莫德纳获得美国FDA批准新冠肺炎疫苗更新-动脉网

Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine

biospace 等信源发布 2023-09-11 09:18

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Clinical data show robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86

临床数据显示跨多种循环变体的强烈免疫应答，包括EG.5，FL.1.5.1和BA.2.86

Updated vaccine to be available in pharmacies and care settings across the U.S. in the coming days

更新的疫苗将在未来几天在美国的药房和护理机构提供

CAMBRIDGE, MA / ACCESSWIRE / September 11, 2023 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application(sBLA) for Spikevax® for ages 12 years and above. Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine was also received for individuals 6 months through 11 years of age.

CAMBRIDGE，MA/ACCESSWIRE/2023年9月11日/Moderna，Inc。（纳斯达克股票代码：MRNA）今天宣布，美国食品和药物管理局（FDA）已批准Spikevax®的补充生物制剂许可申请（sBLA）年龄在12岁及以上。Moderna COVID-19疫苗的紧急使用许可（EUA）也在6个月至11岁之间收到。

Moderna's updated COVID-19 vaccine contains spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. With the U.S. FDA's decision, Moderna will begin shipping doses to vaccination sites across the U.S., with updated vaccines expected to be available in the coming days..

Moderna更新的新型冠状病毒肺炎疫苗含有XBB.1.5 SARS-CoV-2亚系的刺突蛋白，有助于预防6个月及以上个体的新型冠状病毒肺炎。根据美国FDA的决定，Moderna将开始向美国各地的疫苗接种地点运送剂量，预计未来几天将有更新的疫苗。。

'COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season. As the primary circulating strain continues to evolve, updated vaccines will be critical to protecting the population this season,' said Stéphane Bancel, CEO of Moderna.

'COVID-19仍然是美国的主要死亡原因，对弱势群体构成重大威胁，特别是当我们进入呼吸道病毒高峰期时。Moderna首席执行官StéphaneBancel说，随着主要流行毒株的不断发展，更新疫苗对于本赛季保护人口至关重要。

'We appreciate the FDA's timely review and encourage individuals who intend to get their flu shot to also get their updated COVID-19 vaccine at the same time.'.

“我们感谢FDA的及时审查，并鼓励打算接种流感疫苗的个人同时获得更新的COVID-19疫苗。”。

In June 2023, the U.S. FDA advised that COVID-19 vaccines should be updated to a monovalent XBB.1.5 composition for the 2023 - 2024 vaccination season. At the June VRBPAC, Moderna presented clinical data showing that its updated vaccine resulted in robust immune responses across multiple XBB sublineages, including XBB.1.5 and XBB.1.16.

2023年6月，美国FDA建议将COVID-19疫苗更新为2023-2024疫苗接种季节的单价XBB.1.5组合物。在6月的VRBPAC中，Moderna提供了临床数据，显示其更新的疫苗在多个XBB亚系（包括XBB.1.5和XBB.1.16）中产生强烈的免疫应答。

In August, Moderna announced additional clinical trial data which showed the company's updated COVID-19 vaccine elicited an immune response in humans against EG.5 and FL.1.5.1, currently the dominant variants in the United States. Last week, the company shared additional clinical trial data confirming that the updated vaccine also elicited a human immune response against BA.2.86..

8月，Moderna宣布了额外的临床试验数据，显示该公司更新的COVID-19疫苗在人体内引发了针对EG.5和FL.1.5.1的免疫应答，目前这是美国的主要变种。上周，该公司分享了额外的临床试验数据，证实更新后的疫苗也引发了针对BA的人体免疫应答。。

The most common solicited local adverse event for Moderna's updated COVID-19 vaccine was injection site pain. The most common solicited systemic adverse events include headache, fatigue, myalgia and chills, which is consistent with previous formulations of Spikevax.

Moderna更新的COVID-19疫苗最常见的局部不良事件是注射部位疼痛。最常见的全身不良事件包括头痛，疲劳，肌痛和寒战，这与以前的Spikevax配方一致。

Outside the U.S., regulatory applications for Moderna's updated COVID-19 vaccine are under review by other regulatory agencies with decisions anticipated in the coming weeks.

在美国以外，Moderna更新的COVID-19疫苗的监管申请正在由其他监管机构进行审查，并在未来几周内做出决定。

About Moderna

关于现代人

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale.

自成立以来的10多年中，Moderna已从一家研究阶段的公司转变为信使RNA（mRNA）领域的项目，转变为一家拥有多种临床疫苗和治疗药物组合的企业，涵盖七种模式，广泛的知识产权组合和集成制造设施，可实现大规模的快速临床和商业生产。

Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic..

Moderna与广泛的国内外政府和商业合作者保持联盟，这使得追求开创性的科学和快速扩大的制造业成为可能。最近，Moderna的能力已经汇集在一起，可以授权使用和批准最早和最有效的针对COVID-19大流行的疫苗之一。。

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years.

