World Health Organization, Switzerland.
Bill & Melinda Gates Foundation, USA.
Vaccine. 2022 Sep 29;40(41):5843-5855. doi: 10.1016/j.vaccine.2022.08.020. Epub 2022 Aug 22.
The World Health Organization (WHO) global strategy to eliminate cervical cancer (CxCa) could result in >62 million lives saved by 2120 if strategy targets are reached and maintained: 90% of adolescent girls receiving prophylactic human papillomavirus (HPV) vaccine, 70% of women receiving twice-lifetime cervical cancer screening, and 90% of cervical pre-cancer lesions and invasive CxCa treated. However, the cost and complexity of CxCa screening and treatment approaches has hampered scale-up, particularly in low- and middle-income countries (LMICs), and new approaches are needed. Therapeutic HPV vaccines (TxV), which could clear persistent high-risk HPV infection and/or cause regression of pre-cancerous lesions, are in early clinical development and might offer one such approach. During October 2021 to March 2022, WHO, in collaboration with the Bill and Melinda Gates Foundation, convened a series of global expert consultations to lay the groundwork for understanding the potential value of TxV in the context of current CxCa prevention efforts and for defining WHO preferred product characteristics (PPCs) for TxV. WHO PPCs describe preferences for vaccine attributes that would help optimize vaccine value and use in meeting the global public health need. This paper reports on the main discussion points and findings from the expert consultations. Experts identified several ways in which TxV might address challenges in current CxCa prevention programmes, but emphasized that the potential value of TxV will depend on their degree of efficacy and how quickly they can be developed and implemented relative to ongoing scale-up of existing interventions. Consultation participants also discussed potential use-cases for TxV, important PPC considerations (e.g., vaccine indications, target populations, and delivery strategies), and critical modelling needs for predicting TxV impact and cost-effectiveness.
世界卫生组织（WHO）消除宫颈癌（CxCa）全球战略，如果达到并维持战略目标，到 2120 年可能会挽救超过 6200 万人的生命：90%的青春期少女接种预防性人乳头瘤病毒（HPV）疫苗，70%的妇女接受两次终生宫颈癌筛查，以及 90%的宫颈癌前病变和侵袭性 CxCa 得到治疗。然而，CxCa 筛查和治疗方法的成本和复杂性阻碍了其推广，特别是在中低收入国家（LMICs），需要新的方法。治疗性 HPV 疫苗（TxV）可以清除持续性高危 HPV 感染和/或导致癌前病变消退，目前处于临床开发早期阶段，可能提供一种这样的方法。2021 年 10 月至 2022 年 3 月，世卫组织与比尔及梅琳达·盖茨基金会合作，召集了一系列全球专家协商，为了解 TxV 在当前 CxCa 预防工作背景下的潜在价值以及为 TxV 确定世卫组织首选产品特征（PPCs）奠定基础。世卫组织 PPCs 描述了对疫苗属性的偏好，这些偏好将有助于优化疫苗价值并用于满足全球公共卫生需求。本文报告了专家协商的主要讨论要点和结果。专家们确定了 TxV 可能解决当前 CxCa 预防方案中挑战的几种方法，但强调 TxV 的潜在价值将取决于其疗效以及与现有干预措施的推广相比，它们能够多快得到开发和实施。协商参与者还讨论了 TxV 的潜在用途、重要的 PPC 考虑因素（例如，疫苗适应证、目标人群和交付策略），以及预测 TxV 影响和成本效益的关键建模需求。
