<p><em><strong>mNEXSPIKE 成为 Moderna 第三款获得 FDA 批准的产品</strong></em></p>
<p>Moderna, Inc.（纳斯达克代码：MRNA）今天宣布，美国食品药品监督管理局（FDA）已批准 mNEXSPIKE <strong>®</strong>（mRNA-1283），这是一种针对 COVID-19 的新疫苗，适用于所有 65 岁及以上的成年人，以及 12 至 64 岁之间具有至少一个或多个基础风险因素的个体，具体定义由疾病控制与预防中心（CDC）提供。[1]</p>
<p>&#34;FDA 批准我们的第三款产品 mNEXSPIKE，为保护高风险严重疾病的 COVID-19 患者提供了一个重要的新工具，&#34;Moderna 首席执行官 Stéphane Bancel 表示。&#34;COVID-19 仍然是一个严重的公共卫生威胁，仅去年就有超过 47,000 名美国人死于该病毒。我们感谢 FDA 的及时审查，并感谢整个 Moderna 团队的辛勤工作和对公共卫生的持续承诺。&#34;</p>
<p>FDA 对 mNEXSPIKE 的批准基于一项随机、观察者盲法、主动对照的三期临床试验结果（ClinicalTrials.gov 标识符：NCT05815498），该试验招募了约 11,400 名年龄在 12 岁及以上的参与者。本研究的主要有效性目标是证明 mNEXSPIKE 在接种后 14 天开始对 COVID-19 的疫苗有效性不劣于对照疫苗 mRNA-1273（Spikevax®），即 Moderna 的原始 COVID-19 疫苗。参与者接受了 10 微克的 mRNA-1283 或 50 微克的 mRNA-1273。mRNA-1283 在 12 岁及以上个体中显示出相对于 mRNA-1273 高出 9.3% 的相对疫苗有效性（rVE），在描述性亚组分析中，65 岁及以上成年人中 rVE 高出 13.5%。</p>
<p>在三期试验中，mRNA-1283 的安全性与 mRNA-1273 相似，局部反应较少，系统反应相当。最常见的副作用包括注射部位疼痛、疲劳、头痛和肌肉疼痛。</p>
<p>Moderna 预计将在 2025-2026 呼吸病毒季节为符合条件的人群提供 mNEXSPIKE，与 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 正在全球多个市场接受监管审查。</p>
<p><strong>关于 Moderna</strong></p>
<p>Moderna 是 mRNA 医学领域的领导者。通过推进 mRNA 技术，Moderna 正在重新构想药物的制造方式，并改变我们治疗和预防疾病的方式。公司在科学、技术和健康的交汇点上工作超过十年，开发出前所未有的速度和效率的药物，包括最早和最有效的 COVID-19 疫苗之一。</p>
<p>Moderna 的 mRNA 平台使得针对传染病、免疫肿瘤学、罕见疾病和自身免疫疾病的治疗和疫苗的开发成为可能。凭借独特的文化和全球团队，Moderna 致力于通过 mRNA 药物为人类健康的未来负责任地带来最大的影响。有关 Moderna 的更多信息，请访问 modernatx.com，并在 X（前身为 Twitter）、Facebook、Instagram、YouTube 和 LinkedIn 上与我们联系。</p>
<p>mNEXSPIKE®、mRESVIA <strong>®</strong> 和 Spikevax®是 Moderna 的注册商标。</p>
<p><strong>适应症</strong></p>
<p>mNEXSPIKE 是一种保护人们免受 COVID-19 的疫苗。mNEXSPIKE 适用于之前接种过 COVID-19 疫苗的人群，且符合以下条件：</p>
<p>• 65 岁及以上，或</p>
<p>• 12 岁至 64 岁之间，且面临严重 COVID-19 的高风险。</p>
<p>接种 mNEXSPIKE 可能无法保护所有接种疫苗的人。</p>
<p><strong>重要安全信息</strong></p>
<p><strong>如果您曾在接种过 mNEXSPIKE、SPIKEVAX（COVID-19 疫苗，mRNA）或任何 Moderna COVID-19 疫苗后出现严重过敏反应，则不应接种 mNEXSPIKE。</strong></p>
<p><strong>mNEXSPIKE 的风险是什么？</strong></p>
<p>mNEXSPIKE 可能导致严重过敏反应的几率非常小。严重过敏反应通常会在接种 mNEXSPIKE 后几分钟到 1 小时内发生。因此，您的医疗提供者可能会要求您在接种疫苗的地方稍作停留。严重过敏反应的迹象包括：</p>
<ul>
<li>呼吸困难</li>
</ul>
<ul>
<li>面部和喉咙肿胀</li>
</ul>
<ul>
<li>心跳加速</li>
</ul>
<ul>
<li>全身皮疹</li>
</ul>
<ul>
<li>头晕和虚弱</li>
</ul>
<p>在接种 mRNA COVID-19 疫苗的某些人中，已发生心肌炎（心肌炎症）和心包炎（心脏外膜炎症）。接种 mRNA COVID-19 疫苗后，心肌炎和心包炎在 12 岁至 24 岁男性中最为常见。如果您或您的孩子在接种疫苗后，特别是在接种疫苗后的两周内出现以下任何症状，请立即寻求医疗帮助：</p>
<ul>
<li>胸痛</li>
</ul>
<ul>
<li>呼吸急促</li>
</ul>
<ul>
<li>感觉心跳加速、心悸或心脏剧烈跳动</li>
</ul>
<p>在 mNEXSPIKE 的临床试验中报告的副作用包括：</p>
<ul>
<li>注射部位反应：疼痛、压痛和同侧淋巴结肿大、肿胀（硬度）和红肿。</li>
</ul>
<ul>
<li>一般副作用：疲劳、头痛、肌肉疼痛、关节疼痛、寒战、恶心、呕吐和发热。</li>
</ul>
