莫德纳将多项疫苗计划推进后期临床试验-动脉网

Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials

BioSpace 等信源发布 2024-03-27 18:43

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Announces next-generation COVID-19 vaccine candidate as fourth respiratory vaccine to successfully meet its Phase 3 endpoints

宣布下一代新型冠状病毒肺炎候选疫苗为第四种呼吸道疫苗，以成功达到其3期终点

Expects two more Phase 3 readouts in 2024, including combination vaccine against flu and COVID-19, and vaccine against CMV

预计2024年还会有两个第三阶段的读数，包括针对流感和新型冠状病毒的联合疫苗，以及针对巨细胞病毒的疫苗

Announces positive clinical trial data from three new vaccines against viruses that cause significant burden (Epstein-Barr virus, Varicella-Zoster virus, norovirus) and advances programs toward Phase 3 development

宣布三种针对造成重大负担的病毒（爱泼斯坦-巴尔病毒、水痘-带状疱疹病毒、诺如病毒）的新疫苗的阳性临床试验数据，并推动项目朝着第三阶段发展

Anticipates U.S. launch of vaccine against RSV following FDA approval and ACIP recommendation in 2024

预计美国将在2024年FDA批准和ACIP建议后推出RSV疫苗

Announces development and commercialization funding agreement with Blackstone Life Sciences for up to $750 million to advance flu program

宣布与Blackstone Life Sciences签署开发和商业化资金协议，以推进流感计划，金额高达7.5亿美元

CAMBRIDGE, MA / ACCESSWIRE / March 27, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced at its fifth Vaccines Day event clinical and program updates demonstrating advancement and acceleration of its mRNA pipeline. The updates include data readouts in the Company's respiratory and latent and other vaccine portfolios, as well as commercial, manufacturing and financial announcements for its vaccines business..

马萨诸塞州剑桥/ACCESSWIRE/2024年3月27日/Moderna，Inc.（纳斯达克：MRNA）今天在其第五次疫苗日活动临床和计划更新中宣布，展示了其MRNA管道的进步和加速。更新内容包括该公司呼吸和潜伏疫苗及其他疫苗组合的数据读数，以及其疫苗业务的商业、制造和财务公告。。

'Our mRNA platform continues a remarkable track record across our broad vaccine portfolio. Today, we are excited to share that four vaccines in our pipeline have achieved successful clinical readouts across our respiratory, latent and other virus franchises,' said Stéphane Bancel, Chief Executive Officer of Moderna.

“我们的mRNA平台在我们广泛的疫苗组合中继续保持着卓越的业绩记录。Moderna首席执行官斯特凡·班塞尔（StéphaneBancel）说，今天，我们很高兴与大家分享，我们正在研发的四种疫苗在呼吸、潜伏和其他病毒领域取得了成功的临床读数。

'With five vaccines in Phase 3, and three more moving toward Phase 3, we have built a very large and diverse portfolio addressing significant unmet medical needs. We are focused on execution to further build momentum across our pipeline and business, and to deliver for patients who are impacted by these infectious diseases.'.

“第三阶段有五种疫苗，第三阶段还有三种疫苗，我们已经建立了一个非常庞大和多样化的组合，以解决重大的未满足的医疗需求。我们专注于执行，以进一步在我们的管道和业务中建立势头，并为受这些传染病影响的患者提供服务。”。

Portfolio Overview

投资组合概述

The vaccine portfolio seeks to address infectious diseases that cause considerable health burdens and includes 28 vaccines addressing respiratory, latent and other pathogens.

疫苗组合旨在解决造成相当大健康负担的传染病，包括28种针对呼吸道，潜伏性和其他病原体的疫苗。

Latent and Other Vaccine Portfolio

潜伏疫苗和其他疫苗组合

Moderna is advancing five vaccine candidates against viruses that cause latent infections, all of which are in clinical trials. When latent, a virus is present in the body but exists in a resting state, typically without causing any noticeable symptoms. Latent viruses can reactivate and cause clinical symptoms as a person ages, during times of stress or when immunity is compromised.

Moderna正在开发五种针对引起潜伏感染的病毒的候选疫苗，所有这些都在临床试验中。潜伏时，病毒存在于体内，但处于静止状态，通常不会引起任何明显症状。随着年龄的增长，在压力时期或免疫力受损时，潜伏病毒可以重新激活并引起临床症状。

The capacity for latency is a deﬁning feature of members of the Herpesviridae family, including cytomegalovirus (CMV), Epstein-Barr virus (EBV), herpes simplex virus (HSV) and Varicella-Zoster virus (VZV)..

