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Novavax to Supply Updated COVID-19 Vaccine to Private Healthcare Providers in the United Kingdom

Novavax to Supply Updated COVID-19 Vaccine to Private Healthcare Providers in the United Kingdom

Novavax 將向英國的私人醫療保健提供者提供更新的 COVID-19 疫苗
諾瓦瓦克斯醫藥 ·  04/18 12:00

For Global Investor Audience Only

僅限全球投資者受衆

Novavax's Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) is now available to pharmacies across the United Kingdom (U.K.) for private healthcare providers to offer an updated protein-based non-mRNA option as part of the 2024 vaccination season.

Novavax的注射用Nuvaxovid XBB.1.5分散體,COVID-19 疫苗(重組,佐劑)(nvx-CoV2601)現已向英國(英國)各地的藥房上市,供私人醫療保健提供者在2024年疫苗接種季節提供更新的基於蛋白質的非mRNA選項。

Today is an important milestone for our organization. It demonstrates our commitment to deliver an updated protein-based COVID-19 vaccine as we evolve into an endemic market. It also underscores our place as a long-term partner to public health. We believe a diverse vaccine portfolio and broader access can play vital roles in protecting communities in the U.K. and elsewhere.

今天是我們組織的重要里程碑。它表明,隨着我們向流行市場的發展,我們致力於提供更新的基於蛋白質的 COVID-19 疫苗。它還凸顯了我們作爲公共衛生長期合作伙伴的地位。我們認爲,多樣化的疫苗組合和更廣泛的可及性可以在保護英國和其他地方的社區方面發揮至關重要的作用。

Our participation in the U.K. private market follows receipt of a Wholesale Dealers License from the U.K. Medicines and Healthcare products Regulatory Agency as well as the U.K. Health Security Agency's latest Green Book update in February 2024 to include our updated COVID-19 vaccine for active immunization to prevent COVID-19 in individuals aged 12 and older.

我們參與英國私人市場之前,我們獲得了英國藥品和保健產品監管局的批發經銷商許可證,以及英國健康安全局於 2024 年 2 月發佈的最新綠皮書,其中包括我們更新的 COVID-19 主動免疫疫苗,以預防 12 歲及以上人群的 COVID-19。

A key component of Novavax's COVID-19 vaccine is our Matrix-M adjuvant which enhances the antigen-specific immune system response, making it broader and more durable. The adjuvant is also used in the R21/Matrix-M malaria vaccine, developed by University of Oxford and the Serum Institute of India, as well as development-stage vaccines, including our COVID-19-Influenza Combination vaccine candidate and influenza vaccine candidate.

Novavax COVID-19 疫苗的關鍵組成部分是我們的 Matrix-M 輔助劑 它增強了抗原特異性免疫系統的反應,使其更廣泛、更耐用。該輔助劑還用於 R21/Matrix-M 瘧疾疫苗,由牛津大學和印度血清研究所開發,以及處於開發階段的疫苗,包括我們的COVID-19流感聯合疫苗候選疫苗和流感候選疫苗。

In 2023, Novavax signed a three-year agreement with the Bill & Melinda Gates Medical Research Institute to provide Matrix-M for use in preclinical vaccine research, helping to develop biomedical interventions that address global health concerns for those in the greatest need.

2023 年,Novavax 簽署了爲期三年的協議 與比爾和梅琳達·蓋茨醫學研究所的協議 提供用於臨床前疫苗研究的Matrix-M,幫助開發生物醫學干預措施,爲最需要的人解決全球健康問題。

Forward-Looking Statements

前瞻性陳述

Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 (recombinant, adjuvanted) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine in the United Kingdom 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, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the 2024-2025vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; 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). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our 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. Our 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、其運營計劃和前景的陳述,包括其更新後的Novavax COVID-19(重組、佐劑)(NVX-CoV2601)XBB版本的上市情況以及其疫苗在英國的交付和分發時間均爲前瞻性陳述。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單獨或與合作伙伴共同滿足各種安全性、有效性和產品特性要求的挑戰,包括滿足相關監管機構要求所必需的與工藝認證和化驗驗證相關的挑戰;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,影響Novavax採取計劃監管途徑的能力;在獲得監管授權方面的挑戰或延遲其候選產品,包括在 2024-2025 年疫苗接種季節或未來 COVID-19 變種菌株變化之前及時更新的 COVID-19 疫苗 XBB 版本;臨床試驗的挑戰或延遲;製造、分銷或出口延遲或挑戰;Novavax 完全依賴印度血清研究所私人有限公司進行共同配方和灌裝,以及其運營延遲或中斷對客戶訂單交付的影響;滿足與多個商業協議下的合同要求的挑戰,政府和其他實體;以及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 “風險因素” 和 “管理層對財務狀況和經營業績的討論和分析” 部分中確定的其他風險因素。我們提醒投資者不要過分依賴本新聞稿中包含的前瞻性陳述。我們鼓勵您閱讀我們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聲明。我們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。

譯文內容由第三人軟體翻譯。


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