The University of Sydney, Sydney, NSW, Australia.
National Centre for Immunisation Research and Surveillance, Kids Research Institute, The Sydney Children's Hospitals Network, Cnr Hawkesbury Road and Hainsworth Street, Westmead, NSW, 2145, Australia.
Drug Saf. 2018 Apr;41(4):329-346. doi: 10.1007/s40264-017-0625-z.
Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and quadrivalent (4vHPV) vaccines. A nonavalent (9vHPV) vaccine is now available and HPV immunisation programmes have been extended to males in 11 countries. The aim of this updated narrative review was to examine the evidence on HPV vaccine safety, focusing on the 9vHPV vaccine, special populations and adverse events of special interest (AESI). The previous searches were replicated to identify studies to August 2016, including additional search terms for AESI. We identified 109 studies, including 15 population-based studies in over 2.5 million vaccinated individuals across six countries. All vaccines demonstrated an acceptable safety profile; injection-site reactions were slightly more common for 9vHPV vaccine than for 4vHPV vaccine. There was no consistent evidence of an increased risk of any AESI, including demyelinating syndromes or neurological conditions such as complex regional pain or postural orthostatic tachycardia syndromes. The risk-benefit profile for HPV vaccines remains highly favourable.
人乳头瘤病毒(HPV)疫苗现已纳入 71 个国家的免疫计划。不幸的是,由于对 HPV 疫苗安全性的信心降低,一些国家的疫苗接种率受到了影响。2013 年,我们发表了一篇广泛的综述,证明了二价(2vHPV)和四价(4vHPV)疫苗具有令人安心的安全性。目前已有九价(9vHPV)疫苗上市,11 个国家已将 HPV 免疫接种计划扩展至男性。本更新叙述性综述的目的是检查 HPV 疫苗安全性方面的证据,重点关注九价 HPV 疫苗、特殊人群和特殊关注的不良事件(AESI)。复制了之前的搜索以确定截至 2016 年 8 月的研究,包括 AESI 的附加搜索词。我们确定了 109 项研究,其中包括来自六个国家的超过 250 万接种个体的 15 项基于人群的研究。所有疫苗均表现出可接受的安全性;九价 HPV 疫苗比四价 HPV 疫苗更常出现注射部位反应。没有一致证据表明 AESI 的风险增加,包括脱髓鞘综合征或神经疾病,如复杂区域疼痛或姿势性心动过速综合征。HPV 疫苗的风险效益比仍然非常有利。
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