Maure Clara, Khazhidinov Kanat, Kang Hyolim, Auzenbergs Megan, Moyersoen Pascaline, Abbas Kaja, Santos Gustavo Mendes Lima, Medina Libia Milena Hernandez, Wartel T Anh, Kim Jerome H, Clemens John, Sahastrabuddhe Sushant
International Vaccine Institute, South Korea.
Medical Education and Research Alliance, Kazakhstan.
Vaccine. 2024 Dec 2;42(26):126483. doi: 10.1016/j.vaccine.2024.126483. Epub 2024 Oct 29.
Chikungunya is a neglected tropical disease of growing public health concern with outbreaks in more than 114 countries in Asia, Africa, Americas, Europe, and Oceania since 2004. There are no specific antiviral treatment options for chikungunya virus infection. This article describes the chikungunya vaccine pipeline and assesses the challenges in the path to licensure, access, and uptake of chikungunya vaccines in populations at risk. Ixchiq (VLA1533/Ixchiq - Valneva) was the first licensed chikungunya vaccine by the US Food and Drug Administration in November 2023, European Medicines Agency in May 2024, and Health Canada in June 2024. Five chikungunya vaccine candidates (BBV87 - BBIL/IVI, MV-CHIK - Themis Bioscience, ChAdOx1 Chik - University of Oxford, PXVX0317 / VRC-CHKVLP059-00-VP - Bavarian Nordic, and mRNA-1388 - Moderna) are in development. Evidence on chikungunya disease burden alongside the public health and economic impact of vaccination are critical for decision-making on chikungunya vaccine introduction in endemic and epidemic settings. Further, global and regional stakeholders need to agree on a sustainable financing mechanism for manufacturing at scale to facilitate fair access and equitable vaccine distribution to at-risk populations in different geographic settings. This could partly be facilitated through obtaining consensus on scientific and regulatory principles for initial vaccine introduction and generating evidence on chikungunya burden and disease awareness among populations at risk. Specifically, this article advocates for the formation of a global chikungunya vaccine consortium that includes regulators, policymakers, sponsors, and manufacturers to assist in overcoming the global and local challenges for chikungunya vaccine licensure, policy, financing, demand generation, and access to at-risk populations.
基孔肯雅热是一种被忽视的热带疾病,日益引起公众对健康的关注,自2004年以来,亚洲、非洲、美洲、欧洲和大洋洲的114多个国家都爆发了疫情。目前尚无针对基孔肯雅病毒感染的特异性抗病毒治疗方案。本文介绍了基孔肯雅疫苗的研发进展,并评估了在高危人群中批准、获取和使用基孔肯雅疫苗过程中面临的挑战。Ixchiq(VLA1533/Ixchiq - Valneva)是2023年11月美国食品药品监督管理局、2024年5月欧洲药品管理局和2024年6月加拿大卫生部批准的首款基孔肯雅疫苗。有五种基孔肯雅候选疫苗(BBV87 - BBIL/IVI、MV-CHIK - Themis Bioscience、ChAdOx1 Chik - 牛津大学、PXVX0317 / VRC-CHKVLP059-00-VP - 巴伐利亚北欧公司和mRNA-1388 - 莫德纳公司)正在研发中。关于基孔肯雅疾病负担以及疫苗接种对公共卫生和经济影响的证据,对于在地方病和流行地区引入基孔肯雅疫苗的决策至关重要。此外,全球和区域利益相关者需要就大规模生产的可持续融资机制达成一致,以促进公平获取并向不同地理区域的高危人群公平分配疫苗。这可以通过就初始疫苗引入的科学和监管原则达成共识,并收集高危人群中基孔肯雅负担和疾病认知的证据来部分实现。具体而言,本文主张成立一个全球基孔肯雅疫苗联盟,成员包括监管机构、政策制定者、赞助商和制造商,以协助克服基孔肯雅疫苗在全球和地方层面面临的许可、政策、融资、需求生成以及高危人群获取等方面的挑战。