<p><em><strong>mNEXSPIKE 成為 Moderna 第三款獲得 FDA 批准的產品</strong></em></p>
<p>Moderna, Inc.（納斯達克代碼：MRNA）今天宣佈，美國食品藥品監督管理局（FDA）已批准 mNEXSPIKE <strong>®</strong>（mRNA-1283），這是一種針對 COVID-19 的新疫苗，適用於所有 65 歲及以上的成年人，以及 12 至 64 歲之間具有至少一個或多個基礎風險因素的個體，具體定義由疾病控制與預防中心（CDC）提供。[1]</p>
<p>&#34;FDA 批准我們的第三款產品 mNEXSPIKE，為保護高風險嚴重疾病的 COVID-19 患者提供了一個重要的新工具，&#34;Moderna 首席執行官 Stéphane Bancel 表示。&#34;COVID-19 仍然是一個嚴重的公共衞生威脅，僅去年就有超過 47,000 名美國人死於該病毒。我們感謝 FDA 的及時審查，並感謝整個 Moderna 團隊的辛勤工作和對公共衞生的持續承諾。&#34;</p>
<p>FDA 對 mNEXSPIKE 的批准基於一項隨機、觀察者盲法、主動對照的三期臨牀試驗結果（ClinicalTrials.gov 標識符：NCT05815498），該試驗招募了約 11,400 名年齡在 12 歲及以上的參與者。本研究的主要有效性目標是證明 mNEXSPIKE 在接種後 14 天開始對 COVID-19 的疫苗有效性不劣於對照疫苗 mRNA-1273（Spikevax®），即 Moderna 的原始 COVID-19 疫苗。參與者接受了 10 微克的 mRNA-1283 或 50 微克的 mRNA-1273。mRNA-1283 在 12 歲及以上個體中顯示出相對於 mRNA-1273 高出 9.3% 的相對疫苗有效性（rVE），在描述性亞組分析中，65 歲及以上成年人中 rVE 高出 13.5%。</p>
<p>在三期試驗中，mRNA-1283 的安全性與 mRNA-1273 相似，局部反應較少，系統反應相當。最常見的副作用包括注射部位疼痛、疲勞、頭痛和肌肉疼痛。</p>
<p>Moderna 預計將在 2025-2026 呼吸病毒季節為符合條件的人羣提供 mNEXSPIKE，與 Spikevax 和公司批准的呼吸道合胞病毒（RSV）疫苗 mRESVIA <strong>®</strong> 一同推出。</p>
<p>mRNA-1283 正在全球多個市場接受監管審查。</p>
<p><strong>關於 Moderna</strong></p>
<p>Moderna 是 mRNA 醫學領域的領導者。通過推進 mRNA 技術，Moderna 正在重新構想藥物的製造方式，並改變我們治療和預防疾病的方式。公司在科學、技術和健康的交匯點上工作超過十年，開發出前所未有的速度和效率的藥物，包括最早和最有效的 COVID-19 疫苗之一。</p>
<p>Moderna 的 mRNA 平台使得針對傳染病、免疫腫瘤學、罕見疾病和自身免疫疾病的治療和疫苗的開發成為可能。憑藉獨特的文化和全球團隊，Moderna 致力於通過 mRNA 藥物為人類健康的未來負責任地帶來最大的影響。有關 Moderna 的更多信息，請訪問 modernatx.com，並在 X（前身為 Twitter）、Facebook、Instagram、YouTube 和 LinkedIn 上與我們聯繫。</p>
<p>mNEXSPIKE®、mRESVIA <strong>®</strong> 和 Spikevax®是 Moderna 的註冊商標。</p>
<p><strong>適應症</strong></p>
<p>mNEXSPIKE 是一種保護人們免受 COVID-19 的疫苗。mNEXSPIKE 適用於之前接種過 COVID-19 疫苗的人羣，且符合以下條件：</p>
<p>• 65 歲及以上，或</p>
<p>• 12 歲至 64 歲之間，且面臨嚴重 COVID-19 的高風險。</p>
<p>接種 mNEXSPIKE 可能無法保護所有接種疫苗的人。</p>
<p><strong>重要安全信息</strong></p>
<p><strong>如果您曾在接種過 mNEXSPIKE、SPIKEVAX（COVID-19 疫苗，mRNA）或任何 Moderna COVID-19 疫苗後出現嚴重過敏反應，則不應接種 mNEXSPIKE。</strong></p>
<p><strong>mNEXSPIKE 的風險是什麼？</strong></p>
<p>mNEXSPIKE 可能導致嚴重過敏反應的幾率非常小。嚴重過敏反應通常會在接種 mNEXSPIKE 後幾分鐘到 1 小時內發生。因此，您的醫療提供者可能會要求您在接種疫苗的地方稍作停留。嚴重過敏反應的跡象包括：</p>
<ul>
<li>呼吸困難</li>
</ul>
<ul>
<li>面部和喉嚨腫脹</li>
</ul>
<ul>
<li>心跳加速</li>
</ul>
<ul>
<li>全身皮疹</li>
</ul>
<ul>
<li>頭暈和虛弱</li>
</ul>
<p>在接種 mRNA COVID-19 疫苗的某些人中，已發生心肌炎（心肌炎症）和心包炎（心臟外膜炎症）。接種 mRNA COVID-19 疫苗後，心肌炎和心包炎在 12 歲至 24 歲男性中最為常見。如果您或您的孩子在接種疫苗後，特別是在接種疫苗後的兩週內出現以下任何症狀，請立即尋求醫療幫助：</p>
<ul>
<li>胸痛</li>
</ul>
<ul>
<li>呼吸急促</li>
</ul>
<ul>
<li>感覺心跳加速、心悸或心臟劇烈跳動</li>
</ul>
<p>在 mNEXSPIKE 的臨牀試驗中報告的副作用包括：</p>
<ul>
<li>注射部位反應：疼痛、壓痛和同側淋巴結腫大、腫脹（硬度）和紅腫。</li>
</ul>
<ul>
<li>一般副作用：疲勞、頭痛、肌肉疼痛、關節疼痛、寒戰、噁心、嘔吐和發熱。</li>
</ul>
