Strategies for continuous evaluation of the benefit–risk profile of HPV-16/18-AS04-adjuvanted vaccine
作者： Maria-Genalin Angelo , Sylvia Taylor , Frank Struyf , Fernanda Tavares Da Silva , Felix Arellano
DOI: 10.1586/14760584.2014.959931
关键词:
摘要: 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 134 countries for the prevention of persistent infection, premalignant lesions caused by oncogenic HPV. Benefit–risk status requires continual re-evaluation as vaccine uptake increases, epidemiology disease evolves new information becomes available. This paper provides an example benefit–risk considerations risk-management planning. Evaluation HPV-16/18-vaccine post-licensure includes studies with a range designs many collaboration national public agencies regulatory authorities. strategy to assess benefit versus risk will continue evolve adapt changing market.
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