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
諾瓦瓦克斯醫藥提交修正文件給FDA，以獲得針對12歲及以上人群的更新版JN.1 COVID-19生物-疫苗緊急使用授權; 遵循FDA，EMA和WHO的指南，瞄準JN.1血緣。
- 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
- 諾瓦瓦克斯醫藥更新的JN.1 COVID-19生物-疫苗針對目前流行的毒株具有活性，包括KP.2和KP.3。
- 諾瓦瓦克斯醫藥的JN.1 COVID-19生物-疫苗將是美國唯一可用的基於蛋白質的選項。
- 諾瓦瓦克斯醫藥的申報符合全球貨幣（FDA、EMA和WHO）對疫苗組成的建議。
- 諾瓦瓦克斯醫藥打算在獲得授權並在美國CDC建議後，提供其預先裝有疫苗的針筒以供立即發行。