<p><strong>告知您的接種提供者您所有的醫療狀況，包括如果您：</strong></p>
<ul>
<li>有任何過敏史</li>
</ul>
<ul>
<li>在接種過任何 COVID-19 疫苗後出現過嚴重過敏反應</li>
</ul>
<ul>
<li>曾患有心肌炎（心肌炎症）或心包炎（心臟外膜炎症）</li>
</ul>
<ul>
<li>有發熱</li>
</ul>
<ul>
<li>有出血性疾病或正在服用抗凝藥物</li>
</ul>
<ul>
<li>免疫系統受損或正在服用影響免疫系統的藥物</li>
</ul>
<ul>
<li>懷孕或計劃懷孕</li>
</ul>
<ul>
<li>正在哺乳</li>
</ul>
<ul>
<li>接種過任何其他 COVID-19 疫苗</li>
</ul>
<ul>
<li>曾在注射時暈厥過</li>
</ul>
<p>這些可能不是 mNEXSPIKE 的所有可能副作用。請向您的醫療保健提供者詢問任何讓您擔憂的副作用。您可以通過 <strong>疫苗不良事件報告系統 (VAERS)</strong> 報告副作用，電話是 1-800-822-7967 或訪問 http://vaers.hhs.gov。</p>
<p>請點擊查看 mNEXSPIKE 完整處方信息。</p>
<p><strong>前瞻性聲明</strong></p>
<p>本新聞稿包含根據 1995 年《私人證券訴訟改革法》及其修正案的定義的前瞻性聲明，包括關於：mNEXSPIKE 的有效性、安全性和耐受性；以及 Moderna 在 2025-2026 賽季的呼吸道疫苗的可用性。本新聞稿中的前瞻性聲明既不是承諾也不是保證，您不應對這些前瞻性聲明過度依賴，因為它們涉及已知和未知的風險、不確定性以及其他因素，其中許多超出了 Moderna 的控制範圍，並可能導致實際結果與這些前瞻性聲明所表達或暗示的結果有實質性差異。這些風險、不確定性和其他因素包括但不限於在 Moderna 2024 財年截至 12 月 31 日的 10-K 表格年報中以及 Moderna 隨後向美國證券交易委員會提交的文件中描述的 “風險因素” 部分，這些文件可在 SEC 的網站 www.sec.gov 上獲取。除法律要求外，Moderna 不承擔更新或修訂本新聞稿中包含的任何前瞻性聲明的意圖或責任，尤其是在出現新信息、未來發展或其他情況下。這些前瞻性聲明基於 Moderna 當前的預期，僅在本新聞稿日期時有效。</p>
<p><strong>Moderna 聯繫人</strong></p>
<p>媒體：</p>
<p>Chris Ridley</p>
<p>全球媒體關係負責人</p>
<p>+1 617-800-3651</p>
<p>Chris.Ridley@modernatx.com</p>
<p>投資者：</p>
<p>Lavina Talukdar</p>
<p>高級副總裁兼投資者關係負責人</p>
<p>+1 617-209-5834</p>
<p>Lavina.Talukdar@modernatx.com</p>
<p>[1] https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html</p>
<p><strong>來源：</strong> Moderna, Inc.</p>
<p>查看原始新聞稿請訪問 ACCESS Newswire</p>
<p><img src="https://imageproxy.pbkrs.com/https://app.accessnewswire.com/img.ashx/query-aWQ9MTAzNDEzMQ?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://app.accessnewswire.com/img.ashx/query-aWQ9MTAzNDEzMQ"/></p>

MRNA

<p>Moderna, Inc. 已獲得 FDA 對其 COVID-19 疫苗 mNEXSPIKE 的批准，針對 65 歲及以上的成年人以及 12 至 64 歲有基礎健康風險的個體。這標誌着 Moderna 的第三款 FDA 批准產品。該批准基於一項 III 期試驗，顯示 mNEXSPIKE 的有效性比其前身 mRNA-1273 高出 9.3%，且安全性相似。mNEXSPIKE 預計將在 2025-2026 年呼吸道病毒季節上市。Moderna 繼續在 mRNA 醫藥開發領域處於領先地位，專注於各種疾病的創新治療</p>

<p><em><strong>mNEXSPIKE becomes Moderna's third FDA-approved product</strong></em></p>
<div class="lb-trans"><p><em><strong>mNEXSPIKE 成為 Moderna 第三款獲得 FDA 批准的產品</strong></em></p>
</div><p>Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE <strong>®</strong> (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).[1]</p>
<div class="lb-trans"><p>Moderna, Inc.（納斯達克代碼：MRNA）今天宣佈，美國食品藥品監督管理局（FDA）已批准 mNEXSPIKE <strong>®</strong>（mRNA-1283），這是一種針對 COVID-19 的新疫苗，適用於所有 65 歲及以上的成年人，以及 12 至 64 歲之間具有至少一個或多個基礎風險因素的個體，具體定義由疾病控制與預防中心（CDC）提供。[1]</p>
