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Influenza H1N1 vaccination and adverse pregnancy outcome

  • PERINATAL EPIDEMIOLOGY
  • Published:
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Abstract

Although vaccines against influenza can reduce maternal morbidity and mortality, large-scale data on adverse effects in the offspring are scarce. Historical cohort study in Stockholm County, Sweden. We linked H1N1 vaccination data (Pandemrix®, a mono-valent AS03 adjuvanted H1N1 vaccine) with pregnancy and birth data from 21,087 women with singleton offspring conceived between February 2009 and January 2010 (vaccinated during pregnancy: n = 13,297 vs. unvaccinated: n = 7,790). Data were analysed by conceptualizing the observational cohort as a series of nested cohorts defined at each week of gestation. Logistic regression estimated odds ratios (ORs) for low birth weight (LBW, <2,500 g), preterm birth (<37 completed weeks), small-for-gestational age (SGA, <10th percentile of the gestational age-specific birth weight within the cohort), low 5-min Apgar score (<7), and caesarean section. Data were adjusted for potential confounders, including maternal age, body mass index, smoking, parity, civil status and comorbidities. Compared with infants of non-vaccinated women, infants of vaccinated women had similar adjusted ORs (95 % CI) for LBW (0.91; 0.79–1.04), preterm birth (0.99; 0.89–1.10), SGA (0.97; 0.90–1.05), low Apgar score (1.05, 0.84–1.31), and a marginal risk reduction for caesarean section (0.94, 0.89–0.99). H1N1 vaccination during pregnancy, using an AS03-adjuvanted vaccine, does not appear to adversely influence offspring risks of LBW, preterm birth, SGA, or low Apgar score. Our results suggest that this vaccine is safe for the offspring when used in different stages of pregnancy.

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Abbreviations

CI:

Confidence interval

LBW:

Low birth weight

OR:

Odds ratio

SGA:

Small for gestational age

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Acknowledgments

This project was supported by grants from the Swedish Research Council (Medicine), and the Swedish Council for Working Life and Social Research (FAS).

Ethical approval

This project (2009/1952-31/4) was approved by the Research Ethics Committee of the Karolinska Institute, Sweden on January 13, 2010.

Conflict of interest

JFL was funded by the Swedish Research Council (Medicine), OS was funded by the Swedish Society of Medicine. LR was partially supported by grants from the Compagnia san Paolo/Firms and the Italian Association for Cancer Research.

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Authors and Affiliations

  1. Clinical Epidemiology Unit, Department of Medicine, Karolinska Institutet, Stockholm, Sweden

    Jonas F. Ludvigsson, Daniela Zugna, Sven Cnattingius, Anders Ekbom & Olof Stephansson

  2. Department of Pediatrics, Örebro University Hospital, Örebro, Sweden

    Jonas F. Ludvigsson

  3. Cancer Epidemiology Unit, Department of Medical Sciences, University of Turin and CPO-Piemonte, Turin, Italy

    Daniela Zugna & Lorenzo Richiardi

  4. Unit of Infectious Diseases, Department of Medicine, Karolinska Institutet, Stockholm, Sweden

    Åke Örtqvist

  5. Department of Communicable Diseases Control and Prevention, Stockholm County Council, Stockholm, Sweden

    Åke Örtqvist

  6. Medical Product Agency, Uppsala, Sweden

    Ingemar Persson

  7. Department of Women’s and Children’s Health, Karolinska Institutet and Hospital, Stockholm, Sweden

    Olof Stephansson

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  1. Jonas F. Ludvigsson
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Correspondence to Jonas F. Ludvigsson.

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Disclaimer This manuscript represents the views of the authors, not necessarily those of the Swedish drug regulatory agency (Medical Products Agency) where one of the authors is employed (IP).

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Ludvigsson, J.F., Zugna, D., Cnattingius, S. et al. Influenza H1N1 vaccination and adverse pregnancy outcome. Eur J Epidemiol 28, 579–588 (2013). https://doi.org/10.1007/s10654-013-9813-z

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  • DOI: https://doi.org/10.1007/s10654-013-9813-z

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