title: Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study.
abstract: OBJECTIVE
  The 2009-2010 A/H1N1 pandemic provided a unique setting to study the safety of MF59-adjuvanted vaccination in pregnancy.
  
  
  METHODS
  This was an observational cohort study of the safety of an MF59-adjuvanted A/H1N1 vaccine (Focetria) conducted among 4508 pregnant women (2295 vaccinated vs 2213 unvaccinated), with 3 month follow-up of neonates.
  
  
  RESULTS
  No maternal deaths or abortions occurred among the vaccinated women. No differences between the vaccinated and unvaccinated cohorts were observed for gestational diabetes, preeclampsia, stillbirth, low birthweight, neonatal deaths, or congenital malformations. The risk of premature birth was significantly decreased among the vaccinated women (adjusted proportional hazard, 0.69; 95% confidence interval, 0.51-0.92). No differences were observed in rates of congenital malformations after vaccination in the first (2.1%), second (2.7%), or third (2.1%) trimesters.
  
  
  CONCLUSIONS
  There was no evidence of a safety risk for MF59-adjuvanted A/H1N1 vaccination in pregnant women; protection was observed against premature birth.
authors.affiliation: Department of Pediatrics, University of Turku, Turku, Finland.
authors.forename: Terho
authors.initials: T
authors.lastname: Heikkinen
authors.forename: James
authors.initials: J
authors.lastname: Young
authors.forename: Erik
authors.initials: E
authors.lastname: van Beek
authors.forename: Henk
authors.initials: H
authors.lastname: Franke
authors.forename: Thomas
authors.initials: T
authors.lastname: Verstraeten
authors.forename: John G
authors.initials: JG
authors.lastname: Weil
authors.forename: Giovanni
authors.initials: G
authors.lastname: Della Cioppa
mesh_terms: D000276:Adjuvants, Immunologic / Q000009:adverse effects*; D000293:Adolescent; D000328:Adult; D015331:Cohort Studies; D005260:Female; D006801:Humans; D007252:Influenza Vaccines / Q000009:adverse effects*; D007251:Influenza, Human / Q000517:prevention & control*; D008875:Middle Aged; D011136:Polysorbates / Q000009:adverse effects*; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000517:prevention & control*; D013185:Squalene / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D007252:Influenza Vaccines; C089950:MF59 oil emulsion; D011136:Polysorbates; C558220:focetria; D013185:Squalene