<p><strong>告知您的接种提供者您所有的医疗状况，包括如果您：</strong></p>
<ul>
<li>有任何过敏史</li>
</ul>
<ul>
<li>在接种过任何 COVID-19 疫苗后出现过严重过敏反应</li>
</ul>
<ul>
<li>曾患有心肌炎（心肌炎症）或心包炎（心脏外膜炎症）</li>
</ul>
<ul>
<li>有发热</li>
</ul>
<ul>
<li>有出血性疾病或正在服用抗凝药物</li>
</ul>
<ul>
<li>免疫系统受损或正在服用影响免疫系统的药物</li>
</ul>
<ul>
<li>怀孕或计划怀孕</li>
</ul>
<ul>
<li>正在哺乳</li>
</ul>
<ul>
<li>接种过任何其他 COVID-19 疫苗</li>
</ul>
<ul>
<li>曾在注射时晕厥过</li>
</ul>
<p>这些可能不是 mNEXSPIKE 的所有可能副作用。请向您的医疗保健提供者询问任何让您担忧的副作用。您可以通过 <strong>疫苗不良事件报告系统 (VAERS)</strong> 报告副作用，电话是 1-800-822-7967 或访问 http://vaers.hhs.gov。</p>
<p>请点击查看 mNEXSPIKE 完整处方信息。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含根据 1995 年《私人证券诉讼改革法》及其修正案的定义的前瞻性声明，包括关于：mNEXSPIKE 的有效性、安全性和耐受性；以及 Moderna 在 2025-2026 赛季的呼吸道疫苗的可用性。本新闻稿中的前瞻性声明既不是承诺也不是保证，您不应对这些前瞻性声明过度依赖，因为它们涉及已知和未知的风险、不确定性以及其他因素，其中许多超出了 Moderna 的控制范围，并可能导致实际结果与这些前瞻性声明所表达或暗示的结果有实质性差异。这些风险、不确定性和其他因素包括但不限于在 Moderna 2024 财年截至 12 月 31 日的 10-K 表格年报中以及 Moderna 随后向美国证券交易委员会提交的文件中描述的 “风险因素” 部分，这些文件可在 SEC 的网站 www.sec.gov 上获取。除法律要求外，Moderna 不承担更新或修订本新闻稿中包含的任何前瞻性声明的意图或责任，尤其是在出现新信息、未来发展或其他情况下。这些前瞻性声明基于 Moderna 当前的预期，仅在本新闻稿日期时有效。</p>
<p><strong>Moderna 联系人</strong></p>
<p>媒体：</p>
<p>Chris Ridley</p>
<p>全球媒体关系负责人</p>
<p>+1 617-800-3651</p>
<p>Chris.Ridley@modernatx.com</p>
<p>投资者：</p>
<p>Lavina Talukdar</p>
<p>高级副总裁兼投资者关系负责人</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>来源：</strong> Moderna, Inc.</p>
<p>查看原始新闻稿请访问 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. 已获得 FDA 对其 COVID-19 疫苗 mNEXSPIKE 的批准，针对 65 岁及以上的成年人以及 12 至 64 岁有基础健康风险的个体。这标志着 Moderna 的第三款 FDA 批准产品。该批准基于一项 III 期试验，显示 mNEXSPIKE 的有效性比其前身 mRNA-1273 高出 9.3%，且安全性相似。mNEXSPIKE 预计将在 2025-2026 年呼吸道病毒季节上市。Moderna 继续在 mRNA 医药开发领域处于领先地位，专注于各种疾病的创新治疗</p>

<p><em><strong>mNEXSPIKE becomes Moderna's third FDA-approved product</strong></em></p>
<div class="lb-trans"><p><em><strong>mNEXSPIKE 成为 Moderna 第三款获得 FDA 批准的产品</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.（纳斯达克代码：MRNA）今天宣布，美国食品药品监督管理局（FDA）已批准 mNEXSPIKE <strong>®</strong>（mRNA-1283），这是一种针对 COVID-19 的新疫苗，适用于所有 65 岁及以上的成年人，以及 12 至 64 岁之间具有至少一个或多个基础风险因素的个体，具体定义由疾病控制与预防中心（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 批准我们的第三款产品 mNEXSPIKE，为保护高风险严重疾病的 COVID-19 患者提供了一个重要的新工具，&#34;Moderna 首席执行官 Stéphane Bancel 表示。&#34;COVID-19 仍然是一个严重的公共卫生威胁，仅去年就有超过 47,000 名美国人死于该病毒。我们感谢 FDA 的及时审查，并感谢整个 Moderna 团队的辛勤工作和对公共卫生的持续承诺。&#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 对 mNEXSPIKE 的批准基于一项随机、观察者盲法、主动对照的三期临床试验结果（ClinicalTrials.gov 标识符：NCT05815498），该试验招募了约 11,400 名年龄在 12 岁及以上的参与者。本研究的主要有效性目标是证明 mNEXSPIKE 在接种后 14 天开始对 COVID-19 的疫苗有效性不劣于对照疫苗 mRNA-1273（Spikevax®），即 Moderna 的原始 COVID-19 疫苗。