Moderna的mRNA平台建立在基础和应用mRNA科学，传递技术和制造技术的不断进步的基础上，并允许开发传染病，免疫肿瘤学，罕见疾病，心血管疾病和自身免疫疾病的治疗和疫苗。Moderna在过去八年中被科学评为顶级生物制药雇主。

To learn more, visit www.modernatx.com..

AUTHORIZED USE IN THE U.S.

在美国授权使用。

Emergency uses of the Moderna COVID-19 Vaccine (2023-2024 Formula) have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) for use in individuals 6 months through 11 years of age.

Moderna COVID-19疫苗（2023-2024配方）的紧急用途尚未得到FDA的批准或许可，但已获得FDA的授权，根据紧急使用授权（EUA）在6个月至11个月的个人中使用岁。

INDICATION (U.S.)

指示（美国）

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

SPIKEVAX（COVID-19疫苗，mRNA）是一种用于主动免疫的疫苗，用于预防由12岁及以上的个体中的严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引起的2019年冠状病毒病（COVID-19）。

IMPORTANT SAFETY INFORMATION

重要的安全信息

Do not administer the vaccines to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

不要将疫苗给予已知对疫苗任何成分有严重过敏反应史（例如过敏反应）的个体。

Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

如果在接种疫苗后发生急性过敏反应，必须立即提供适当的药物治疗以控制即时过敏反应。

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination.

上市后数据显示心肌炎和心包炎的风险增加，特别是在接种疫苗后的第一周内。

Syncope (fainting) may occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.

晕厥（昏厥）可能与注射疫苗的使用有关。应制定程序以避免昏厥造成伤害。

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to the vaccine.

免疫功能低下的人，包括接受免疫抑制治疗的个体，可能对疫苗的反应减弱。

The vaccine may not protect all vaccine recipients.

疫苗可能无法保护所有疫苗接种者。

The most commonly reported (≥10%) adverse reactions following any dose were pain at the injection site, headache, fatigue, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, swelling at the injection site, erythema at the injection site, and fever.

任何剂量后最常报告的（≥10%）不良反应是注射部位疼痛，头痛，疲劳，肌痛，发冷，关节痛，腋窝肿胀/压痛，恶心/呕吐，注射部位肿胀，红斑注射部位和发烧。

The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967.

疫苗接种提供者负责向疫苗不良事件报告系统（VAERS）在线强制报告某些不良事件https://vaers.hhs.gov/reportevent.html或致电1-800-822-7967。

Please see the SPIKEVAX Full Prescribing Information.

请参阅SPIKEVAX完整的处方信息。

Please see the Moderna COVID-19 Vaccine (2023-2024 Formula) Fact Sheet for Healthcare Providers Administering Vaccine for more information.

请参阅用于管理疫苗的医疗保健提供者的Moderna COVID-19疫苗（2023-2024配方）情况说明书以获取更多信息。

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the ability of Moderna's updated COVID-19 vaccine to generate robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1 and BA.2.86, and to provide protection this season; Moderna's shipment of doses to vaccination sites across the U.S., and the availability of Moderna's updated vaccine in pharmacies and care settings across the U.S.

本新闻稿包含经修订的1995年“私人证券诉讼改革法案”含义范围内的前瞻性声明，包括：Moderna更新的COVID-19疫苗能够在多种循环变异体中产生强大的免疫反应，包括EG.5，FL.1.5.1和BA.2.86，并在本赛季提供保护；Moderna将剂量运送到美国各地的疫苗接种地点，以及Moderna在美国各地药房和护理机构提供最新疫苗的情况。

in the coming days; the ability of updated vaccines to protect against SARS-CoV-2 as the virus continues to evolve; and anticipated decisions in the coming weeks with respect to regulatory applications for Moderna's updated COVID-19 vaccine outside the U.S. 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.

在未来的日子里；随着病毒的不断发展，更新疫苗预防SARS-CoV-2的能力；未来几周关于Moderna在美国境外更新的COVID-19疫苗的监管申请的预期决定本新闻稿中的前瞻性声明既不承诺也不保证，您不应过分依赖这些前瞻性声明，因为它们涉及已知和未知的风险，不确定性和其他因素，其中许多超出了Moderna的控制范围，可能导致实际结果与这些前瞻性陈述所表达或暗示的结果大不相同。

These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading 'Risk Factors' in Moderna's Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov.

这些风险，不确定性和其他因素包括在向美国证券交易委员会（SEC）提交的2022年12月31日结束的年份Moderna的10-K年度报告标题“风险因素”中描述的其他风险和不确定性，以及Moderna与SEC随后提交的文件，可在SEC的网站www.SEC.gov上查阅。

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 develo.

除法律要求外，Moderna不承担任何意图或责任，以便在新信息，未来发展的情况下更新或修订本新闻稿中包含的任何前瞻性声明。

Moderna Contacts

现代接触

Media:

媒体：

Elise Meyer

Sr. Director, Corporate Communications

公司通讯总监

617-852-7041

Elise.Meyer@modernatx.com

Investors:

投资者：