Novavax Submits Amendment To FDA For Emergency Use Authorization Of Updated JN.1 COVID-19 Vaccine For Ages 12 And Older; Targets JN.1 Lineage Following Guidance From FDA, EMA, And WHO
Novavax Submits Amendment To FDA For Emergency Use Authorization Of Updated JN.1 COVID-19 Vaccine For Ages 12 And Older; Targets JN.1 Lineage Following Guidance From FDA, EMA, And WHO
诺瓦瓦克斯医药提交修正文件给FDA，以获得针对12岁及以上人群的更新版JN.1 COVID-19生物-疫苗紧急使用授权; 遵循FDA，EMA和WHO的指南，瞄准JN.1血缘。
- Novavax's updated JN.1 COVID-19 vaccine is active against current circulating strains, including KP.2 and KP.3
- Novavax's JN.1 COVID-19 vaccine would be the only protein-based option available in the U.S.
- Novavax's filing is aligned with FDA, EMA and WHO global recommendations on vaccine composition
- Novavax intends to have its vaccine in pre-filled syringes available in the U.S. for immediate release post-authorization and following recommendation by the U.S. CDC
- 诺瓦瓦克斯医药更新的JN.1 COVID-19生物-疫苗针对目前流行的毒株具有活性，包括KP.2和KP.3。
- 诺瓦瓦克斯医药的JN.1 COVID-19生物-疫苗将是美国唯一可用的基于蛋白质的选项。
- 诺瓦瓦克斯医药的申报符合全球货币（FDA、EMA和WHO）对疫苗组成的建议。
- 诺瓦瓦克斯医药打算在获得授权并在美国CDC建议后，提供其预先装有疫苗的针筒以供立即发行。
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