潜伏期的能力是疱疹病毒科成员的一个定义特征，包括巨细胞病毒（CMV），爱泼斯坦-巴尔病毒（EBV），单纯疱疹病毒（HSV）和水痘-带状疱疹病毒（VZV）。。

Cytomegalovirus (CMV)

巨细胞病毒（CMV）

CMV is the most common infectious cause of birth defects in the U.S. and is responsible for several billion dollars in annual healthcare costs. One in 200 babies in the U.S. are born with a congenital CMV infection, and of those affected, one in five will have severe, life-altering health problems. Possible short- and long-term sequelae of CMV infection include microcephaly, chorioretinitis, seizures, sensorineural hearing loss, cognitive impairment and cerebral palsy.

巨细胞病毒是美国出生缺陷最常见的传染原因，每年造成数十亿美元的医疗费用。在美国，每200名婴儿中就有一名出生时患有先天性巨细胞病毒感染，在受感染的婴儿中，每五名婴儿中就有一名患有严重的、改变生命的健康问题。巨细胞病毒感染可能的短期和长期后遗症包括小头畸形，脉络膜视网膜炎，癫痫发作，感觉神经性听力损失，认知障碍和脑瘫。

There is currently no approved vaccine to prevent congenital CMV..

目前还没有批准的疫苗来预防先天性巨细胞病毒。。

CMVictory is a pivotal Phase 3 trial evaluating mRNA-1647 against primary CMV infection in women 16 to 40 years of age. The trial is a randomized, observer-blind, placebo-controlled study designed to evaluate the efficacy, safety and immunogenicity of mRNA-1647. The trial is fully enrolled with approximately 7,300 participants from 290 clinical sites globally..

CMVictory是一项关键的3期试验，评估mRNA-1647对16至40岁女性原发性CMV感染的影响。该试验是一项随机，观察者盲，安慰剂对照研究，旨在评估mRNA-1647的疗效，安全性和免疫原性。该试验已全部注册，来自全球290个临床地点的约7300名参与者。。

To date, 50 primary infection cases have accrued and are undergoing confirmation. The first interim analysis for the evaluation of vaccine efficacy, which will be triggered when both 81 confirmed per-protocol cases and 12 median months of safety follow-up have occurred, is expected as early as the end of 2024..

迄今为止，已有50例原发感染病例累积并正在确认中。预计最早将于2024年底进行疫苗效力评估的第一次中期分析，该分析将在81例确诊的按方案病例和12个月的中位安全随访发生时触发。。

Moderna's CMV vaccine candidate mRNA-1647 has advanced to indication expansion studies in adolescents 9 to 15 years of age and adult transplant patients, both of which have begun enrollment.

Moderna的巨细胞病毒候选疫苗mRNA-1647已经在9至15岁的青少年和成人移植患者中进行了适应症扩展研究，这两项研究都已经开始招募。

Epstein-Barr virus (EBV)

爱泼斯坦-巴尔病毒（EBV）

EBV is a major cause of infectious mononucleosis (IM) in the U.S., accounting for more than 90% of IM cases annually. Importantly, EBV and IM are associated with a higher lifetime risk of more serious sequelae including certain cancers such as gastric carcinoma, nasopharyngeal carcinoma and multiple types of lymphoma.

EBV是美国传染性单核细胞增多症（IM）的主要原因，每年占IM病例的90%以上。重要的是，EBV和IM与更严重后遗症的终生风险相关，包括某些癌症，如胃癌，鼻咽癌和多种类型的淋巴瘤。

The lifetime risk of developing multiple sclerosis (MS) is increased by 32-fold after EBV infection. There is currently no approved vaccine to prevent EBV..

EBV感染后，患多发性硬化症（MS）的终生风险增加了32倍。目前还没有批准的疫苗来预防EBV。。

Moderna's EBV vaccine candidates are designed to tackle multiple EBV-associated conditions, including prevention of IM (mRNA-1189) and MS and post-transplant lymphoproliferative disorder, a subcategory of lymphoma in solid organ transplant patients (mRNA-1195). The Phase 1 trial for mRNA-1189 was designed to test the safety, reactogenicity and immunogenicity of four different dose levels in participants 12 to 30 years of age in the U.S.

Moderna的EBV候选疫苗旨在解决多种EBV相关疾病，包括预防IM（mRNA-1189）和MS以及移植后淋巴增生性疾病，这是实体器官移植患者淋巴瘤的一个亚类（mRNA-1195）。mRNA-1189的第一阶段试验旨在测试美国12至30岁参与者中四种不同剂量水平的安全性，反应原性和免疫原性。

The randomized, observer-blind, placebo-controlled study showed mRNA-1189 was immunogenic and generally well tolerated across all dose levels. The Company is advancing mRNA-1189 toward a pivotal Phase 3 trial..

