AMA与EMA发布埃博拉疫苗开发联合指导文件
正文 · 中文译文
EMA 的紧急任务工作组（ETF）与非洲药品管理局（AMA）发布了一份联合立场文件，以支持针对本迪布焦病毒（BDBV）所致埃博拉病的潜在疫苗及时启动临床试验。该文件是在 AMA、EMA 和世界卫生组织（WHO）于 2026 年 8 月 24 日主办的相关专家科学磋商后制定的。鉴于刚果民主共和国（DRC）正在持续的突发公共卫生事件，且在乌干达、肯尼亚和尼日利亚也发现了病例，BDBV 疫苗候选产品应尽可能快地推进各临床试验阶段。同时，必须保持严格的科学评价，并为临床研究受试者（包括脆弱群体）提供充分保障。该立场文件概述了启动临床试验的最低要求，并就试验设计提供了建议。文件还鼓励非洲国家监管机构（NRAs）及时批准这些试验，以加速专门针对 BDBV 的疫苗研发。该文件说明了在何种情况下，对于具有充分表征的平台数据（如 mRNA 和某些病毒载体疫苗）的疫苗，科学上可以合理地推迟或豁免某些动物毒性研究。如果已有使用同一平台技术的其他疫苗的安全性数据，尤其是当不同抗原未影响总体安全性特征时，此类研究也可能被推迟或豁免。 理想情况下，早期试验应在非洲地区开展，以尽可能高效地过渡到在受影响人群中进行的更大规模疗效试验。应进行非人挑战研究，以确保疫苗在进入II/III期临床试验之前具有有效的可能性。单剂次疫苗更受青睐，因为在疫情期间更易于快速部署。 为评估疫苗接种是否能预防疾病，本立场文件提出一项平台性关键研究（III期），基于将确诊患者的密切接触者纳入并随机分组（环围试验）作为有效方法。多种候选疫苗有可能在同一试验中进行评估。由于BDBV引起的疾病也影响儿童和孕妇，一旦获得足够的成人初步安全性数据，就应开始在这些人群中开展研究。 疫苗开发者应尽早与监管机构接洽，包括AMA和非洲相关国家监管机构，以获得科学和监管建议，促进临床试验评估，并确保满足有前景疫苗潜在授权的监管要求。 关于本迪布焦疫苗临床开发的立场文件 电话：+31 (0)88 781 8427 电子邮箱：press@ema.europa.eu
正文 · 英文原文
EMA’s Emergency Task Force (ETF) and the African Medicines Agency (AMA) have published a joint position paper to support the timely start of clinical trials for potential vaccines against Ebola disease caused by Bundibugyo virus (BDBV). The paper was developed following a scientific consultation with relevant experts, hosted by AMA, EMA and the World Health Organization (WHO) on 24 August 2026. Given the ongoing public health emergency in the Democratic Republic of the Congo (DRC), with cases also detected in Uganda, Kenya and Nigeria, candidates for BDBV vaccines should move through the different clinical trial phases as quickly as possible. At the same time, rigorous scientific evaluation and sufficient safeguards for participants in clinical research, including vulnerable groups, must be maintained. The position paper outlines the minimum requirements to start clinical trials and provides advice on trial design. It also encourages timely approval of these trials by African national regulatory authorities (NRAs) to accelerate the development of vaccines specifically targeting BDBV. The paper explains when it may be scientifically justified to postpone or waive certain animal toxicity studies for vaccines with well-characterised platform data, such as mRNA and certain viral-vector vaccines. Such studies might also be postponed or waived where there is existing safety data from other vaccines using the same platform technology, particularly where different antigens have not affected the overall safety profile. Ideally, early trials should be conducted in the African region to make the transition to larger efficacy trials in affected populations as efficient as possible. Non-human challenge studies should be performed to make sure that vaccines have a chance of being effective before they progress to Phase II/III clinical trials. A single-dose vaccine is preferred as it would be easier to deploy rapidly during an outbreak. To assess whether vaccination prevents disease, the position paper proposes a platform pivotal study (Phase III) based on inclusion and randomisation of people who have been in close contact with a confirmed case (ring trial) as a valid approach. Multiple vaccine candidates could potentially be evaluated in the same trial. As disease caused by BDBV also affects children and pregnant women, studies in these groups should begin once sufficient initial safety data from adults is available. Vaccine developers should engage early with regulators, including AMA and the relevant National Regulatory Authorities in Africa to obtain scientific and regulatory advice, facilitate clinical trial assessments and ensure that regulatory requirements are met for the potential authorisation of promising vaccines. Position paper on clinical development of Bundibugyo vaccines Tel. +31 (0)88 781 8427 E-mail: press@ema.europa.eu