Novavax Continues to Work With the U.S. FDA on Authorization of 2024-2025 Formula COVID-19 Vaccine
Novavax Continues to Work With the U.S. FDA on Authorization of 2024-2025 Formula COVID-19 Vaccine
Novavax filed for U.S. Emergency Use Authorization of our 2024-2025 formula COVID-19 vaccine (NVX-CoV2705) in June. We are working productively with the U.S. Food and Drug Administration (FDA) as they complete their review, including providing additional information as needed, and the U.S. FDA has committed to moving swiftly on regulatory authorization. We expect to have authorization in time for peak vaccination season.
Novavax 於 6 月申請了我們的 2024-2025 年 COVID-19 配方疫苗（NVX-CoV2705）的美國緊急使用授權。我們正在與美國食品藥品監督管理局（FDA）進行富有成效的合作，包括根據需要提供更多信息，美國食品藥品監督管理局（FDA）已承諾迅速批准監管授權。我們預計將在疫苗接種旺季之前及時獲得授權。
In the U.S., product will be supplied in pre-filled syringes and after authorization, will be available in thousands of locations across the country, including retailers, regional grocers and independent pharmacies.
在美國，產品將以預充注射器形式供應，經批准後，將在全國數千個地點上市，包括零售商、區域雜貨店和獨立藥房。
Our 2024-2025 formula COVID-19 vaccine targets JN.1, the "parent strain" of currently circulating variants and should provide acceptable coverage and cross-reactivity against JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1.1 Upon authorization, Novavax's vaccine will be the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19.
我們的 2024-2025 年 COVID-19 疫苗配方針對 JN.1，即當前流行變種的 「母體菌株」，應提供可接受的覆蓋範圍和交叉反應性，包括 KP.2.3、KP.3、KP.3.1.1 和 Lb.1.1。經授權，Novavax 的疫苗將成爲美國唯一可用於 12 歲及以上人群預防 COVID-19 的蛋白質類選擇。
References:
參考文獻：
- U.S. Centers for Disease Control and Prevention. Variant Proportions [Data set]. In COVID Data Tracker. 2024. Available at: .
- 美國疾病控制與預防中心。變量比例 [數據集]。在 COVID 數據追蹤器中。2024 年。可在以下網址獲得：。