</div><p>&#34;The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19,&#34; said Stéphane Bancel, Chief Executive Officer of Moderna. &#34;COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health.&#34;</p>
<div class="lb-trans"><p>&#34;FDA 批准我們的第三款產品 mNEXSPIKE，為保護高風險嚴重疾病的 COVID-19 患者提供了一個重要的新工具，&#34;Moderna 首席執行官 Stéphane Bancel 表示。&#34;COVID-19 仍然是一個嚴重的公共衞生威脅，僅去年就有超過 47,000 名美國人死於該病毒。我們感謝 FDA 的及時審查，並感謝整個 Moderna 團隊的辛勤工作和對公共衞生的持續承諾。&#34;</p>
</div><p>The FDA's approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax®), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.</p>
<div class="lb-trans"><p>FDA 對 mNEXSPIKE 的批准基於一項隨機、觀察者盲法、主動對照的三期臨牀試驗結果（ClinicalTrials.gov 標識符：NCT05815498），該試驗招募了約 11,400 名年齡在 12 歲及以上的參與者。本研究的主要有效性目標是證明 mNEXSPIKE 在接種後 14 天開始對 COVID-19 的疫苗有效性不劣於對照疫苗 mRNA-1273（Spikevax®），即 Moderna 的原始 COVID-19 疫苗。參與者接受了 10 微克的 mRNA-1283 或 50 微克的 mRNA-1273。mRNA-1283 在 12 歲及以上個體中顯示出相對於 mRNA-1273 高出 9.3% 的相對疫苗有效性（rVE），在描述性亞組分析中，65 歲及以上成年人中 rVE 高出 13.5%。</p>
</div><p>In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.</p>
<div class="lb-trans"><p>在三期試驗中，mRNA-1283 的安全性與 mRNA-1273 相似，局部反應較少，系統反應相當。最常見的副作用包括注射部位疼痛、疲勞、頭痛和肌肉疼痛。</p>
</div><p>Moderna expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA <strong>®</strong>, the Company's approved respiratory syncytial virus (RSV) vaccine.</p>
<div class="lb-trans"><p>Moderna 預計將在 2025-2026 呼吸病毒季節為符合條件的人羣提供 mNEXSPIKE，與 Spikevax 和公司批准的呼吸道合胞病毒（RSV）疫苗 mRESVIA <strong>®</strong> 一同推出。</p>
</div><p>mRNA-1283 is under review with regulators in multiple markets around the world.</p>
<div class="lb-trans"><p>mRNA-1283 正在全球多個市場接受監管審查。</p>
</div><p><strong>About Moderna</strong></p>
<div class="lb-trans"><p><strong>關於 Moderna</strong></p>
</div><p>Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.</p>
<div class="lb-trans"><p>Moderna 是 mRNA 醫學領域的領導者。通過推進 mRNA 技術，Moderna 正在重新構想藥物的製造方式，並改變我們治療和預防疾病的方式。公司在科學、技術和健康的交匯點上工作超過十年，開發出前所未有的速度和效率的藥物，包括最早和最有效的 COVID-19 疫苗之一。</p>
</div><p>Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.</p>
<div class="lb-trans"><p>Moderna 的 mRNA 平台使得針對傳染病、免疫腫瘤學、罕見疾病和自身免疫疾病的治療和疫苗的開發成為可能。憑藉獨特的文化和全球團隊，Moderna 致力於通過 mRNA 藥物為人類健康的未來負責任地帶來最大的影響。有關 Moderna 的更多信息，請訪問 modernatx.com，並在 X（前身為 Twitter）、Facebook、Instagram、YouTube 和 LinkedIn 上與我們聯繫。</p>
</div><p>mNEXSPIKE®, mRESVIA <strong>®</strong> and Spikevax®are registered trademarks of Moderna.</p>
<div class="lb-trans"><p>mNEXSPIKE®、mRESVIA <strong>®</strong> 和 Spikevax®是 Moderna 的註冊商標。</p>
</div><p><strong>INDICATION</strong></p>
<div class="lb-trans"><p><strong>適應症</strong></p>
</div><p>mNEXSPIKE is a vaccine to protect against COVID-19. mNEXSPIKE is for people who have received a COVID-19 vaccine before and are:</p>
