WHO’s Emergency Use Listing (EUL) assesses the quality, safety and efficacy of COVID-19 vaccines and is a prerequisite for COVAX Facilityvaccine supply.
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该程序还有助于各国加快对引进和接种COVID-19疫苗的监管审批。
It also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
The vaccine has already been reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which makes recommendations for vaccines’ use in populations (i.e.
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专家组在2021年1月25日的临时建议中建议为所有18岁及以上的年龄组接种此疫苗。
recommended age groups, intervals between shots, advice for specific groups such as pregnant and lactating women).
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The SAGE recommended the vaccine for all age groups 18 and above in its interim recommendations dated 25 January 2021.
The USFood and Drug Administration issued an emergency use authorization for the Moderna vaccine on 18 December 2020 and a marketing authorisation valid throughout the European Union was granted by the European Medicines Agency on 6 January 2021.
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如果疫苗开发商能及时提交世卫组织要求的全部数据,世卫组织紧急使用列表程序便可迅速进行。
The WHO EUL process can be carried out quickly when vaccine developers submit the full data required by WHO in a timely manner.
Once those data are submitted, WHO can rapidly assemble its evaluation team and regulators from around the world to assess the information and, when necessary, carry out inspections of manufacturing sites.