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)
Assessment of the fetal safety of vaccination against influenza A(H1N1)pdm09 in pregnancy has been limited.
investigate whether exposure to an adjuvanted influenza A(H1N1)pdm09
vaccine during pregnancy was associated with increased risk of adverse
DESIGN, SETTING, AND PARTICIPANTS:
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
MAIN OUTCOME MEASURES:
Major birth defects, preterm birth, and small size for gestational age.
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).
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