3[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]INTRODUCTION:[/h] 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).
[h=4]OBJECTIVES:[/h] 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.
[h=4]METHODS:[/h] 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.
[h=4]RESULTS:[/h] 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.
[h=4]CONCLUSION:[/h] As in 2009-2010, no new or unexpected patterns in maternal or fetal outcomes were observed during 2010-2016.
PMID: 27988883 DOI: 10.1007/s40264-016-0482-1
[PubMed - as supplied by publisher]