参与者接受了 10 微克的 mRNA-1283 或 50 微克的 mRNA-1273。mRNA-1283 在 12 岁及以上个体中显示出相对于 mRNA-1273 高出 9.3% 的相对疫苗有效性（rVE），在描述性亚组分析中，65 岁及以上成年人中 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>在三期试验中，mRNA-1283 的安全性与 mRNA-1273 相似，局部反应较少，系统反应相当。最常见的副作用包括注射部位疼痛、疲劳、头痛和肌肉疼痛。</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 预计将在 2025-2026 呼吸病毒季节为符合条件的人群提供 mNEXSPIKE，与 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 正在全球多个市场接受监管审查。</p>
</div><p><strong>About Moderna</strong></p>
<div class="lb-trans"><p><strong>关于 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 医学领域的领导者。通过推进 mRNA 技术，Moderna 正在重新构想药物的制造方式，并改变我们治疗和预防疾病的方式。公司在科学、技术和健康的交汇点上工作超过十年，开发出前所未有的速度和效率的药物，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 平台使得针对传染病、免疫肿瘤学、罕见疾病和自身免疫疾病的治疗和疫苗的开发成为可能。凭借独特的文化和全球团队，Moderna 致力于通过 mRNA 药物为人类健康的未来负责任地带来最大的影响。有关 Moderna 的更多信息，请访问 modernatx.com，并在 X（前身为 Twitter）、Facebook、Instagram、YouTube 和 LinkedIn 上与我们联系。</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 的注册商标。</p>
</div><p><strong>INDICATION</strong></p>
<div class="lb-trans"><p><strong>适应症</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 是一种保护人们免受 COVID-19 的疫苗。mNEXSPIKE 适用于之前接种过 COVID-19 疫苗的人群，且符合以下条件：</p>
</div><p>• 65 years of age and older, or</p>
<div class="lb-trans"><p>• 65 岁及以上，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 岁至 64 岁之间，且面临严重 COVID-19 的高风险。</p>
</div><p>Vaccination with mNEXSPIKE may not protect all people who receive the vaccine.</p>
<div class="lb-trans"><p>接种 mNEXSPIKE 可能无法保护所有接种疫苗的人。</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>如果您曾在接种过 mNEXSPIKE、SPIKEVAX（COVID-19 疫苗，mRNA）或任何 Moderna COVID-19 疫苗后出现严重过敏反应，则不应接种 mNEXSPIKE。</strong></p>
</div><p><strong>What are the risks of mNEXSPIKE?</strong></p>
<div class="lb-trans"><p><strong>mNEXSPIKE 的风险是什么？</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 可能导致严重过敏反应的几率非常小。严重过敏反应通常会在接种 mNEXSPIKE 后几分钟到 1 小时内发生。因此，您的医疗提供者可能会要求您在接种疫苗的地方稍作停留。严重过敏反应的迹象包括：</p>
</div><ul>
<li>Trouble breathing</li>
</ul>
<div class="lb-trans"><ul>
<li>呼吸困难</li>
</ul>
</div><ul>
<li>Swelling of your face and throat</li>
</ul>
<div class="lb-trans"><ul>
<li>面部和喉咙肿胀</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>头晕和虚弱</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>在接种 mRNA COVID-19 疫苗的某些人中，已发生心肌炎（心肌炎症）和心包炎（心脏外膜炎症）。接种 mRNA COVID-19 疫苗后，心肌炎和心包炎在 12 岁至 24 岁男性中最为常见。如果您或您的孩子在接种疫苗后，特别是在接种疫苗后的两周内出现以下任何症状，请立即寻求医疗帮助：</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>感觉心跳加速、心悸或心脏剧烈跳动</li>
</ul>
</div><p>Side effects that have been reported in clinical trials with mNEXSPIKE include:</p>