这项随机，观察者盲，安慰剂对照的研究表明，mRNA-1189具有免疫原性，并且在所有剂量水平上都具有良好的耐受性。该公司正在推进mRNA-1189进入关键的3期试验。。

The Phase 1 trial for mRNA-1195 was designed to test the safety, reactogenicity and immunogenicity of two drug products at four different dose levels in healthy EBV seropositive participants 18 to 55 years of age in the U.S. The randomized, observer-blind, placebo-controlled study is fully enrolled..

mRNA-1195的第一阶段试验旨在测试美国18至55岁健康EBV血清阳性参与者中两种药物在四种不同剂量水平下的安全性，反应原性和免疫原性。这项随机，观察者盲，安慰剂对照研究已全部入组。。

Herpes simplex virus (HSV)

单纯疱疹病毒（HSV）

Herpes simplex virus type 2 (HSV-2) infects approximately 13% of adults globally and is the primary cause of genital herpes. There are an estimated four billion people globally infected with HSV, of which 491 million cases are HSV-2. Recurrent genital herpes causes a reduction in quality of life, which antivirals (current standard of care) only partially restore.

单纯疱疹病毒2型（HSV-2）感染全球约13%的成年人，是生殖器疱疹的主要原因。据估计，全球有40亿人感染了HSV，其中4.91亿例是HSV-2。复发性生殖器疱疹导致生活质量下降，抗病毒药物（目前的护理标准）只能部分恢复。

Moderna expects that if an HSV vaccine candidate could deliver similar efficacy as a suppressive antiviral treatment, compliance with recommended therapy and associated quality of life would improve. There is currently no approved vaccine to treat HSV-2..

Moderna预计，如果HSV候选疫苗可以提供与抑制性抗病毒治疗相似的疗效，那么对推荐治疗的依从性和相关的生活质量将得到改善。目前还没有批准的疫苗来治疗HSV-2。。

The first in human, fully enrolled Phase 1/2 trial of mRNA-1608 is designed to test safety and immunogenicity and to establish a proof-of-concept of clinical benefit in adults 18 to 55 years of age with recurrent HSV-2 genital herpes. The randomized 1:1:1:1, observer-blind, controlled study is fully enrolled with 300 participants in the U.S..

mRNA-1608的首次人体完全登记的1/2期临床试验旨在测试安全性和免疫原性，并为18至55岁复发性HSV-2生殖器疱疹的成年人建立临床益处的概念验证。这项随机1:1:1:1，观察者盲，对照研究在美国有300名参与者。。

Varicella-Zoster virus (VZV)

水痘带状疱疹病毒（VZV）

Herpes zoster, also known as shingles, is caused by reactivation of latent VZV, the same virus that causes chickenpox. Declining immunity in older adults decreases immunity against VZV, allowing reactivation of the virus from latently infected neurons, causing painful and itchy lesions. Herpes Zoster occurs in one out of three adults in the U.S.

带状疱疹，也称为带状疱疹，是由潜伏性VZV（引起水痘的同一种病毒）的再激活引起的。老年人免疫力下降会降低对VZV的免疫力，从而使病毒从潜伏感染的神经元中重新激活，引起疼痛和瘙痒的病变。带状疱疹发生在美国三分之一的成年人中。

in their lifetime and the incidence increases at 50 years of age. There is potential to reach a growing and underserved patient population..

在他们的一生中，发病率在50岁时增加。有可能接触到不断增长且服务不足的患者群体。。

Moderna's VZV vaccine candidate mRNA-1468 has initial data available from a Phase 1/2 trial, which was designed to test safety and immunogenicity in healthy adults 50 years of age and older in the U.S. The randomized 1:1:1:1:1, observer-blind, active-controlled study of mRNA-1468 elicited strong antigen-specific T cell responses at one month after the second dose and was generally well tolerated.

Moderna的VZV候选疫苗mRNA-1468具有可从1/2期试验获得的初始数据，该试验旨在测试美国50岁及以上健康成年人的安全性和免疫原性。随机1:1:1:1:1，观察者盲，主动对照研究mRNA-1468在第二剂后一个月引发强烈的抗原特异性T细胞应答，并且通常耐受性良好。

Results of the first interim analysis support the further clinical development of mRNA-1468 for the prevention of shingles. Additional results from the ongoing Phase 1/2 study will be available later this year, including persistence data. The Company is planning for a pivotal Phase 3 trial..

