title: Risk of solid organ transplant rejection following vaccination with seasonal trivalent inactivated influenza vaccines in England: A self-controlled case-series.
abstract: Annual seasonal influenza vaccination is recommended for transplant recipients. No formal pharmacoepidemiology study has been published on the association between solid organ transplant (SOT) rejection and vaccination with seasonal trivalent inactivated influenza vaccines (TIIVs).
  
  
  
  The risk of SOT (liver, kidney, lung, heart or pancreas) rejection after TIIV vaccination was assessed using a self-controlled case-series method (NCT01715792). SOT recipients in England with transplant rejection were selected from the Clinical Practice Research Datalink and linked Hospital Episode Statistics inpatient data. The study period (September 2006 to August 2009) encompassed three consecutive influenza seasons. We calculated the relative incidence (RI) of SOT rejection between the 30- and 60-day post-vaccination risk periods and the control periods (any follow-up period excluding risk periods), using a Poisson regression model.
  
  
  
  In seasons 2006/07, 2007/08, 2008/09 and pooled seasons, 132, 136, 168 and 375 subjects, respectively, experienced at least one transplant rejection; approximately half (45%-51%) of these subjects had received a TIIV. For season 2006/07, the RI of rejection of any organ, adjusted for time since transplantation, was 0.74 (95% CI: 0.24-2.28) and 0.58 (95% CI: 0.24-1.38) during the 30-day and 60-day risk periods, respectively. Corresponding RIs for season 2007/08 were 1.21 (95% CI: 0.55-2.64) and 1.31 (95% CI: 0.69-2.48); for season 2008/09, 0.99 (95% CI: 0.43-2.28) and 0.64 (95% CI: 0.31-1.33); and for pooled seasons 1.01 (95% CI: 0.58-1.76) and 0.88 (95% CI: 0.56-1.38). The results of a separate analysis of kidney rejections and analyses that took into account additional potential confounders were consistent with those of the main analyses, with 95% CIs including 1 and upper limits below 3.
  
  
  
  This study provides reassuring evidence of the safety profile of TIIVs in SOT recipients, thus supporting current recommendations to vaccinate this risk group annually.
authors.affiliation: Business & Decision Life Sciences (C/O GSK Vaccines), Rue Saint Lambert 141, B-1200 Brussels, Belgium. Electronic address: gael.x.dos-santos@gsk.com.
authors.forename: Gaël
authors.initials: G
authors.lastname: Dos Santos
authors.affiliation: GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium. Electronic address: francois.f.haguinet@gsk.com.
authors.forename: François
authors.initials: F
authors.lastname: Haguinet
authors.affiliation: GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium. Electronic address: catherine.x.cohet@gsk.com.
authors.forename: Catherine
authors.initials: C
authors.lastname: Cohet
authors.affiliation: GSK R&D, Stockley Park West, Uxbridge, Middlesex UB11 1BT, United Kingdom. Electronic address: david.j.webb@gsk.com.
authors.forename: Dave
authors.initials: D
authors.lastname: Webb
authors.affiliation: GSK R&D, Stockley Park West, Uxbridge, Middlesex UB11 1BT, United Kingdom. Electronic address: john.w.logie@gsk.com.
authors.forename: John
authors.initials: J
authors.lastname: Logie
authors.affiliation: GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium. Electronic address: germano.ferreira@p-95.com.
authors.forename: Germano L C
authors.initials: GL
authors.lastname: Ferreira
authors.affiliation: GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium. Electronic address: dominique.x.rosillon@gsk.com.
authors.forename: Dominique
authors.initials: D
authors.lastname: Rosillon
authors.affiliation: GSK Vaccines, Avenue Fleming 20, B-1300 Wavre, Belgium. Electronic address: vivekshinde2020@gmail.com.
authors.forename: Vivek
authors.initials: V
authors.lastname: Shinde
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D004739:England; D005260:Female; D006084:Graft Rejection / Q000453:epidemiology*; D006801:Humans; D007223:Infant; D007252:Influenza Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D007251:Influenza, Human / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D018570:Risk Assessment; D066027:Transplant Recipients; D014611:Vaccination / Q000009:adverse effects*; D055815:Young Adult
chemical_list: D007252:Influenza Vaccines; C556153:pandemrix
keywords: Influenza; Pharmacoepidemiology; Safety; Self-controlled case-series; Transplant rejection; Vaccine