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.
8702
评估过程中会权衡突发事件造成的威胁以及使用有关产品可能带来的好处与任何潜在风险。
The assessmentweighs 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.
The WHO prequalification 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.
SAGE is the principal advisory group to WHO for vaccines and immunization.
8709
SAGE不仅关注儿童疫苗和免疫接种，还关注所有疫苗可预防疾病。
It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and immunization technology, research and development, to delivery of immunization and its linkages with other health interventions.
8710
SAGE评估安全性、效力、有效性、影响和实施工作适用性方面的证据，同时考虑对个体和公共卫生的影响。
SAGE assessesevidence on safety, efficacy, effectiveness, impact and programmatic suitability, considering both individual and public health impact.