Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark

Pasternak, Björn; Svanström, Henrik; Mølgaard-Nielsen, Ditte; Krause, Tyra Grove; Emborg, Hanne‐Dorthe; Melbye, Mads; Hviid, Anders

doi:10.1136/bmj.e2794

Cited by 116 publications

(103 citation statements)

References 24 publications

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“…The C-statistic (an estimate of the ability of the propensity score model to predict vaccination status) was 0.81 for first-trimester exposure and 0.62 for second-or third-trimester exposure. After 1:1 propensity score matching, 660 (330 exposed) infants were included in analyses of adverse fetal outcomes associated with vaccination in the first trimester, and 13 284 (6642 exposed) in analyses of adverse fetal outcomes associated with vaccination in the second or (16) 49 (14) 54 (16) 49 (15) 7472 (16) 727 (11) 751 (11) 727 (11) (21) 68 (21) 72 (22) 8095 (17) 1329 (20) 1321 (20) 1327 (20 (11) 48 (14) 36 (11) 43 (13) 5038 (11) 867 (13) 875 (13) 867 (13) Population density 100-199 inhabitants/km 2 4693 (20) 65 (19) 67 (20) 63 (19) 9573 (21) 1241 (19) 1219 (18) 1241 (19) Population density 50-99 inhabitants/km 2 6074 (27) 78 (23) 72 (22) 77 (23) 12 607 (27) 1596 (24) 1551 (23) 1596 (24) Population density Յ49 inhabitants/km 2 1115 (5) 16 (5) 23 (7) 14 (4) 2336 (5) 277 (4) 264 (4) 277 (4) Place (4) 16 (5) 15 …”

Section: Study Cohortmentioning

confidence: 99%

Risk of Adverse Fetal Outcomes Following Administration of a Pandemic Influenza A(H1N1) Vaccine During Pregnancy

Pasternak¹,

Svanström²,

Mølgaard-Nielsen³

et al. 2012

JAMA

128

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HE 2009 INFLUENZA A(H1N1) p a n d e m i c p u t p r e g n a n t women at increased risk of morbidity, mortality, and poor pregnancy outcomes. [1][2][3][4] Pregnant women were among the main target groups prioritized for vaccination against influenza A(H1N1)pdm09, 5 and an estimated 2.4 million women were vaccinated during pregnancy in the United States alone. 6 However, assessment of the fetal safety of H1N1 vaccination in pregnancy has been limited to a few pharmacovigilance reports and descriptive cohort studies. [6][7][8][9][10][11][12][13][14] In a registry-based cohort study, we investigated whether exposure to an AS03-adjuvanted influenza A(H1N1) pdm09 vaccine in pregnancy was associated with increased risk of major birth defects, preterm birth, and fetal growth restriction. METHODSWe conducted a nationwide registrybased cohort study of liveborn infants in Denmark. Individual-level data on H1N1 vaccination during pregnancy and potential confounders in cohort moth-

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Section: Study Cohortmentioning

confidence: 99%

Risk of Adverse Fetal Outcomes Following Administration of a Pandemic Influenza A(H1N1) Vaccine During Pregnancy

Pasternak¹,

Svanström²,

Mølgaard-Nielsen³

et al. 2012

JAMA

128

View full text Add to dashboard Cite

show abstract

“…None showed an increased risk on adverse pregnancy outcomes. [12][13][14][15][16][17][18][19] The majority of the studies concerned the effect of Pandemrix â , adjuvanted with ASO3. None of the studies included follow up of the offspring up to 1 year of age.…”

mentioning

confidence: 99%

Safety of vaccination against influenza A (H1N1) during pregnancy in the Netherlands: results on pregnancy outcomes and infant's health: cross‐sectional linkage study

