Novavax Inc. announced that the FDA has approved the Biologics License Application (BLA) for Nuvaxovid for active immunization to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12-64 years who have at least one underlying condition that puts them at high risk for severe outcomes from Covid-19 (e.g.

诺瓦瓦克斯公司宣布，FDA已批准Nuvaxovid的生物制品许可申请（BLA），用于主动免疫以预防由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的2019年冠状病毒病（Covid-19）。该疫苗适用于65岁及以上的成年人，以及12至64岁且至少有一种基础疾病、使其面临高风险出现Covid-19严重后果的人群（例如）。

asthma, cancer, diabetes, obesity, smoking)..

哮喘、癌症、糖尿病、肥胖、吸烟）。

Novavax Inc. announced that the FDA has approved the Biologics License Application (BLA) for Nuvaxovid for active immunization to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12-64 years who have at least one underlying condition that puts them at high risk for severe outcomes from Covid-19 (e.g.

诺瓦瓦克斯公司宣布，FDA已批准Nuvaxovid的生物制品许可申请（BLA），用于主动免疫以预防由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的2019年冠状病毒病（Covid-19）。该疫苗适用于65岁及以上的成年人，以及12至64岁且至少患有一种基础疾病、使其面临较高重症风险的个体（例如）。

asthma, cancer, diabetes, obesity, smoking). Achievement of the U.S. license approval has triggered a $175 million milestone payment from Sanofi..

哮喘、癌症、糖尿病、肥胖、吸烟）。美国许可证批准的达成已触发赛诺菲支付1.75亿美元的里程碑款项。

'The approval solidifies a pathway for Americans aged 65 and older and those aged 12 through 64 with an underlying condition that puts them at high risk for severe outcomes from COVID-19 to have access to a protein-based, non-mRNA COVID-19 vaccine,' said John C. Jacobs, President and Chief Executive Officer, Novavax.

“该批准为65岁及以上的美国人以及12至64岁之间患有使他们面临新冠重症高风险的基础疾病的个人，提供了一种基于蛋白质的非mRNA新冠疫苗的途径，”诺瓦瓦克斯公司总裁兼首席执行官约翰·C·雅各布斯表示。

'Market research and U.S. CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally. This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option.'.

市场研究和美国疾控中心统计数据显示，年龄较大的人群和有基础疾病的人群是最有可能季节性寻求接种新冠疫苗的群体。这一重要里程碑展示了我们对这些人群的承诺，并且是我们基于蛋白质的疫苗选项可用性的重要一步。

The approval triggers a $175 million milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in

根据诺瓦瓦克斯与赛诺菲签署的合作与许可协议，该批准触发了1.75亿美元的里程碑付款。

May 2024

2024年5月

. The agreement has layers of value for Novavax. Sanofi is leading on commercialization efforts starting this year and Novavax is eligible to receive ongoing tiered royalties from stand-alone Covid-19 vaccine sales for all future vaccination seasons.

该协议对诺瓦瓦克斯具有多重价值。从今年开始，赛诺菲将主导商业化工作，而诺瓦瓦克斯将有资格从所有未来疫苗接种季的独立新冠疫苗销售中获得持续的分层特许权使用费。

The BLA approval was based on pivotal Phase III clinical trial data that showed Nuvaxovid was safe and effective for the prevention of Covid-19. In addition, the FDA has requested a new postmarketing commitment (PMC) to conduct a Phase IV prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe Covid-19.

生物制品许可申请（BLA）的批准基于关键的III期临床试验数据，该数据显示Nuvaxovid在预防新冠肺炎方面是安全且有效的。此外，FDA要求一项新的上市后承诺（PMC），即在50至64岁之间无高风险条件导致重症新冠肺炎的人群中，进行一项IV期前瞻性、随机、双盲、安慰剂对照的有效性和安全性试验。

Novavax is working closely with Sanofi to assess funding and execution of this new trial. This PMC supplements previously agreed upon postmarketing requirements and commitments which have been commonly required for Covid-19 vaccine manufacturers..

诺瓦瓦克斯正在与赛诺菲密切合作，以评估这项新试验的资助和执行情况。该PMC补充了此前商定的上市后要求和承诺，这些要求和承诺通常是针对新冠疫苗制造商的常见要求。

Novavax expects to be ready for the commercial delivery of the 2025-2026 Covid-19 vaccine formula in the U.S. this fall (autumn) in partnership with Sanofi, pending strain recommendation at the FDA Vaccines and Related Biological Products Advisory Committee meeting on May 22, 2025.

诺瓦瓦克斯预计，与赛诺菲合作，将在今年秋季（即北半球的秋天）为美国市场准备好2025-2026年新冠疫苗配方的商业交付，但需等待2025年5月22日美国食品药品监督管理局（FDA）疫苗及相关生物制品咨询委员会会议上关于毒株推荐的决定。

Condition:

条件：

Coronavirus/COVID-19 Infection

冠状病毒/COVID-19 感染

Type:

类型：

drug

药物