Björn
Pasternak, MD, PhD; Henrik Svanström, MSc; Ditte Mølgaard-Nielsen, MSc;
Tyra G. Krause, MD, PhD; Hanne-Dorthe Emborg, DVM; Mads Melbye, MD,
DrMedSci; Anders Hviid, MSc, DrMedSci.
JAMA. 2012;308(2):165-174.
doi:10.1001/jama.2012.6131 ( acceso a texto completo)
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.
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