Document Detail

Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy.
MedLine Citation:
PMID:  22782418     Owner:  NLM     Status:  MEDLINE    
CONTEXT: Assessment of the fetal safety of vaccination against influenza A(H1N1)pdm09 in pregnancy has been limited.
OBJECTIVE: To investigate whether exposure to an adjuvanted influenza A(H1N1)pdm09 vaccine during pregnancy was associated with increased risk of adverse fetal outcomes.
DESIGN, SETTING, AND PARTICIPANTS: Registry-based cohort study based on all liveborn singleton infants in Denmark, delivered between November 2, 2009, and September 30, 2010. In propensity score-matched analyses, we estimated prevalence odds ratios (PORs) of adverse fetal outcomes, comparing infants exposed and unexposed to an AS03-adjuvanted influenza A(H1N1)pdm09 vaccine during pregnancy.
MAIN OUTCOME MEASURES: Major birth defects, preterm birth, and small size for gestational age.
RESULTS: From a cohort of 53,432 infants (6989 [13.1%] exposed to the influenza A[H1N1]pdm09 vaccine during pregnancy [345 in the first trimester and 6644 in the second or third trimester]), 660 (330 exposed) were included in propensity score-matched analyses of adverse fetal outcomes associated with first-trimester exposure. For analysis of small size for gestational age after second- or third-trimester exposure, 13,284 (6642 exposed) were included; for analyses of preterm birth, 12,909 (6543 exposed) were included. A major birth defect was diagnosed in 18 of 330 infants (5.5%) exposed to the vaccine in the first trimester, compared with 15 of 330 unexposed infants (4.5%) (POR, 1.21; 95% CI, 0.60-2.45). Preterm birth occurred in 31 of 330 infants (9.4%) exposed in the first trimester, compared with 24 of 330 unexposed infants (7.3%) (POR, 1.32; 95% CI, 0.76-2.31), and in 302 of 6543 infants (4.6%) with second- or third-trimester exposure, compared with 295 of 6366 unexposed infants (4.6%) (POR, 1.00; 95% CI, 0.84-1.17). Small size for gestational age was observed in 25 of 330 infants (7.6%) with first-trimester exposure compared with 31 of 330 unexposed infants (9.4%) (POR, 0.79; 95% CI, 0.46-1.37), and in 641 of 6642 infants (9.7%) with second- or third-trimester exposure, compared with 657 of 6642 unexposed infants (9.9%) (POR, 0.97; 95% CI, 0.87-1.09).
CONCLUSIONS: In this Danish cohort, exposure to an adjuvanted influenza A(H1N1)pdm09 vaccine during pregnancy was not associated with a significantly increased risk of major birth defects, preterm birth, or fetal growth restriction.
Björn Pasternak; Henrik Svanström; Ditte Mølgaard-Nielsen; Tyra G Krause; Hanne-Dorthe Emborg; Mads Melbye; Anders Hviid
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  JAMA     Volume:  308     ISSN:  1538-3598     ISO Abbreviation:  JAMA     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-07-11     Completed Date:  2012-07-12     Revised Date:  2014-09-17    
Medline Journal Info:
Nlm Unique ID:  7501160     Medline TA:  JAMA     Country:  United States    
Other Details:
Languages:  eng     Pagination:  165-74     Citation Subset:  AIM; IM    
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MeSH Terms
Adjuvants, Immunologic
Cohort Studies
Congenital Abnormalities / epidemiology*
Denmark / epidemiology
Fetal Growth Retardation / epidemiology*
Infant, Newborn
Infant, Small for Gestational Age
Influenza A Virus, H1N1 Subtype*
Influenza Vaccines / adverse effects*
Influenza, Human / prevention & control*
Odds Ratio
Pregnancy Outcome
Premature Birth / epidemiology*
Propensity Score
Registries / statistics & numerical data
Vaccination / statistics & numerical data
Young Adult
Reg. No./Substance:
0/Adjuvants, Immunologic; 0/Influenza Vaccines
Comment In:
JAMA. 2012 Jul 11;308(2):184-5   [PMID:  22782421 ]

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