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Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy.
JAMA. 2012 Jul 11; 308(2):165-74.JAMA

Abstract

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.

Authors+Show Affiliations

Department of Epidemiology Research, Statens Serum Institut, Artillerivej 5, 2300 Copenhagen S, Denmark. bjp@ssi.dkNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22782418

Citation

Pasternak, Björn, et al. "Risk of Adverse Fetal Outcomes Following Administration of a Pandemic Influenza A(H1N1) Vaccine During Pregnancy." JAMA, vol. 308, no. 2, 2012, pp. 165-74.
Pasternak B, Svanström H, Mølgaard-Nielsen D, et al. Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy. JAMA. 2012;308(2):165-74.
Pasternak, B., Svanström, H., Mølgaard-Nielsen, D., Krause, T. G., Emborg, H. D., Melbye, M., & Hviid, A. (2012). Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy. JAMA, 308(2), 165-74. https://doi.org/10.1001/jama.2012.6131
Pasternak B, et al. Risk of Adverse Fetal Outcomes Following Administration of a Pandemic Influenza A(H1N1) Vaccine During Pregnancy. JAMA. 2012 Jul 11;308(2):165-74. PubMed PMID: 22782418.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy. AU - Pasternak,Björn, AU - Svanström,Henrik, AU - Mølgaard-Nielsen,Ditte, AU - Krause,Tyra G, AU - Emborg,Hanne-Dorthe, AU - Melbye,Mads, AU - Hviid,Anders, PY - 2012/7/12/entrez PY - 2012/7/12/pubmed PY - 2012/7/13/medline SP - 165 EP - 74 JF - JAMA JO - JAMA VL - 308 IS - 2 N2 - 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. SN - 1538-3598 UR - https://www.unboundmedicine.com/medline/citation/22782418/Risk_of_adverse_fetal_outcomes_following_administration_of_a_pandemic_influenza_A_H1N1__vaccine_during_pregnancy_ L2 - https://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.2012.6131 DB - PRIME DP - Unbound Medicine ER -