Strategies for continuous evaluation of the benefit–risk profile of HPV-16/18-AS04-adjuvanted vaccine
| Autor: | Sylvia Taylor, Laurence Baril, Dominique Rosillon, Gary Dubin, Maria-Genalin Angelo, Frank Struyf, Fernanda Tavares Da Silva, Felix Arellano, Marie-Pierre David |
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| Rok vydání: | 2014 |
| Předmět: |
medicine.medical_specialty
Immunology Uterine Cervical Neoplasms Disease Human papillomavirus vaccine Risk Assessment Risk profile Continuous evaluation Belgium Drug Discovery Epidemiology Product Surveillance Postmarketing medicine Humans Papillomavirus Vaccines Intensive care medicine Pharmacology Cervical cancer Human papillomavirus 16 Human papillomavirus 18 Hpv types business.industry Papillomavirus Infections medicine.disease Treatment Outcome Molecular Medicine Female business |
| Zdroj: | Expert Review of Vaccines. 13:1297-1306 |
| ISSN: | 1744-8395 1476-0584 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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