tetano
Editor, Senior Moderator
American Journal of Obstetrics & Gynecology
Article in Press
Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study
Terho Heikkinen, MD
,
James Young, MS
,
Erik Van Beek, MD
,
Henk Franke, MD
,
Thomas Verstraeten, MD
,
John G. Weil, MD
,
Giovanni Della Cioppa, MD
Received 13 January 2012; received in revised form 27 April 2012; accepted 9 July 2012. published online 16 July 2012.
Accepted Manuscript
Abstract
PDF
Abstract
Objectives
The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy.
Study Design
Observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated versus 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 birth weight, neonatal deaths or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard: 0.69; 95% CI: 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.
http://www.ajog.org/article/S0002-9378(12)00744-2/abstract
Article in Press
Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study
Terho Heikkinen, MD
,
James Young, MS
,
Erik Van Beek, MD
,
Henk Franke, MD
,
Thomas Verstraeten, MD
,
John G. Weil, MD
,
Giovanni Della Cioppa, MD
Received 13 January 2012; received in revised form 27 April 2012; accepted 9 July 2012. published online 16 July 2012.
Accepted Manuscript
Abstract
Abstract
Objectives
The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy.
Study Design
Observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated versus 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 birth weight, neonatal deaths or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard: 0.69; 95% CI: 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.
http://www.ajog.org/article/S0002-9378(12)00744-2/abstract