<div class="lb-trans"><p>mNEXSPIKE 是一種保護人們免受 COVID-19 的疫苗。mNEXSPIKE 適用於之前接種過 COVID-19 疫苗的人羣，且符合以下條件：</p>
</div><p>• 65 years of age and older, or</p>
<div class="lb-trans"><p>• 65 歲及以上，或</p>
</div><p>• 12 years through 64 years of age at high risk for severe COVID-19.</p>
<div class="lb-trans"><p>• 12 歲至 64 歲之間，且面臨嚴重 COVID-19 的高風險。</p>
</div><p>Vaccination with mNEXSPIKE may not protect all people who receive the vaccine.</p>
<div class="lb-trans"><p>接種 mNEXSPIKE 可能無法保護所有接種疫苗的人。</p>
</div><p><strong>IMPORTANT SAFETY INFORMATION</strong></p>
<div class="lb-trans"><p><strong>重要安全信息</strong></p>
</div><p><strong>You should not get mNEXSPIKE if</strong> you hada severe allergic reaction after a previous dose of either mNEXSPIKE, SPIKEVAX (COVID-19 Vaccine, mRNA), or any Moderna COVID-19 vaccine or to any ingredient in these vaccines.</p>
<div class="lb-trans"><p><strong>如果您曾在接種過 mNEXSPIKE、SPIKEVAX（COVID-19 疫苗，mRNA）或任何 Moderna COVID-19 疫苗後出現嚴重過敏反應，則不應接種 mNEXSPIKE。</strong></p>
</div><p><strong>What are the risks of mNEXSPIKE?</strong></p>
<div class="lb-trans"><p><strong>mNEXSPIKE 的風險是什麼？</strong></p>
</div><p>There is a very small chance that mNEXSPIKE could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of mNEXSPIKE. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction can include:</p>
<div class="lb-trans"><p>mNEXSPIKE 可能導致嚴重過敏反應的幾率非常小。嚴重過敏反應通常會在接種 mNEXSPIKE 後幾分鐘到 1 小時內發生。因此，您的醫療提供者可能會要求您在接種疫苗的地方稍作停留。嚴重過敏反應的跡象包括：</p>
</div><ul>
<li>Trouble breathing</li>
</ul>
<div class="lb-trans"><ul>
<li>呼吸困難</li>
</ul>
</div><ul>
<li>Swelling of your face and throat</li>
</ul>
<div class="lb-trans"><ul>
<li>面部和喉嚨腫脹</li>
</ul>
</div><ul>
<li>A fast heartbeat</li>
</ul>
<div class="lb-trans"><ul>
<li>心跳加速</li>
</ul>
</div><ul>
<li>A rash all over your body</li>
</ul>
<div class="lb-trans"><ul>
<li>全身皮疹</li>
</ul>
</div><ul>
<li>Dizziness and weakness</li>
</ul>
<div class="lb-trans"><ul>
<li>頭暈和虛弱</li>
</ul>
</div><p>Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received mRNA COVID-19 vaccines. Myocarditis and pericarditis following mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. You should seek medical attention right away if you or your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:</p>
<div class="lb-trans"><p>在接種 mRNA COVID-19 疫苗的某些人中，已發生心肌炎（心肌炎症）和心包炎（心臟外膜炎症）。接種 mRNA COVID-19 疫苗後，心肌炎和心包炎在 12 歲至 24 歲男性中最為常見。如果您或您的孩子在接種疫苗後，特別是在接種疫苗後的兩週內出現以下任何症狀，請立即尋求醫療幫助：</p>
</div><ul>
<li>Chest pain</li>
</ul>
<div class="lb-trans"><ul>
<li>胸痛</li>
</ul>
</div><ul>
<li>Shortness of breath</li>
</ul>