第一次中期分析的结果支持mRNA-1468预防带状疱疹的进一步临床开发。正在进行的1/2期研究的其他结果将于今年晚些时候提供，包括持久性数据。该公司正计划进行关键的第三阶段试验。。

Norovirus

诺如病毒

Enteric viruses, including norovirus, are a leading cause of diarrheal diseases, resulting in significant morbidity and mortality worldwide, particularly among young children and older adults. Norovirus is highly contagious and a leading cause of diarrheal disease globally, associated with 18% of all acute gastroenteritis (AGE), resulting in approximately 200,000 deaths per year and substantial healthcare costs.

包括诺如病毒在内的肠道病毒是腹泻病的主要原因，在世界范围内导致了严重的发病率和死亡率，特别是在幼儿和老年人中。诺如病毒具有高度传染性，是全球腹泻病的主要原因，占所有急性胃肠炎（AGE）的18%，每年约有200000人死亡，医疗费用巨大。

Given the wide diversity of norovirus genotypes, a broadly effective norovirus vaccine will require a multivalent vaccine design. There is currently no approved vaccine to prevent norovirus..

鉴于诺如病毒基因型的多样性，广泛有效的诺如病毒疫苗将需要多价疫苗设计。目前还没有批准的疫苗来预防诺如病毒。。

The randomized, observer-blind, placebo-controlled Phase 1 trial was designed to evaluate the safety, reactogenicity and immunogenicity of trivalent (mRNA-1403) and pentavalent (mRNA-1405) norovirus vaccine candidates in 664 participants 18 to 49 years of age and 60 to 80 years of age in the U.S. An interim analysis showed that a single dose of mRNA-1403 elicited a robust immune response across all dose levels evaluated with a clinically acceptable reactogenicity and safety profile.

这项随机，观察者盲，安慰剂对照的1期临床试验旨在评估664名18至49岁和60至80岁的参与者中三价（mRNA-1403）和五价（mRNA-1405）诺如病毒候选疫苗的安全性，反应原性和免疫原性。一项中期分析显示，单剂量的mRNA-1403在所有剂量水平上均能引发强烈的免疫反应，并具有临床可接受的反应原性和安全性。

The Company is advancing mRNA-1403 toward a pivotal Phase 3 trial..

该公司正在将mRNA-1403推进关键的3期试验。。

Respiratory Vaccine Portfolio

呼吸道疫苗组合

Moderna's approach to ease the global burden of respiratory infections includes vaccine candidates against major causative pathogens, including SARS-CoV-2, respiratory syncytial virus (RSV) and influenza virus. Respiratory infections are a top cause of death in the U.S. and are particularly harmful to the young, immunocompromised, and older adults who experience more severe illness, greater incidence of hospitalization, and greater mortality than younger adults..

Moderna减轻全球呼吸道感染负担的方法包括针对主要致病病原体的候选疫苗，包括SARS-CoV-2，呼吸道合胞病毒（RSV）和流感病毒。呼吸道感染是美国的主要死亡原因，对年轻人、免疫力低下的人和老年人尤其有害，他们的疾病更严重，住院率更高，死亡率比年轻人更高。。

Moderna's respiratory pipeline includes Phase 3 trials for investigational vaccines including a next-generation COVID-19 vaccine, an RSV vaccine, a flu vaccine, and a flu and COVID-19 combination vaccine. The pipeline includes three additional flu vaccine candidates with expanded antigen coverage as well as combination vaccine programs..

Moderna的呼吸管道包括研究性疫苗的3期试验，包括下一代新型冠状病毒疫苗、RSV疫苗、流感疫苗以及流感和新型冠状病毒联合疫苗。该管道包括三种额外的流感候选疫苗，它们具有扩大的抗原覆盖范围以及联合疫苗计划。。

COVID-19

新型冠状病毒肺炎

Moderna continues to address the needs of the endemic COVID-19 market by focusing on public health efforts to increase vaccination coverage rates to reduce the substantial burden of COVID-19 as well as by advancing next-generation vaccines. The Company's mRNA platform can produce variant-matched vaccines on an accelerated time horizon, consistent with recent U.S.

Moderna继续解决地方性新型冠状病毒肺炎市场的需求，重点关注公共卫生工作，以提高疫苗接种覆盖率，减轻新型冠状病毒肺炎的沉重负担，并推进下一代疫苗。该公司的mRNA平台可以在加速的时间范围内生产与变体匹配的疫苗，这与最近的美国一致。

Food and Drug Administration (FDA) comments on the timing of potential strain selection for the fall booster season..

美国食品和药物管理局（FDA）对秋季加强季节潜在菌株选择时间的评论。。

A recent announcement of positive interim results from the NEXTCove Phase 3 trial showed that mRNA-1283 elicited a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2 compared to mRNA-1273.222, Moderna's licensed COVID-19 vaccine. mRNA-1283 is designed to be refrigerator-stable and paves the way for a combination vaccine against influenza and COVID-19, mRNA-1083, enhancing the Company's overall respiratory portfolio.

