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.
诺瓦瓦克斯医药在6月提交了我们2024-2025年配方的COVID-19生物-疫苗（NVX-CoV2705）的美国紧急使用授权申请。我们正在与美国食品和药物管理局（FDA）积极合作，协助他们完成审查，包括根据需要提供额外信息，美国FDA已承诺在监管授权方面迅速行动。我们预计将在疫苗接种高峰期获得授权。
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.
在美国，产品将提供预灌注注射器，获得授权后将在全国数千个地点供应，包括零售商、区域型杂货店和独立药店。
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.
我们2024-2025年配方的COVID-19生物-疫苗针对JN.1，目前流行变种的"母株"，应提供可接受的覆盖范围和交叉反应性，针对JN.1系病毒，包括KP.2.3、KP.3、KP.3.1.1和Lb.1.1。一旦获得授权，诺瓦瓦克斯的疫苗将是美国唯一可用于12岁及以上个体预防COVID-19的基于蛋白质的选择。
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参考文献：
- U.S. Centers for Disease Control and Prevention. Variant Proportions [Data set]. In COVID Data Tracker. 2024. Available at: .