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Report from the World Health Organization’s third Product Development for Vaccines Advisory Committee (PDVAC) meeting Geneva 8–10th June 2016

机译:世界卫生组织第三次疫苗产品开发咨询委员会(PDVAC)会议的报告2016年6月8日至10日日内瓦

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摘要

The third meeting of WHO’s Product Development for Vaccines Advisory Committee (PDVAC) was held in June 2016, with a remit to revisit the pathogen areas for which significant progress has occurred since recommendations from the 2015 meeting, as well as to consider new advances in the development of vaccines against other pathogens. Since the previous meeting, significant progress has been made with regulatory approvals of the first malaria and dengue vaccines, and the first phase III trials of a respiratory syncytial virus (RSV) vaccine candidate has started in the elderly and pregnant women. In addition, PDVAC has also supported vaccine development efforts against important emerging pathogens, including Middle Eastern Coronavirus (MERS CoV) and Zika virus. Trials of HIV and tuberculosis vaccine candidates are steadily progressing towards pivotal data points, and the leading norovirus vaccine candidate has entered a phase IIb efficacy study. WHO’s Immunization, Vaccine and Biologicals (IVB) department is actively working in several pathogen areas on the recommendation of PDVAC, as well as continuing horizon scanning for advances in the development of vaccines that may benefit low and middle income countries (LMICs), such as the recent licensure of the enterovirus 71 (EV71) vaccine in China. Following on from discussions with WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization, PDVAC will also look beyond licensure and consider data needs for vaccine recommendation and implementation to reduce the delay between vaccine approval and vaccine impact.
机译:世卫组织疫苗产品开发咨询委员会(PDVAC)于2016年6月举行了第三次会议,其职权范围是重新审查自2015年会议的建议以来已取得重大进展的病原体领域,并考虑该领域的新进展。开发针对其他病原体的疫苗。自上次会议以来,首批疟疾和登革热疫苗的监管批准取得了重大进展,并且呼吸道合胞病毒(RSV)候选疫苗的第一阶段III期试验已在老年人和孕妇中启动。此外,PDVAC还支持针对重要的新兴病原体,包括中东冠状病毒(MERS CoV)和寨卡病毒的疫苗开发工作。 HIV和结核病疫苗候选者的试验正朝着关键数据点稳步发展,主要的诺如病毒疫苗候选者已进入IIb期疗效研究。世卫组织的免疫,疫苗和生物制剂(IVB)部门正在根据PDVAC的建议在多个病原体领域积极开展工作,并持续进行视野扫描,以寻找可能使中低收入国家(LMIC)受益的疫苗开发进展最近在中国获得了肠道病毒71(EV71)疫苗的许可。在与世界卫生组织免疫战略咨询专家组(SAGE)进行讨论之后,PDVAC还将超越许可范围,并考虑疫苗推荐和实施的数据需求,以减少疫苗批准和疫苗影响之间的延迟。

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