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Safety of MF59-adjuvanted A/H1N1 Influenza Vaccine in Pregnancy: a Comparative Cohort Study

Overview
Journal Am J Obstet Gynecol
Publisher Elsevier
Specialty Gynecology & Obstetrics
Date 2012 Sep 4
PMID 22939717
Citations 38
Authors
Terho Heikkinen
James Young
Erik van Beek
Henk Franke
Thomas Verstraeten
John G Weil
Giovanni Della Cioppa
Affiliations
Soon will be listed here.
Abstract

Objective: The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy.

Study Design: This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates.

Results: No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters.

Conclusion: There was no evidence of a safety risk for MF59-adjuvanted A/H1N1 vaccination in pregnant women; protection was observed against premature birth.

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