<div class="lb-trans"><ul>
<li>呼吸急促</li>
</ul>
</div><ul>
<li>Feelings of having a fast-beating, fluttering, or pounding heart</li>
</ul>
<div class="lb-trans"><ul>
<li>感覺心跳加速、心悸或心臟劇烈跳動</li>
</ul>
</div><p>Side effects that have been reported in clinical trials with mNEXSPIKE include:</p>
<div class="lb-trans"><p>在 mNEXSPIKE 的臨牀試驗中報告的副作用包括：</p>
</div><ul>
<li>Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling (hardness), and redness.</li>
</ul>
<div class="lb-trans"><ul>
<li>注射部位反應：疼痛、壓痛和同側淋巴結腫大、腫脹（硬度）和紅腫。</li>
</ul>
</div><ul>
<li>General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea, vomiting, and fever</li>
</ul>
<div class="lb-trans"><ul>
<li>一般副作用：疲勞、頭痛、肌肉疼痛、關節疼痛、寒戰、噁心、嘔吐和發熱。</li>
</ul>
</div><p><strong>Tell your vaccination provider about all of your medical conditions, including if you:</strong></p>
<div class="lb-trans"><p><strong>告知您的接種提供者您所有的醫療狀況，包括如果您：</strong></p>
</div><ul>
<li>have any allergies</li>
</ul>
<div class="lb-trans"><ul>
<li>有任何過敏史</li>
</ul>
</div><ul>
<li>had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine</li>
</ul>
<div class="lb-trans"><ul>
<li>在接種過任何 COVID-19 疫苗後出現過嚴重過敏反應</li>
</ul>
</div><ul>
<li>have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)</li>
</ul>
<div class="lb-trans"><ul>
<li>曾患有心肌炎（心肌炎症）或心包炎（心臟外膜炎症）</li>
</ul>
</div><ul>
<li>have a fever</li>
</ul>
<div class="lb-trans"><ul>
<li>有發熱</li>
</ul>
</div><ul>
<li>have a bleeding disorder or are on a blood thinner</li>
</ul>
<div class="lb-trans"><ul>
<li>有出血性疾病或正在服用抗凝藥物</li>
</ul>
</div><ul>
<li>are immunocompromised or are on a medicine that affects your immune system</li>
</ul>
<div class="lb-trans"><ul>
<li>免疫系統受損或正在服用影響免疫系統的藥物</li>
</ul>
</div><ul>
<li>are pregnant or plan to become pregnant</li>
</ul>
<div class="lb-trans"><ul>
<li>懷孕或計劃懷孕</li>
</ul>
</div><ul>
<li>are breastfeeding</li>
</ul>
<div class="lb-trans"><ul>
<li>正在哺乳</li>
</ul>
</div><ul>
<li>have received any other COVID-19 vaccine</li>
</ul>
<div class="lb-trans"><ul>
<li>接種過任何其他 COVID-19 疫苗</li>
</ul>
</div><ul>
<li>have ever fainted in association with an injection</li>
</ul>
<div class="lb-trans"><ul>
<li>曾在注射時暈厥過</li>
</ul>
</div><p>These may not be all the possible side effects of mNEXSPIKE. Ask your healthcare provider about any side effects that concern you. You may report side effects to <strong>Vaccine Adverse Event Reporting System (VAERS)</strong> at 1-800-822-7967 or http://vaers.hhs.gov.</p>
<div class="lb-trans"><p>這些可能不是 mNEXSPIKE 的所有可能副作用。請向您的醫療保健提供者詢問任何讓您擔憂的副作用。您可以通過 <strong>疫苗不良事件報告系統 (VAERS)</strong> 報告副作用，電話是 1-800-822-7967 或訪問 http://vaers.hhs.gov。</p>
