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First Doses of R21/Matrix-M Malaria Vaccine Shipped to Africa

First Doses of R21/Matrix-M Malaria Vaccine Shipped to Africa

第一剂R21/Matrix-M疟疾疫苗运往非洲
诺瓦瓦克斯医药 ·  05/20 00:00
  • Distribution of R21/Matrix-MTM across the African region is expected to begin in coming weeks

  • Serum Institute of India, Novavax and University of Oxford mark achievement during event with Hon. Eric Garcetti, U.S. Ambassador to India, in Pune, India

  • R21/矩阵-M 的分布TM 预计将在未来几周内开始在整个非洲地区展开

  • 印度血清研究所、Novavax和牛津大学在印度浦那与美国驻印度大使埃里克·加塞蒂阁下举行的活动中纪念所取得的成就

GAITHERSBURG, Md., May 20, 2024 – Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant today celebrated the first shipment of R21/Matrix-M malaria vaccine by its partner, Serum Institute of India (SII). R21/Matrix-M is the second malaria vaccine to be authorized for use in children in malaria-endemic regions and is expected to help close the gap between demand and available doses. Distribution to African countries with a high incidence of malaria is expected to begin over the coming weeks.

马里兰州盖瑟斯堡,2024年5月20日——Novavax, Inc.(纳斯达克股票代码:NVAX)是一家使用其Matrix-M佐剂推进蛋白质疫苗的跨国公司,今天庆祝其合作伙伴印度血清研究所(SII)首批发货R21/Matrix-M疟疾疫苗。R21/Matrix-M是第二种获准用于疟疾流行地区儿童的疟疾疫苗,预计将有助于缩小需求与可用剂量之间的差距。预计将在未来几周内开始向疟疾发病率高的非洲国家分发。

"The R21/Matrix-M vaccine is a vital new tool to help stop the devastating health and economic impact of malaria on nearly half of the world's population, including the tragic loss of 1,300 children every single day," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Now more than ever, collaborations are imperative to address unmet needs in preventable infectious disease. Novavax is proud of our partnership with the University of Oxford and Serum Institute of India, and the role of Matrix-M adjuvant in this vaccine, and grateful for the support of Gavi and UNICEF in its rollout."

Novavax总裁兼首席执行官约翰·雅各布斯表示:“R21/Matrix-M疫苗是一个重要的新工具,可以帮助阻止疟疾对世界近一半人口的健康和经济造成毁灭性影响,包括每天有1300名儿童不幸丧生。”“现在,合作比以往任何时候都更加重要,以解决可预防传染病领域未得到满足的需求。Novavax为我们与牛津大学和印度血清研究所的合作以及Matrix-M佐剂在该疫苗中的作用感到自豪,并感谢全球疫苗免疫联盟和联合国儿童基金会对该疫苗的推出的支持。”

The shipment was announced during a ceremony held at SII's headquarters in Pune, India, and attended by the Hon. Eric Garcetti, U.S. Ambassador to India; Mr. Adar Poonawalla, CEO, SII; Dr. Mehreen Datoo, Associate Fellow, Clinical Lecturer in Infectious Diseases, Nuffield Department of Medicine University of Oxford; Silvia Taylor, EVP, Chief Corporate Affairs & Advocacy Officer, Novavax and other dignitaries.

这批货物是在印度浦那SII总部举行的仪式上宣布的,出席仪式的有美国驻印度大使埃里克·加塞蒂阁下;SII首席执行官阿达尔·波纳瓦拉先生;牛津大学纳菲尔德医学院传染病临床讲师副研究员梅琳·达图博士;Novavax执行副总裁、首席企业事务和宣传官西尔维亚·泰勒和其他知名人士白羊座。

Dr. Umesh Shaligram, Executive Director, R&D, Serum Institute of India said, "The commencement of the R21/Matrix-M Malaria Vaccine distribution to Africa represents a groundbreaking advancement in our mission to combat health inequalities worldwide. At the Serum Institute of India, we are incredibly proud to collaborate with our esteemed partners, Novavax and the University of Oxford, as well as Gavi, UNICEF, and the WHO, to make this life-saving vaccine accessible and affordable to those who need it most. Malaria has long been a formidable adversary, claiming countless lives and disproportionately affecting the most vulnerable populations in Africa. By delivering this vaccine to the frontlines, we are not only protecting individuals but also empowering communities and paving the way for a brighter, malaria-free future."

印度血清研究所研发执行董事乌梅什·沙利格拉姆博士说:“开始向非洲分发R21/Matrix-M疟疾疫苗代表着我们在消除全球健康不平等的使命方面取得了开创性的进展。在印度血清研究所,我们非常自豪能够与尊敬的合作伙伴Novavax和牛津大学以及全球疫苗免疫联盟、联合国儿童基金会和世卫组织合作,使最需要的人能够获得和负担得起这种拯救生命的疫苗。长期以来,疟疾一直是可怕的对手,夺走了无数生命,对非洲最脆弱人口的影响尤其严重。通过将这种疫苗送到前线,我们不仅可以保护个人,还可以增强社区能力,为更光明、无疟疾的未来铺平道路。”

Created by the Jenner Institute of Oxford University and developed by Serum Institute of India, the R21/Matrix-M vaccine contains two key ingredients: the malaria-specific R21 antigen, and Novavax's saponin-based Matrix-M adjuvant to enhance the immune system response, increasing the magnitude and durability of the antibody response. Phase 3 clinical trial results demonstrating safety and efficacy against clinical malaria in children were published in February 2024 in The Lancet.

