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Objective To describe a large study on pregnancy outcome after
vaccination against H1N1 during the 2009/10 pandemic.
Design A cohort study of women vaccinated with Pandemrix
during pregnancy.
Setting The Swedish Medical Birth Register was used for the
analysis. Information on vaccination and pregnancy week when
vaccination was made was obtained from antenatal care
documents.
Population All women who gave birth during 2009 and 2010 in
Sweden.
Methods Characteristics of the vaccinated women and their
delivery outcome were compared with two groups of women:
women without a known vaccination who gave birth in 2009/10
after 1 October 2009, and women who gave birth during 2009
before 1 October. Adjustment was made for year of delivery,
maternal age, parity, smoking habits and body mass index.
Outcome measures Stillbirth, congenital malformations, preterm
birth, low birthweight, small for gestational age.
Results A total of 18 612 vaccinated women having 18 844 infants
were studied. The risk for stillbirth, preterm birth and low
birthweight was lower than in the comparison groups whereas the
risk for small for gestational age and a congenital malformation
(after vaccination during the first trimester) did not differ from
the comparison groups. No clear-cut explanation to the
‘protective’ effect of vaccination was found.
Conclusions Vaccination during pregnancy with Pandemrix
appeared to have no ill effects on the pregnancy. On the contrary,
the rate of preterm birth and low birthweight was lower than
expected, which agrees with some previous results.
Keywords Congenital malformations, H1N1 influenza vaccination,
pregnancy, preterm birth, small-for-date, stillbirth.
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