</div><p>Please click for mNEXSPIKE Full Prescribing Information.</p>
<div class="lb-trans"><p>請點擊查看 mNEXSPIKE 完整處方信息。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性聲明</strong></p>
</div><p>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the efficacy, safety and tolerability of mNEXSPIKE; and the availability of Moderna's respiratory vaccines for the 2025-2026 season. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading &#34;Risk Factors&#34; in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.</p>
<div class="lb-trans"><p>本新聞稿包含根據 1995 年《私人證券訴訟改革法》及其修正案的定義的前瞻性聲明，包括關於：mNEXSPIKE 的有效性、安全性和耐受性；以及 Moderna 在 2025-2026 賽季的呼吸道疫苗的可用性。本新聞稿中的前瞻性聲明既不是承諾也不是保證，您不應對這些前瞻性聲明過度依賴，因為它們涉及已知和未知的風險、不確定性以及其他因素，其中許多超出了 Moderna 的控制範圍，並可能導致實際結果與這些前瞻性聲明所表達或暗示的結果有實質性差異。這些風險、不確定性和其他因素包括但不限於在 Moderna 2024 財年截至 12 月 31 日的 10-K 表格年報中以及 Moderna 隨後向美國證券交易委員會提交的文件中描述的 “風險因素” 部分，這些文件可在 SEC 的網站 www.sec.gov 上獲取。除法律要求外，Moderna 不承擔更新或修訂本新聞稿中包含的任何前瞻性聲明的意圖或責任，尤其是在出現新信息、未來發展或其他情況下。這些前瞻性聲明基於 Moderna 當前的預期，僅在本新聞稿日期時有效。</p>
</div><p><strong>Moderna Contacts</strong></p>
<div class="lb-trans"><p><strong>Moderna 聯繫人</strong></p>
</div><p>Media:</p>
<div class="lb-trans"><p>媒體：</p>
</div><p>Chris Ridley</p>
<div class="lb-trans"><p>Chris Ridley</p>
</div><p>Head of Global Media Relations</p>
<div class="lb-trans"><p>全球媒體關係負責人</p>
</div><p>+1 617-800-3651</p>
<div class="lb-trans"><p>+1 617-800-3651</p>
</div><p>Chris.Ridley@modernatx.com</p>
<div class="lb-trans"><p>Chris.Ridley@modernatx.com</p>
</div><p>Investors:</p>
<div class="lb-trans"><p>投資者：</p>
</div><p>Lavina Talukdar</p>
<div class="lb-trans"><p>Lavina Talukdar</p>
</div><p>Senior Vice President &amp; Head of Investor Relations</p>
<div class="lb-trans"><p>高級副總裁兼投資者關係負責人</p>
</div><p>+1 617-209-5834</p>
<div class="lb-trans"><p>+1 617-209-5834</p>
</div><p>Lavina.Talukdar@modernatx.com</p>
<div class="lb-trans"><p>Lavina.Talukdar@modernatx.com</p>
</div><p>[1] https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html</p>
<div class="lb-trans"><p>[1] https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html</p>
</div><p><strong>SOURCE:</strong> Moderna, Inc.</p>
<div class="lb-trans"><p><strong>來源：</strong> Moderna, Inc.</p>
</div><p>View the original press release on ACCESS Newswire</p>
<div class="lb-trans"><p>查看原始新聞稿請訪問 ACCESS Newswire</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://app.accessnewswire.com/img.ashx/query-aWQ9MTAzNDEzMQ" alt="" original-src="https://app.accessnewswire.com/img.ashx?id=1034131"/></p>

Moderna 獲得美國 FDA 批准其 COVID-19 疫苗 mNEXSPIKE | MRNA 股票新聞