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BMJ. 2014 May 29;348:g3361. doi: 10.1136/bmj.g3361.

Evaluation of safety of A/H1N1 pandemic vaccination during pregnancy: cohort study.

Author information

  • 1Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy Pharmacovigilance Unit, Italian Medicines Agency (AIFA), 00187 Rome, Italy.
  • 2Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy.
  • 3Unit for Preventive Medicine, General Directorate for Health, The Lombardy Region, 20124 Milan, Italy.
  • 4Regional Centre for Pharmacovigilance, General Directorate for Health, The Lombardy Region, 20124 Milan, Italy.
  • 5Unit for Local Health Service Governance, General Directorate for Health, The Lombardy Region, 20124 Milan, Italy.
  • 6Pharmacoepidemiology Unit, National Centre for Epidemiology, National Institute of Health, Viale Regina Elena 299, 00161 Rome, Italy giuseppe.traversa@iss.it.

Abstract

OBJECTIVE:

To assess the risk of maternal, fetal, and neonatal outcomes associated with the administration of an MF59 adjuvanted A/H1N1 vaccine during pregnancy.

DESIGN:

Historical cohort study.

SETTING:

Singleton pregnancies of the resident population of the Lombardy region of Italy.

PARTICIPANTS:

All deliveries between 1 October 2009 and 30 September 2010. Data on exposure to A/H1N1 pandemic vaccine, pregnancy, and birth outcomes were retrieved from regional databases. Vaccinated and non-vaccinated women were compared in a propensity score matched analysis to estimate risks of adverse outcomes.

MAIN OUTCOME MEASURES:

Main maternal outcomes included type of delivery, admission to intensive care unit, eclampsia, and gestational diabetes; fetal and neonatal outcomes included perinatal deaths, small for gestational age births, and congenital malformations.

RESULTS:

Among the 86,171 eligible pregnancies, 6246 women were vaccinated (3615 (57.9%) in the third trimester and 2557 (40.9%) in the second trimester). No difference was observed in terms of spontaneous deliveries (adjusted odds ratio 1.02, 95% confidence interval 0.96 to 1.08) or admissions to intensive care units (0.95, 0.47 to 1.88), whereas a limited increase in the prevalence of gestational diabetes (1.26, 1.04 to 1.53) and eclampsia (1.19, 1.04 to 1.39) was seen in vaccinated women. Rates of fetal and neonatal outcomes were similar in vaccinated and non-vaccinated women. A slight increase in congenital malformations, although not statistically significant, was present in the exposed cohort (1.14, 0.99 to 1.31).

CONCLUSIONS:

Our findings add relevant information about the safety of the MF59 adjuvanted A/H1N1 vaccine in pregnancy. Residual confounding may partly explain the increased risk of some maternal outcomes. Meta-analysis of published studies should be conducted to further clarify the risk of infrequent outcomes, such as specific congenital malformations.

© Trotta et al 2014.

Comment in

PMID:
24874845
[PubMed - indexed for MEDLINE]
PMCID:
PMC4038133
Free PMC Article

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