<div class="lb-trans"><p>在 mNEXSPIKE 的临床试验中报告的副作用包括：</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>注射部位反应：疼痛、压痛和同侧淋巴结肿大、肿胀（硬度）和红肿。</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：疲劳、头痛、肌肉疼痛、关节疼痛、寒战、恶心、呕吐和发热。</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>告知您的接种提供者您所有的医疗状况，包括如果您：</strong></p>
</div><ul>
<li>have any allergies</li>
</ul>
<div class="lb-trans"><ul>
<li>有任何过敏史</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>在接种过任何 COVID-19 疫苗后出现过严重过敏反应</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（心脏外膜炎症）</li>
</ul>
</div><ul>
<li>have a fever</li>
</ul>
<div class="lb-trans"><ul>
<li>有发热</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药物</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>免疫系统受损或正在服用影响免疫系统的药物</li>
</ul>
</div><ul>
<li>are pregnant or plan to become pregnant</li>
</ul>
<div class="lb-trans"><ul>
<li>怀孕或计划怀孕</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>接种过任何其他 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>曾在注射时晕厥过</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>这些可能不是 mNEXSPIKE 的所有可能副作用。请向您的医疗保健提供者询问任何让您担忧的副作用。您可以通过 <strong>疫苗不良事件报告系统 (VAERS)</strong> 报告副作用，电话是 1-800-822-7967 或访问 http://vaers.hhs.gov。</p>
</div><p>Please click for mNEXSPIKE Full Prescribing Information.</p>
<div class="lb-trans"><p>请点击查看 mNEXSPIKE 完整处方信息。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</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>本新闻稿包含根据 1995 年《私人证券诉讼改革法》及其修正案的定义的前瞻性声明，包括关于：mNEXSPIKE 的有效性、安全性和耐受性；以及 Moderna 在 2025-2026 赛季的呼吸道疫苗的可用性。本新闻稿中的前瞻性声明既不是承诺也不是保证，您不应对这些前瞻性声明过度依赖，因为它们涉及已知和未知的风险、不确定性以及其他因素，其中许多超出了 Moderna 的控制范围，并可能导致实际结果与这些前瞻性声明所表达或暗示的结果有实质性差异。这些风险、不确定性和其他因素包括但不限于在 Moderna 2024 财年截至 12 月 31 日的 10-K 表格年报中以及 Moderna 随后向美国证券交易委员会提交的文件中描述的 “风险因素” 部分，这些文件可在 SEC 的网站 www.sec.gov 上获取。除法律要求外，Moderna 不承担更新或修订本新闻稿中包含的任何前瞻性声明的意图或责任，尤其是在出现新信息、未来发展或其他情况下。这些前瞻性声明基于 Moderna 当前的预期，仅在本新闻稿日期时有效。</p>
</div><p><strong>Moderna Contacts</strong></p>
<div class="lb-trans"><p><strong>Moderna 联系人</strong></p>
</div><p>Media:</p>
<div class="lb-trans"><p>媒体：</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>全球媒体关系负责人</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>投资者：</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>高级副总裁兼投资者关系负责人</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>来源：</strong> Moderna, Inc.</p>
</div><p>View the original press release on ACCESS Newswire</p>
<div class="lb-trans"><p>查看原始新闻稿请访问 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 获得美国 FDA 批准其 COVID-19 疫苗 mNEXSPIKE | MRNA 股票新闻