NEXTCove 3期临床试验最近公布的阳性中期结果显示，与mRNA-1273.222（Moderna许可的新型冠状病毒肺炎疫苗）相比，mRNA-1283对Omicron BA.4/BA.5和SARS-CoV-2原始病毒株均产生了更高的免疫应答。mRNA-1283设计用于冰箱稳定，为流感和新型冠状病毒（COVID-19）mRNA-1083的联合疫苗铺平了道路，增强了公司的整体呼吸组合。

This is Moderna's fourth infectious disease vaccine program with Phase 3 data..

这是Moderna的第四个传染病疫苗计划，具有3期数据。。

Respiratory Syncytial Virus (RSV)

呼吸道合胞病毒（RSV）

RSV is the leading cause of respiratory illness in young children, and older adults are at increased risk relative to younger adults for severe outcomes. In addition to acute mortality and morbidity, RSV infection is associated with long-term sequelae such as asthma and impaired lung function in pediatric populations, and exacerbation of chronic obstructive pulmonary disease in older adults.

RSV是幼儿呼吸道疾病的主要原因，与年轻人相比，老年人的严重后果风险增加。除了急性死亡率和发病率外，RSV感染还与长期后遗症有关，例如儿科人群的哮喘和肺功能受损，以及老年人慢性阻塞性肺病的恶化。

Annually, there are approximately two million medically attended RSV infections and 58,000 to 80,000 hospitalizations in children younger than five years old in the U.S. In the U.S., each year there are up to 160,000 hospitalizations and 10,000 deaths in adults 65 years and older due to RSV. Across high-income countries in 2019, RSV caused an estimated 5.2 million cases, 470,000 hospitalizations and 33,000 in-hospital deaths in adults 60 years and older..

在美国，每年约有200万名接受医疗治疗的RSV感染者和5岁以下儿童的58000至80000例住院治疗。在美国，每年有多达160000例65岁及以上的成年人因RSV住院治疗，10000例死亡。2019年，在高收入国家，RSV导致60岁及以上的成年人估计520万例，470000例住院治疗和33000例院内死亡。。

mRNA-1345

Moderna's RSV vaccine candidate, mRNA-1345, is in an ongoing Phase 2/3, randomized, observer-blind, placebo-controlled case-driven trial (ConquerRSV) in adults over 60 years of age. In this study, approximately 37,000 participants from 22 countries were randomized 1:1 to receive one dose of mRNA-1345 or placebo..

Moderna的RSV候选疫苗mRNA-1345正在进行一项针对60岁以上成年人的2/3期随机、观察者盲、安慰剂对照病例驱动试验（ConquerRSV）。在这项研究中，来自22个国家的大约37000名参与者以1:1的比例随机接受一剂mRNA-1345或安慰剂。。

Based on positive data from the ConquerRSV trial, Moderna has filed for regulatory approvals for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease (RSV-LRTD) and acute respiratory disease (ARD) in adults over 60 years of age.

根据ConquerRSV试验的阳性数据，Moderna已申请监管部门批准mRNA-1345，用于预防60岁以上成年人的RSV相关下呼吸道疾病（RSV-LRTD）和急性呼吸道疾病（ARD）。

The trial met both its primary efficacy endpoints, with a vaccine efficacy (VE) of 83.7% (95.88% CI: 66.1%, 92.2%; p<0.0001) against RSV-LRTD as defined by two or more symptoms, and a VE of 82.4% (96.36% CI: 34.8%, 95.3%; p=0.0078) against RSV-LRTD defined by three or more symptoms. These data were published in the New England Journal of Medicine in December 2023..

该试验符合其主要疗效终点，对两种或两种以上症状定义的RSV-LRTD的疫苗效力（VE）为83.7%（95.88%CI:66.1%，92.2%；p＜0.0001），对三种或三种以上症状定义的RSV-LRTD的疫苗效力（VE）为82.4%（96.36%CI:34.8%，95.3%；p＝0.0078）。这些数据于2023年12月发表在《新英格兰医学杂志》上。。

A subsequent analysis from the ConquerRSV study with a longer median follow-up duration of 8.6 months (versus 3.7 months in the primary analysis), with a range of 15 days to 530 days, and including subjects from the Northern and Southern Hemispheres was recently presented at the RSVVW'24 conference.