Maas

Dijs-Elsinga

Kemmeren

et al. 2015

BJOG

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Objective This study aims to assess the safety of Influenza A(H1N1), vaccination administered during the second and third trimester and containing MF59 and thiomersal (Focetria â ), measured by pregnancy outcomes and infant's health.Design Cross-sectional linkage study.Setting and sample A sample of pregnant women, eligible for prenatal screening, were invited to participate.Methods Questionnaire data were linked with the Netherlands Perinatal Registry (n = 1920). Information on infant growth, development (n = 1739) and infection-related contacts with the general practitioner (GP) during the first year of life (n = 1671) was obtained.Main outcome measures Multivariate logistic regression was used to assess the association between H1N1 vaccination and small-forgestational-age infant, preterm delivery and a composite adverse outcome, i.e. low Apgar-score, neonatal intensive care unit admission, neonatal resuscitation or perinatal death. Influence of maternal vaccination on growth, development and GP infectionrelated contact rates were assessed using multivariate linear mixed modelling and multivariate negative binomial regression, respectively.Results Response rate was 21%. Though we found differences in characteristics between unvaccinated and vaccinated women, in the multivariate analyses no association was found between H1N1 vaccination and small-for-gestational-age (odds ratio [OR] 0.84; 95% confidence interval [95% CI] 0.50-1.43), preterm delivery (OR 0.98; 95% CI 0.59-1.62) and the composite adverse outcome (OR 0.84; 95% CI 0.44-1.60). We found no differences in weight-for-age (À0.05; 95% CI À0.13 to 0.04), length-for-age (À0.01; 95% CI À0.09 to 0.06), head-circumference-for-age (À0.05; 95% CI À0.13 to 0.03), developmental scores (À0.06; 95% CI À0.28 to 0.17) and infection-related GP contact rates (incidence rate ratio 1.07; 95% CI 0.91-1.28) between infants of unvaccinated and vaccinated mothers.Conclusion Pregnancy outcomes did not differ between H1N1-vaccinated and unvaccinated women. Furthermore, growth, development and GP infection-related contact rates, assessed after the first year of life, were similar in offspring of vaccinated and unvaccinated mothers.Keywords Infant, influenza, pregnancy, safety, vaccination.Tweetable abstract No increased risk for adverse pregnancy outcomes and infant's health following influenza vaccination.Please cite this paper as: van der Maas N, Dijs-Elsinga J, Kemmeren J, van Lier A, Knol M, de Melker H. Safety of vaccination against influenza A (H1N1) during pregnancy in the Netherlands: results on pregnancy outcomes and infant's health: cross-sectional linkage study. BJOG 2016;123:709-717. IntroductionIn spring 2009 an influenza A (H1N1) pandemic occurred. Influenza during pregnancy increases the risk of hospitalisation due to respiratory complications, especially for women with co-morbidity.1-3 Furthermore, during the 2009 pandemic, an increased risk of adverse pregnancy outcomes after infection was reported.4-6 Therefore, the Dutch Health Council advised all pregnant wo...

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“…In addition, these authors recently reported on the risk of fetal death (spontaneous abortion and stillbirth) in the same cohort and found no increased risk after vaccination in pregnancy. 10 These results suggest that this monovalent adjuvanted pandemic vaccine is safe when given during pregnancy.…”

mentioning

confidence: 93%

Influenza Pandemics—Pregnancy, Pathogenesis, and Perinatal Outcomes

Steinhoff¹,

MacDonald

2012

JAMA

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Vaccination against pandemic A/H1N1 2009 influenza in pregnancy and risk of fetal death: cohort study in Denmark

Cited by 116 publications

References 24 publications

Risk of Adverse Fetal Outcomes Following Administration of a Pandemic Influenza A(H1N1) Vaccine During Pregnancy

Risk of Adverse Fetal Outcomes Following Administration of a Pandemic Influenza A(H1N1) Vaccine During Pregnancy

Safety of vaccination against influenza A (H1N1) during pregnancy in the Netherlands: results on pregnancy outcomes and infant's health: cross‐sectional linkage study

Influenza Pandemics—Pregnancy, Pathogenesis, and Perinatal Outcomes

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