R21/Matrix-M疫苗由牛津大学詹纳研究所创建,由印度血清研究所开发,含有两种关键成分:疟疾特异性R21抗原和Novavax基于皂素的Matrix-M佐剂,用于增强免疫系统反应,提高抗体反应的强度和耐久性。 3 期临床试验结果 证明对儿童临床疟疾的安全性和有效性已于 2024 年 2 月发表于 《柳叶刀》

Professor Adrian Hill, Director of the Jenner Institute at Oxford University, said, "The start of the distribution at large scale of this high efficacy, very cost-effective vaccine should mark a turning point in the battle against malaria."

牛津大学詹纳研究所所长阿德里安·希尔教授说:“开始大规模分发这种高效、极具成本效益的疫苗应该标志着抗击疟疾的转折点。”

About Novavax

关于 Novavax

Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M adjuvant to enhance the immune response. The Company's portfolio includes its COVID-19 vaccine, and its pipeline includes COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information.

Novavax, Inc.(纳斯达克股票代码:NVAX)通过发现、开发和商业化有助于预防严重传染病的创新疫苗来促进健康改善。总部位于美国马里兰州盖瑟斯堡的跨国公司Novavax提供差异化疫苗平台,该平台结合了重组蛋白方法、创新的纳米颗粒技术和Novavax的专利Matrix-M佐剂,以增强免疫反应。该公司的产品组合包括其 COVID-19 疫苗,其产品线包括COVID-19流感组合和独立流感候选疫苗。此外,Novavax的佐剂被纳入牛津大学和印度血清研究所的R21/Matrix-M疟疾疫苗中。请访问 novavax.com领英 了解更多信息。

Forward-Looking Statements

前瞻性陈述

Statements herein relating to the future of Novavax, its operating plans and prospects, its mission, its partnership with Serum and the impact of the R21/Matrix-M malaria vaccine on the incidence of malaria are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, Novavax's ability to successfully supply Matrix-M to its partner; SII's ability to successfully manufacture, distribute, or market the R21/Matrix-M vaccine, challenges satisfying various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, and constraints on Novavax and its partner's ability to pursue planned regulatory pathways in multiple jurisdictions simultaneously, leading to staggered regulatory filings and potential regulatory actions; challenges or delays in conducting clinical trials; challenges or delays in obtaining regulatory authorization; manufacturing, distribution or export delays or challenges; challenges in obtaining adoption and market acceptance of the R21/Matrix-M vaccine; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). Novavax cautions investors not to place considerable reliance on forward-looking statements contained in this press release. Novavax encourages you to read its filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Novavax's business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

此处有关Novavax的未来、其运营计划和前景、其使命、与Serum的合作以及R21/Matrix-M疟疾疫苗对疟疾发病率的影响的陈述均为前瞻性陈述。Novavax警告说,这些前瞻性陈述存在许多风险和不确定性,可能导致实际结果与此类陈述所表达或暗示的结果存在重大差异。这些风险和不确定性包括但不限于Novavax成功向其合作伙伴供应Matrix-M的能力;SII成功制造、分销或销售R21/Matrix-M疫苗的能力;满足各种安全性、有效性和产品特性要求的挑战,包括与工艺认证、化验验证和稳定性测试相关的要求,这些要求是满足相关监管机构要求所必需的;难以获得稀缺的原材料和供应;资源限制,包括人力资本和制造能力,以及对Novavax及其合作伙伴在多个司法管辖区同时采取计划监管途径的能力的限制,导致监管申报和潜在的监管行动错开进行;开展临床试验的挑战或延迟;获得监管授权的挑战或延迟;制造、分销或出口延迟或挑战;在获得R21/Matrix-M疫苗的采用和市场接受方面面临的挑战;以及 “风险因素” 和 “管理层的” 中确定的其他风险因素Novavax截至2023年12月31日止年度的10-K表年度报告以及随后向美国证券交易委员会(SEC)提交的10-Q表季度报告中的 “财务状况和经营业绩的讨论与分析” 部分。Novavax提醒投资者不要过分依赖本新闻稿中包含的前瞻性陈述。Novavax 鼓励您阅读其向美国证券交易委员会提交的文件,请访问以下网址 www.sec.govwww.novavax.com,用于讨论这些风险和其他风险和不确定性。本新闻稿中的前瞻性陈述仅代表截至本文件发布之日,我们没有义务更新或修改任何陈述。Novavax的业务面临重大风险和不确定性,包括上述风险和不确定性。投资者、潜在投资者和其他人应仔细考虑这些风险和不确定性。

Contacts:

联系人:

Investors
Erika Schultz, Novavax
240-268-2022
ir@novavax.com

投资者
埃里卡·舒尔茨,Novavax
240-268-2022
ir@novavax.com

Media
Giovanna Chandler, Novavax
240-720-7804
media@novavax.com

媒体
乔凡娜·钱德勒,Novavax
240-720-7804
media@novavax.com

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