title: Post-licensure safety surveillance for human papillomavirus-16/18-AS04-adjuvanted vaccine: more than 4 years of experience.
abstract: OBJECTIVE
  To summarise post-licensure safety surveillance over more than 4 years of routine use of the human papillomavirus-16/18-AS04-adjuvanted vaccine (HPV-16/18 vaccine: Cervarix®, GlaxoSmithKline, Belgium).
  
  
  METHODS
  We describe global post-licensure passive surveillance data based on routine pharmacovigilance from 18 May 2007 until 17 November 2011 and enhanced surveillance implemented during the 2-year national immunisation programme in the UK (school years 2008-2010).
  
  
  RESULTS
  Spontaneous reports from countries worldwide showed a similar pattern for the most frequently reported adverse events after HPV-16/18 vaccination. No patterns or trends were observed for potential immune-mediated diseases after vaccination. Observed incidences of Bell's palsy and confirmed Guillain-Barré syndrome were within the expected range in the general population. Outcomes of pregnancy in women who were inadvertently exposed to HPV-16/18 vaccine during pregnancy, were in line with published reports for similar populations. Enhanced surveillance of adverse events in the UK triggered a review of cases of anaphylaxis, angioedema and syncope reports, leading to an update to the prescribing information.
  
  
  CONCLUSIONS
  Collaborative partnerships between industry and national regulatory agencies facilitated rapid notification and transfer of safety information, allowing for rapid responses in the event of a safety signal of adverse event of concern. More than 4 years of post-licensure experience may provide confidence to providers and the public about the safety profile of HPV-16/18 vaccine in routine use. The safety profile appears to be consistent with pre-licensure data reporting that HPV-16/18 vaccine has an acceptable benefit-risk profile in adolescent girls and women.
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: Maria-Genalin
authors.initials: MG
authors.lastname: Angelo
authors.forename: Julia
authors.initials: J
authors.lastname: Zima
authors.forename: Fernanda
authors.initials: F
authors.lastname: Tavares Da Silva
authors.forename: Laurence
authors.initials: L
authors.lastname: Baril
authors.forename: Felix
authors.initials: F
authors.lastname: Arellano
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D005260:Female; D006801:Humans; D017589:Immunization Programs; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D011247:Pregnancy; D011358:Product Surveillance, Postmarketing; D014611:Vaccination / Q000009:adverse effects
chemical_list: D000276:Adjuvants, Immunologic; D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18
keywords: AS04; adverse drug reactions; human papillomavirus vaccine; pharmacoepidemiology; post-licensure surveillance; potential immune-mediated diseases; pregnancy