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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

第一劑R21/Matrix-M瘧疾疫苗運往非洲
諾瓦瓦克斯醫藥 ·  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/矩陣-M 的分佈TM 預計將在未來幾周內開始在整個非洲地區展開

  • 印度血清研究所、Novavax和牛津大學在印度浦那與美國駐印度大使埃裏克·加塞蒂閣下舉行的活動中紀念所取得的成就

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.

馬里蘭州蓋瑟斯堡,2024年5月20日——Novavax, Inc.(納斯達克股票代碼:NVAX)是一家使用其Matrix-M佐劑推進蛋白質疫苗的跨國公司,今天慶祝其合作伙伴印度血清研究所(SII)首批發貨R21/Matrix-M瘧疾疫苗。R21/Matrix-M是第二種獲准用於瘧疾流行地區兒童的瘧疾疫苗,預計將有助於縮小需求與可用劑量之間的差距。預計將在未來幾周內開始向瘧疾發病率高的非洲國家分發。

"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總裁兼首席執行官約翰·雅各布斯表示:“R21/Matrix-M疫苗是一個重要的新工具,可以幫助阻止瘧疾對世界近一半人口的健康和經濟造成毀滅性影響,包括每天有1300名兒童不幸喪生。”“現在,合作比以往任何時候都更加重要,以解決可預防傳染病領域未得到滿足的需求。Novavax爲我們與牛津大學和印度血清研究所的合作以及Matrix-M佐劑在該疫苗中的作用感到自豪,並感謝全球疫苗免疫聯盟和聯合國兒童基金會對該疫苗的推出的支持。”

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.

這批貨物是在印度浦那SII總部舉行的儀式上宣佈的,出席儀式的有美國駐印度大使埃裏克·加塞蒂閣下;SII首席執行官阿達爾·波納瓦拉先生;牛津大學納菲爾德醫學院傳染病臨床講師副研究員梅琳·達圖博士;Novavax執行副總裁、首席企業事務和宣傳官西爾維亞·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."

印度血清研究所研發執行董事烏梅什·沙利格拉姆博士說:“開始向非洲分發R21/Matrix-M瘧疾疫苗代表着我們在消除全球健康不平等的使命方面取得了開創性的進展。在印度血清研究所,我們非常自豪能夠與尊敬的合作伙伴Novavax和牛津大學以及全球疫苗免疫聯盟、聯合國兒童基金會和世衛組織合作,使最需要的人能夠獲得和負擔得起這種拯救生命的疫苗。長期以來,瘧疾一直是可怕的對手,奪走了無數生命,對非洲最脆弱人口的影響尤其嚴重。通過將這種疫苗送到前線,我們不僅可以保護個人,還可以增強社區能力,爲更光明、無瘧疾的未來鋪平道路。”

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疫苗由牛津大學詹納研究所創建,由印度血清研究所開發,含有兩種關鍵成分:瘧疾特異性R21抗原和Novavax基於皁素的Matrix-M佐劑,用於增強免疫系統反應,提高抗體反應的強度和耐久性。 3 期臨床試驗結果 證明對兒童臨床瘧疾的安全性和有效性已於 2024 年 2 月發表於 《柳葉刀》

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."

牛津大學詹納研究所所長阿德里安·希爾教授說:“開始大規模分發這種高效、極具成本效益的疫苗應該標誌着抗擊瘧疾的轉折點。”

About Novavax

關於 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.(納斯達克股票代碼:NVAX)通過發現、開發和商業化有助於預防嚴重傳染病的創新疫苗來促進健康改善。總部位於美國馬里蘭州蓋瑟斯堡的跨國公司Novavax提供差異化疫苗平台,該平台結合了重組蛋白方法、創新的納米顆粒技術和Novavax的專利Matrix-M佐劑,以增強免疫反應。該公司的產品組合包括其 COVID-19 疫苗,其產品線包括COVID-19流感組合和獨立流感候選疫苗。此外,Novavax的佐劑被納入牛津大學和印度血清研究所的R21/Matrix-M瘧疾疫苗中。請訪問 novavax.com領英 了解更多信息。

Forward-Looking Statements

前瞻性陳述

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.

此處有關Novavax的未來、其運營計劃和前景、其使命、與Serum的合作以及R21/Matrix-M瘧疾疫苗對瘧疾發病率的影響的陳述均爲前瞻性陳述。Novavax警告說,這些前瞻性陳述存在許多風險和不確定性,可能導致實際結果與此類陳述所表達或暗示的結果存在重大差異。這些風險和不確定性包括但不限於Novavax成功向其合作伙伴供應Matrix-M的能力;SII成功製造、分銷或銷售R21/Matrix-M疫苗的能力;滿足各種安全性、有效性和產品特性要求的挑戰,包括與工藝認證、化驗驗證和穩定性測試相關的要求,這些要求是滿足相關監管機構要求所必需的;難以獲得稀缺的原材料和供應;資源限制,包括人力資本和製造能力,以及對Novavax及其合作伙伴在多個司法管轄區同時採取計劃監管途徑的能力的限制,導致監管申報和潛在的監管行動錯開進行;開展臨床試驗的挑戰或延遲;獲得監管授權的挑戰或延遲;製造、分銷或出口延遲或挑戰;在獲得R21/Matrix-M疫苗的採用和市場接受方面面臨的挑戰;以及 “風險因素” 和 “管理層的” 中確定的其他風險因素Novavax截至2023年12月31日止年度的10-K表年度報告以及隨後向美國證券交易委員會(SEC)提交的10-Q表季度報告中的 “財務狀況和經營業績的討論與分析” 部分。Novavax提醒投資者不要過分依賴本新聞稿中包含的前瞻性陳述。Novavax 鼓勵您閱讀其向美國證券交易委員會提交的文件,請訪問以下網址 www.sec.govwww.novavax.com,用於討論這些風險和其他風險和不確定性。本新聞稿中的前瞻性陳述僅代表截至本文件發佈之日,我們沒有義務更新或修改任何陳述。Novavax的業務面臨重大風險和不確定性,包括上述風險和不確定性。投資者、潛在投資者和其他人應仔細考慮這些風險和不確定性。

Contacts:

聯繫人:

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

投資者
埃裏卡·舒爾茨,Novavax
240-268-2022
ir@novavax.com

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

媒體
喬凡娜·錢德勒,Novavax
240-720-7804
media@novavax.com

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