Novavax, Inc.  today announced that the U.S. Food and Drug Administration (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 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g.

Novavax, Inc. 今天宣布，美国食品药品监督管理局（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岁之间至少有一种基础疾病、使其面临COVID-19严重后果高风险的个体（例如）。

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

哮喘、癌症、糖尿病、肥胖、吸烟）。

Achievement of the U.S. license approval has triggered a

美国许可证批准的达成已经触发了

$175 million

1.75亿美元

milestone payment from Sanofi.

来自赛诺菲的里程碑付款。

'Today's 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

“今天的批准为65岁及以上的美国人以及12至64岁有基础疾病、面临新冠重症高风险的人群提供了使用基于蛋白质的非mRNA新冠疫苗的机会，”

John C. Jacobs

约翰·C·雅各布斯

, President and Chief Executive Officer, Novavax. '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.'.

，总裁兼首席执行官，诺瓦瓦克斯。“市场研究和美国疾病控制与预防中心（CDC）的统计数据表明，年长者和有基础疾病的人群是最有可能季节性寻求新冠疫苗接种的群体。这一重要里程碑展示了我们对该人群的承诺，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

批准触发了

$175 million

1.75亿美元

milestone payment under the collaboration and license agreement between Novavax and Sanofi signed in

根据Novavax和Sanofi签署的合作与许可协议中的里程碑付款

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，诺瓦瓦克斯有资格从所有未来疫苗接种季节的独立COVID-19疫苗销售中获得持续的分级特许权使用费。

The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19.

基于关键的第三阶段临床试验数据，BLA批准显示Nuvaxovid对预防新冠肺炎是安全有效的。

In addition, the FDA has requested a new postmarketing commitment (PMC) to conduct a Phase 4 prospective, randomized, double-blinded, placebo-controlled efficacy and safety trial in individuals aged 50 through 64 without high-risk conditions for severe COVID-19. Novavax is working closely with Sanofi to assess funding and execution of this new trial.

此外，FDA 已要求作出新的上市后承诺 (PMC)，以在 50 至 64 岁且无严重 COVID-19 高风险状况的个体中开展第四阶段前瞻性、随机、双盲、安慰剂对照的有效性和安全性试验。Novavax 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。

This PMC supplements previously agreed upon postmarketing requirements and commitments which have been commonly required for COVID-19 vaccine manufacturers..

本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COVID-19疫苗制造商的。

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

诺瓦瓦克斯预计今年秋季将与赛诺菲合作，准备好在美国推出2025-2026年新冠疫苗配方，等待FDA疫苗及相关生物制品咨询委员会会议上的毒株推荐。

Nuvaxovid is a vaccine indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Nuvaxovid 是一种疫苗，用于主动免疫以预防由 SARS-CoV-2 引起的 COVID-19，适用于 65 岁及以上的成年人，以及 12 至 64 岁之间至少有一种基础疾病使其面临较高严重后果风险的个体。

About Nuvaxovid

关于Nuvaxovid

Nuvaxovid (NVX-CoV2705) is an updated version of Novavax's prototype COVID-19 vaccine (NVX-CoV2373) formulated to target the JN.1 variant. It is a protein-based vaccine made by creating copies of the surface spike protein of SARS-CoV-2 that causes COVID-19. With Novavax's unique recombinant nanoparticle technology, the non-infectious spike protein serves as the antigen that primes the immune system to recognize the virus, while Novavax's Matrix-M.

Nuvaxovid（NVX-CoV2705）是诺瓦瓦克斯公司对其原始新冠疫苗（NVX-CoV2373）的更新版本，专门针对JN.1变异株。这是一种基于蛋白质的疫苗，通过复制导致新冠的SARS-CoV-2病毒表面刺突蛋白制成。利用诺瓦瓦克斯独特的重组纳米颗粒技术，这种非感染性的刺突蛋白作为抗原，激发免疫系统识别病毒，同时结合诺瓦瓦克斯的Matrix-M佐剂。

adjuvant enhances and broadens the immune response. The vaccine is packaged as a ready-to-use liquid formulation and is stored at 2° to 8°C, enabling the use of existing vaccine supply and cold chain channels.

佐剂增强并拓宽了免疫反应。该疫苗为即用型液体配方，储存温度为2°至8°C，可利用现有的疫苗供应和冷链渠道。

About Matrix-M

关于Matrix-M

Matrix-M is Novavax's proprietary adjuvant that can be added to a vaccine or medicine to stimulate a stronger immune response and is currently used in globally approved vaccines. It is clinically proven to induce potent, durable and broad immune responses with an acceptable safety and tolerability profile and allows use of a lower dose of antigen that is still effective..

Matrix-M 是诺瓦瓦克斯（Novavax）的 proprietary 佐剂，可以添加到疫苗或药物中以刺激更强的免疫反应，目前已被用于全球批准的疫苗中。临床证明，它能够诱导出强大、持久且广泛的免疫反应，具有可接受的安全性和耐受性，并允许使用较低剂量但仍有效的抗原。

Matrix-M is sustainably harvested and manufactured and has the potential to enhance existing and new vaccines. When combined with the Company's recombinant, protein-based nanoparticles, this technology platform is the basis of Novavax's expanding pipeline.

Matrix-M 以可持续的方式进行采集和生产，有潜力增强现有及新疫苗的效果。当与公司的重组蛋白纳米颗粒结合时，该技术平台成为 Novavax 不断扩展的产品线的基础。

About Novavax

关于诺瓦瓦克斯

Novavax, Inc. (Nasdaq:) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies.

Novavax, Inc. (Nasdaq:）利用其在疫苗方面的科学专长及其经过验证的技术平台应对一些全球最紧迫的健康挑战，该平台包括基于蛋白质的纳米颗粒及其Matrix-M佐剂。公司的增长战略旨在优化现有合作伙伴关系，并通过研发创新、在传染病及其他领域进行有机产品组合扩展，以及与其他公司建立新的合作伙伴关系和协作，来扩大对其经过验证的技术平台的使用。