最近在RSVVW'24会议上介绍了来自ConquerRSV研究的后续分析，中位随访时间较长，为8.6个月（而初步分析为3.7个月），范围为15天至530天，包括来自南北半球的受试者。

In this supplemental analysis, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% (95.88% CI: 48.7%, 73.7%) against RSV-LRTD including two or more symptoms. VE was 74.6% (95% CI: 50.7%, 86.9%) against RSV-LRTD with ≥2 symptoms, including shortness of breath and 63.0% (95% CI: 37.3%, 78.2%) against RSV-LRTD including three of more symptoms.

在此补充分析中，mRNA-1345维持了持久的疗效，对包括两种或两种以上症状的RSV-LRTD的持续VE为63.3%（95.88%CI:48.7%，73.7%）。对于包括呼吸急促在内的≥2种症状的RSV-LRTD，VE为74.6%（95%CI:50.7%，86.9%），对于包括3种以上症状的RSV-LRTD，VE为63.0%（95%CI:37.3%，78.2%）。

The stringent statistical criterion of the study, a lower bound on the 95% CI of >20%, continued to be met for both endpoints..

该研究的严格统计标准（95%可信区间的下限>20%）在两个终点都得到了满足。。

mRNA-1345 has been granted Breakthrough Therapy designation by the FDA for the prevention of RSV-LRTD in adults over 60 years of age. The Company is awaiting regulatory approvals and the U.S. ACIP recommendation in 2024.

mRNA-1345已被FDA授予突破性治疗指定，用于预防60岁以上成年人的RSV-LRTD。该公司正在等待监管部门的批准和2024年美国ACIP的建议。

Indication expansion studies for mRNA-1345

mRNA-1345的适应症扩展研究

mRNA-1345 has the potential to protect all vulnerable populations from RSV. Moderna has initiated multiple Phase 3 expansion studies in adults over 50 years of age to evaluate co-administration and revaccination. Additional trials (Phase 1 - Phase 3) have been initiated for high-risk adults, as well as maternal and pediatric populations.

mRNA-1345有可能保护所有易感人群免受RSV感染。Moderna已经在50岁以上的成年人中启动了多个3期扩展研究，以评估共同给药和重新接种。已经开始针对高危成年人以及孕产妇和儿科人群进行其他试验（第一阶段-第三阶段）。

Interim data from these studies could be available as early as 2024..

这些研究的中期数据最早可于2024年获得。。

Influenza (Flu)

流感（Flu）

Worldwide, influenza leads to 3-5 million severe cases of flu and 290,000-650,000 flu-related respiratory deaths annually. Two main types of influenza viruses (A and B) cause seasonal flu epidemics, and the influenza A viruses lead to most flu-related hospitalization in older adults.

在世界范围内，流感每年导致300-500万例严重流感病例和290000-650000例流感相关的呼吸道死亡。两种主要类型的流感病毒（A型和B型）引起季节性流感流行，甲型流感病毒导致老年人大多数与流感相关的住院治疗。

The Company has several seasonal influenza vaccine candidates in clinical development. Moderna's seasonal flu vaccine, mRNA-1010, demonstrated consistently acceptable safety and tolerability across three Phase 3 trials. In the most recent Phase 3 trial (P303), which was designed to test the immunogenicity and safety of an optimized vaccine composition, mRNA-1010 met all immunogenicity primary endpoints, demonstrating higher antibody titers compared to a currently licensed standard-dose flu vaccine.

该公司在临床开发中有几种季节性流感疫苗候选物。Moderna的季节性流感疫苗mRNA-1010在三个3期试验中表现出一致可接受的安全性和耐受性。在最近的3期试验（P303）中，旨在测试优化疫苗组合物的免疫原性和安全性，mRNA-1010符合所有免疫原性主要终点，与目前许可的标准剂量流感疫苗相比，显示出更高的抗体滴度。

In an older adult extension study of P303, mRNA-1010 is being studied against high dose Fluzone HD®; the trial is fully enrolled. The Company is in ongoing discussions with regulators and intends to file in 2024..

在P303的老年人扩展研究中，正在针对高剂量Fluzone HD®研究mRNA-1010；试验已全部登记。该公司正在与监管机构进行讨论，并计划于2024年提交。。

Combination Respiratory Vaccines

联合呼吸道疫苗

Moderna's combination vaccine candidates cover respiratory viruses associated with the largest disease burden in the category. The Phase 3 combination study of the Company's investigational combination vaccine against flu and COVID-19 (mRNA-1083) for adults aged 50 years and older is fully enrolled and data are expected in 2024.

Moderna的候选联合疫苗涵盖了该类疾病负担最大的呼吸道病毒。该公司针对50岁及以上成年人的流感和新型冠状病毒19（mRNA-1083）研究性联合疫苗的第三阶段联合研究已全部登记，预计数据将于2024年公布。

mRNA-1083 was granted Fast Track designation by the FDA in May 2023..

