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A(H1N1) vaccination during pregnancy unrelated to increased fetal or birth outcomes
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Vaccination during pregnancy with the MF59 adjuvanted influenza A(H1N1) vaccine does not appear to be related to spontaneous deliveries or fetal outcomes, according to recent findings.
However, a slight increase was observed in the incidence of gestational diabetes and eclampsia, researchers wrote.
In a population-based cohort study, Francesco Trotta, PhD, of the National Institute of Health in Rome, and colleagues used a national birth registry to extract data on all deliveries that took place in the Lombardy region of Italy between Oct. 1, 2009, and Sept. 30, 2010. The women were aged 12 to 55 years, and the deliveries occurred between 23 and 45 weeks of gestation.
Of 86,171 pregnant women, 6,246 received the vaccine; 3,615 were vaccinated in the third trimester and 2,557 were vaccinated in the second trimester.
The study’s primary maternal outcomes were type of delivery, ICU admission, eclampsia and gestational diabetes. Fetal and infant outcomes included perinatal mortality, small-for-gestational-age birth and congenital abnormalities.
The investigators found that vaccinated women demonstrated no differences in spontaneous delivery (adjusted OR=1.02; 95% CI, 0.96-1.08) or in ICU admissions (adjusted OR=0.95; 95% CI, 0.47-1.88). A modest increase was noted among the vaccinated cohort in the incidence of gestational diabetes (adjusted OR=1.26; 95% CI, 1.04-1.53) and eclampsia (adjusted OR=1.19; 95% CI, 1.04-1.39). No significant difference was seen in the rates of fetal and neonatal outcomes between vaccinated and unvaccinated women. There was, however, a small increase in congenital malformations in the vaccinated cohort (adjusted OR=1.14; 95% CI, 0.99-1.31), but this finding was not statistically significant.
According to the researchers, these findings add to the existing knowledge regarding the safety of the vaccine in pregnant women, but further study is still needed. They added that clinicians should weigh the risks of vaccination during pregnancy against the risks of influenza infection during pregnancy.
“Meta-analysis of published studies should be carried out to better define the risk of less frequent outcomes, such as specific congenital malformations. In comparison with the past, future vaccination campaigns targeted at pregnant women will rely on more sound evidence on the safety of vaccine,” the researchers wrote. “Clearly, two other factors — maternal and fetal risks associated with the influenza infection during pregnancy, together with the evidence on the effectiveness of the vaccination — should also be taken into account in decision making.”
Disclosure: The researchers report no relevant financial disclosures.
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