title: Strategies for continuous evaluation of the benefit-risk profile of HPV-16/18-AS04-adjuvanted vaccine.
abstract: The HPV types 16/18-AS04-adjuvanted cervical cancer vaccine, Cervarix(®) (HPV-16/18-vaccine, GlaxoSmithKline, Belgium) was first approved in 2007 and is licensed in 134 countries for the prevention of persistent infection, premalignant cervical lesions and cervical cancer caused by oncogenic HPV. Benefit-risk status requires continual re-evaluation as vaccine uptake increases, as the epidemiology of the disease evolves and as new information becomes available. This paper provides an example of benefit-risk considerations and risk-management planning. Evaluation of the benefit-risk of HPV-16/18-vaccine post-licensure includes studies with a range of designs in many countries and in collaboration with national public agencies and regulatory authorities. The strategy to assess benefit versus risk will continue to evolve and adapt to the changing HPV-16/18-vaccine market.
authors.affiliation: GSK Vaccines, Safety Evaluation and Risk Management, Biologicals Clinical Safety and Pharmacovigilance, 20 Avenue Fleming (B23), Wavre, B-1300 Belgium.
authors.forename: Maria-Genalin
authors.initials: MG
authors.lastname: Angelo
authors.forename: Sylvia
authors.initials: S
authors.lastname: Taylor
authors.forename: Frank
authors.initials: F
authors.lastname: Struyf
authors.forename: Fernanda
authors.initials: F
authors.lastname: Tavares Da Silva
authors.forename: Felix
authors.initials: F
authors.lastname: Arellano
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: David
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
authors.forename: Dominique
authors.initials: D
authors.lastname: Rosillon
authors.forename: Laurence
authors.initials: L
authors.lastname: Baril
mesh_terms: D001530:Belgium / Q000453:epidemiology; D005260:Female; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D030361:Papillomavirus Infections / Q000150:complications / Q000453:epidemiology / Q000517:prevention & control / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D011358:Product Surveillance, Postmarketing / Q000379:methods; D018570:Risk Assessment / Q000379:methods*; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology* / Q000517:prevention & control* / Q000821:virology
chemical_list: D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18
keywords: AS04; human papillomavirus vaccine; post-licensure surveillance; potential immune-mediated diseases; pregnancy; safety; vaccine effectiveness; vaccine impact