2023年5月，FDA授予mRNA-1083快速通道指定。。

Commercial Updates

商业更新

Respiratory viruses in addition to latent and other viruses represent large unmet or underserved medical needs, and the human and economic costs from these infectious diseases highlight the need for effective vaccines. To help address this need, Moderna expects multiple vaccine product launches in the next few years, each with significant addressable markets..

除了潜伏病毒和其他病毒外，呼吸道病毒还代表了大量未得到满足或服务不足的医疗需求，这些传染病的人力和经济成本突显了对有效疫苗的需求。为了帮助满足这一需求，Moderna预计未来几年将推出多种疫苗产品，每种产品都有重要的可寻址市场。。

The 2024 global endemic COVID-19 vaccine market alone is estimated by Moderna to be approximately $10 billion. COVID-19 continues to show a high burden of disease, and while COVID-19 hospitalizations remain high relative to RSV and flu, the risks of Long COVID are also becoming better understood. Moderna is focused on improving education and awareness to increase vaccination rates as Long COVID data suggests even traditionally low-risk groups should be vaccinated.

据Moderna估计，仅2024年全球地方性新型冠状病毒疫苗市场就约为100亿美元。新型冠状病毒继续显示出很高的疾病负担，虽然相对于RSV和流感，新型冠状病毒住院率仍然很高，但长期新型冠状病毒的风险也得到了更好的理解。只要新型冠状病毒数据表明，即使是传统上的低风险人群也应该接种疫苗，Moderna就专注于提高教育和意识，以提高疫苗接种率。

Moderna is also working with health authorities to align the timing of COVID-19 and flu vaccine launches to help improve public health..

Moderna还与卫生部门合作，调整新型冠状病毒和流感疫苗的推出时间，以帮助改善公众健康。。

For RSV, Moderna estimates the peak annual market to be approximately $10 billion. The Company expects a strong RSV vaccine launch into a large market in 2024. As the only mRNA investigational vaccine with positive Phase 3 data, Moderna's RSV vaccine candidate has a strong profile with consistently strong efficacy across vulnerable and older populations, a well-established safety and tolerability profile, and ease of administration with a ready-to-use, pre-filled syringe formulation, which could relieve some of the burden that falls on pharmacies during the fall vaccination season..

对于RSV，Moderna估计年峰值市场约为100亿美元。该公司预计2024年将有强大的RSV疫苗进入大型市场。作为唯一具有阳性3期数据的mRNA研究疫苗，Moderna的RSV候选疫苗在易感人群和老年人群中具有强大的效力，具有良好的安全性和耐受性，易于使用，预先填充的注射器配方，可以减轻秋季疫苗接种季节药房的一些负担。。

An interim analysis from an ongoing time and motion study evaluating differences in preparation time between a pre-filled syringe (PFS) presentation and vaccines that require reconstitution showed that a PFS presentation could relieve some of the burden that falls on pharmacies during the fall vaccination season.

一项正在进行的时间和运动研究的中期分析评估了预填充注射器（PFS）呈现与需要重建的疫苗之间的准备时间差异，结果表明，PFS呈现可以减轻秋季疫苗接种季节药房的一些负担。

Results from this study suggest that pharmacies may be capable of preparing up to four times as many doses of PFS in an hour compared to vaccines requiring reconstitution..

这项研究的结果表明，与需要重建的疫苗相比，药店可能能够在一小时内制备多达四倍剂量的PFS。。

Moderna estimates flu vaccines represent an approximately $7 billion market in 2024. The market is expected to grow with the rise of more effective vaccines and there is an opportunity to expand the market with next-generation premium flu vaccines as well as combination respiratory vaccines, adding increased value to the health ecosystem..

Moderna估计，2024年流感疫苗市场约为70亿美元。随着更有效疫苗的出现，市场预计会增长，有机会用下一代优质流感疫苗和呼吸道联合疫苗扩大市场，为健康生态系统增加价值。。

CMV is expected to be a $2-5 billion annual market. With no vaccine currently on the market and a potential vaccine launch in 2026, Moderna could be the first CMV vaccine in multi-billion-dollar latent vaccine market. In addition, EBV has the potential to address and reduce the burden and cost of EBV infection in multiple populations, while VZV provides the opportunity to enter a large and growing market, which could be $5-6 billion annually.

预计巨细胞病毒的年市场规模将达到20-50亿美元。由于目前市场上没有疫苗，2026年有可能推出疫苗，Moderna可能是数十亿美元潜在疫苗市场上的第一种CMV疫苗。此外，EBV有可能解决和减少多个人群中EBV感染的负担和成本，而VZV提供了进入一个巨大且不断增长的市场的机会，每年可能达到50-60亿美元。

The market for norovirus vaccines is similar to that of rotavirus in pediatrics with opportunity to expand into the adult population, and represents a $3-6 billion annual market..

