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Multicenter Study
. 2013 Feb 4:346:f393.
doi: 10.1136/bmj.f393.

Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study

F Rubinstein  1 , P Micone, A Bonotti, V Wainer, A Schwarcz, F Augustovski, A Pichon Riviere, A Karolinski; EVA Study Research Group Estudio Embarazo y Vacuna Antigripal
Affiliations
Multicenter Study

Influenza A/H1N1 MF59 adjuvanted vaccine in pregnant women and adverse perinatal outcomes: multicentre study

F Rubinstein et al. BMJ. .

Abstract

Objective: To assess the risk of adverse perinatal events of vaccination of pregnant women with an MF59 adjuvanted vaccine.

Design: Cross sectional multicentre study.

Setting: 49 public hospitals in major cities in Argentina, from September 2010 to May 2011.

Participants: 30,448 mothers (7293 vaccinated) and their 30,769 newborns.

Main outcome measure: Primary composite outcome of low birth weight, preterm delivery, or fetal or early neonatal death up to seven days postpartum.

Results: Vaccinated women had a lower risk of the primary composite outcome (7.0% (n=513) v 9.3% (n=2160); adjusted odds ratio 0.80, 95% confidence interval 0.72 to 0.89). The propensity score analysis showed similar results. Adjusted odds ratios for vaccinated women were 0.74 (0.65 to 0.83) for low birth weight, 0.79 (0.69 to 0.90) for preterm delivery, and 0.68 (0.42 to 1.06) for perinatal mortality. These findings were consistent in further subgroup analysis. No significant differences in maternal outcomes were found.

Conclusion: This large study using primary data collection found that MF59 adjuvanted A/H1N1 influenza vaccine did not result in an increased risk of adverse perinatal events and suggested a lower risk among vaccinated women. These findings should contribute to inform stakeholders and decision makers on the prescription of vaccination against influenza A/H1N1 in pregnant women.

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Conflict of interest statement

Competing interests: All authors have completed the Unified Competing Interest form at http://www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: this study was funded by Novartis Argentina SA and conducted under an independent research grant to the Institute for Clinical Effectiveness and Health Policy; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

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Flow chart of study
See this image and copyright information in PMC

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