Stillo Michela, Carrillo Santisteve Paloma, Lopalco Pier Luigi
Department of Public Health and Paediatric sciences, University of Turin.
Expert Opin Drug Saf. 2015 May;14(5):697-712. doi: 10.1517/14740338.2015.1013532. Epub 2015 Feb 18.
Between 2006 and 2009, two different human papillomavirus virus (HPV) vaccines were licensed for use: a quadrivalent (qHPVv) and a bivalent (bHPVv) vaccine. Since 2008, HPV vaccination programmes have been implemented in the majority of the industrialized countries. Since 2013, HPV vaccination has been part of the national programs of 66 countries including almost all countries in North America and Western Europe. Despite all the efforts made by individual countries, coverage rates are lower than expected. Vaccine safety represents one of the main concerns associated with the lack of acceptance of HPV vaccination both in the European Union/European Economic Area and elsewhere.
Safety data published on bivalent and quadrivalent HPV vaccines, both in pre-licensure and post-licensure phase, are reviewed.
Based on the latest scientific evidence, both HPV vaccines seem to be safe. Nevertheless, public concern and rumors about adverse events (AE) represent an important barrier to overcome in order to increase vaccine coverage. Passive surveillance of AEs is an important tool for detecting safety signals, but it should be complemented by activities aimed at assessing the real cause of all suspect AEs. Improved vaccine safety surveillance is the first step for effective communication based on scientific evidence.
2006年至2009年间,两种不同的人乳头瘤病毒(HPV)疫苗获得许可使用:一种四价(qHPVv)疫苗和一种二价(bHPVv)疫苗。自2008年以来,大多数工业化国家已实施HPV疫苗接种计划。自2013年以来,HPV疫苗接种已成为66个国家国家计划的一部分,包括北美和西欧的几乎所有国家。尽管各国都做出了种种努力,但接种率仍低于预期。疫苗安全性是欧盟/欧洲经济区及其他地区HPV疫苗接种率未达预期的主要担忧之一。
对二价和四价HPV疫苗在上市前和上市后阶段公布的安全性数据进行了综述。
根据最新科学证据,两种HPV疫苗似乎都是安全的。然而,公众对不良事件(AE)的担忧和传言是提高疫苗接种率需要克服的重要障碍。对AE的被动监测是检测安全信号的重要工具,但还应辅以旨在评估所有可疑AE真正原因的活动。改进疫苗安全性监测是以科学证据为基础进行有效沟通的第一步。