It was found by the SAGE to have an efficacy of efficacy of 94.1%, based on a median follow-up of two months.
6522
该疫苗以 摄氏–25度 至 –15度冷冻悬浮剂形式存于多剂量小瓶。
Although the vaccine is provided as a frozen suspension at –25 ºC to –15 ºC in a multidose vial, vials can be stored refrigerated at 2–8 °C for up to 30 days prior to withdrawal of the first dose, meaning that ultra-cold chain equipment may not always be necessary to deploy the vaccine.
6523
世卫组织紧急使用列表
WHOemergency uselisting
6524
紧急使用列表程序用于评估在突发公共卫生事件中新卫生产品的适用性。
The emergency use listing procedure assesses the suitability of novel health products during public health emergencies.
6525
目标是尽快提供药物、疫苗和诊断工具，以应对突发事件，同时遵守严格的安全性、有效性和质量标准。
The objective is to make medicines, vaccines and diagnostics available as rapidly as possible to address the emergency, while adhering to stringent criteria of safety, efficacy and quality.
6526
评估过程中会权衡突发事件造成的威胁以及使用该产品可能带来的好处与任何潜在风险。
The assessment weighs the threat posed by the emergency as well as the benefit that would accrue from the use of the product against any potential risks.
The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan.
These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.
As part of the EUL process, the company producing the vaccine must commit to continue to generate data to enable full licensure and WHO prequalification of the vaccine.
The WHOprequalification process will assess additional clinical data generated from vaccine trials and deployment on a rolling basis to ensure the vaccine meets the necessary standards of quality, safety and efficacy for broader availability.