9 October 2024 -Novavax, Inc.  announced that the European Commission granted Marketing Authorization for Novavax's updated 2024-2025 Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2705), dispersion for injection, for use in individuals aged 12 and older for the prevention of COVID-19 in the European Union (EU).

2024年10月9日，Novavax，Inc.宣布，欧盟委员会批准Novavax更新的2024-2025年Nuvaxovid COVID-19疫苗（重组，佐剂）（NVX-CoV2705）的上市许可，该疫苗为注射用分散剂，用于欧盟（EU）12岁及以上的人预防COVID-19。

This decision follows the positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA).

这一决定是根据欧洲药品管理局（EMA）人类使用药品委员会的积极意见作出的。

Authorization was based on non-clinical data that showed Novavax's updated vaccine provides cross-reactivity against JN.1 and numerous JN.1 lineage viruses, including KP.2.3, KP.3, KP.3.1.1 and LB.1. In clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.

授权基于非临床数据，该数据显示Novavax的更新疫苗可对JN.1和许多JN.1谱系病毒（包括KP.2.3，KP.3，KP.3.1.1和LB.1）产生交叉反应。在临床试验中，与Novavax原型COVID-19疫苗（NVX-CoV2373）相关的最常见不良反应包括头痛，恶心或呕吐，肌肉疼痛，关节疼痛，注射部位压痛，注射部位疼痛，疲劳和不适。

Novavax's vaccine is also authorized for use in the U.S., and is in line with guidance from the FDA. Novavax COVID 19 Vaccine Adjuvanted (2024-2025) Formula has not been approved in the US but authorized for Emergency Use to prevent COVID 19 for use in individuals  12 years and older..

Novavax的疫苗也被授权在美国使用，并且符合FDA的指导。Novavax新型冠状病毒19疫苗佐剂（2024-2025）配方尚未在美国获得批准，但已授权紧急使用，以防止新型冠状病毒19在12岁及以上的人群中使用。。

Condition: COVID 19:JN 1 Omnicron

条件：COVID 19:JN 1 Omnicron

Type: drug

类型：药物