Pharmacovigilance monitoring of a cohort of pregnant women vaccinated against influenza A(H1N1) variant virus in the Nord-Pas de Calais region of northern France

Abstract

Objective: During the 2009-2010 influenza A variant virus (A(H1N1)v) pandemic in France, a national pharmacovigilance program was set up to monitor vaccinated, pregnant women, especially the reactogenicity of the vaccine and its impact on the outcome of pregnancy and on the newborn. Here, we present the results for the cohort of pregnant women constituted in the Nord-Pas de Calais region of northern France.

Study design: Vaccinated pregnant women were included in the study by the region's vaccination centers between November 2009 and April 2010.

Results: Eight hundred and six pregnant women were included and 781 were followed up until delivery. The risk of adverse events after vaccination and the maternal, fetal and neonatal medical conditions in our cohort did not appear different from the risk observed in the general population.

Conclusions: Our results suggest that A(H1N1)v vaccination of pregnant women did not have an adverse impact on the pregnancies' course and outcome.

Keywords: Influenza A(H1N1); Influenza vaccine; Neonates; Pharmacovigilance; Pregnancy.