诺如病毒疫苗的市场与儿科轮状病毒的市场相似，有机会扩展到成年人群，年市场规模为30-60亿美元。。

Moderna's vaccine portfolio targets large addressable markets, with an estimated total addressable market (TAM) of $52 billon for Moderna infectious disease vaccines, which includes a respiratory vaccines TAM of more than $27 billion and a latent and other vaccines TAM of more than $25 billion.

Moderna的疫苗组合针对大型可寻址市场，估计Moderna传染病疫苗的总可寻址市场（TAM）为520亿美元，其中包括超过270亿美元的呼吸道疫苗TAM和超过250亿美元的潜伏疫苗和其他疫苗TAM。

Manufacturing

制造业

The Company's manufacturing innovation supports expanding commercialization of a diverse pipeline through efficiency and productivity gains. Its mRNA manufacturing platform enables benefits such as quality, speed, scale and cost efficiency across a footprint that broadly includes the manufacture of plasmid, mRNA, lipid nanoparticles, as well as fill/finish and quality control capabilities..

该公司的制造创新支持通过提高效率和生产力来扩大多样化管道的商业化。其mRNA制造平台在广泛包括质粒，mRNA，脂质纳米颗粒的制造以及填充/完成和质量控制能力的足迹中实现了质量，速度，规模和成本效益等优势。。

As the Company continues to build its footprint for the future, it is developing an agile global manufacturing network to meet commercial demand and support its growing pipeline. Pre-clinical through commercial manufacturing occurs at the Moderna Technology Center in Norwood, Massachusetts, which remains central to the Company's network.

随着该公司继续为未来拓展业务，它正在开发一个灵活的全球制造网络，以满足商业需求并支持其不断增长的生产线。临床前通过商业制造发生在马萨诸塞州诺伍德的Moderna技术中心，该中心仍然是该公司网络的核心。

New facilities being constructed in Australia, Canada and the UK are expected to come online in 2025, and drug product capacity is achieved through a flexible contract manufacturing network. Additionally, the Company has purchased and started build-out of a manufacturing site in Marlborough, Massachusetts, to enable commercial scale of its individualized neoantigen therapy program..

澳大利亚、加拿大和英国正在建设的新设施预计将于2025年上线，药品生产能力将通过灵活的合同制造网络实现。此外，该公司已购买并开始在马萨诸塞州马尔伯勒的一个制造基地进行建设，以实现其个性化新抗原治疗计划的商业规模。。

By continuing to pioneer new technologies, including advanced robotics, applying AI and other digital solutions, and driving network and capital efficiency, Moderna's manufacturing network is expected to also drive more predictable cost of sales.

通过继续开拓新技术，包括先进的机器人技术，应用人工智能和其他数字解决方案，并推动网络和资本效率，预计Moderna的制造网络也将推动更可预测的销售成本。

Research and Development Investment Strategy

研发投资策略

Today's updates provide further evidence that Moderna's mRNA technology platform is working, and with a rate of success higher than industry standard. Looking ahead, research and development will continue to be the Company's top capital allocation priority.

今天的更新提供了进一步的证据，表明Moderna的mRNA技术平台正在工作，并且成功率高于行业标准。展望未来，研发将继续是公司的首要资本配置重点。

As Moderna looks to create value through the research and development strategy for its vaccine portfolio, it is taking three prioritization parameters into consideration: pipeline advancement, revenue diversification and risk reduction. As part of its strategy, the funding options Moderna considers are self-funding, project financing and partnerships..

随着Moderna寻求通过其疫苗组合的研发战略创造价值，它正在考虑三个优先参数：管道推进，收入多样化和风险降低。作为其战略的一部分，Moderna考虑的资金选择是自筹资金、项目融资和伙伴关系。。

Moderna recently entered into a development and commercialization funding agreement with Blackstone Life Sciences to advance the Company's flu program. As part of the agreement, Blackstone will fund up to $750 million with a return based on cumulative commercial milestones and low-single digit royalties.

Moderna最近与Blackstone Life Sciences签订了一项开发和商业化资助协议，以推进该公司的流感项目。作为协议的一部分，黑石集团将提供高达7.5亿美元的资金，回报率基于累积的商业里程碑和低个位数的版税。

Moderna expects to recognize the funding as a reduction in research and development expenses and will retain full rights and control of the Company's flu program. This funding does not result in any change to Moderna's 2024 research and development framework of approximately $4.5 billion..

摩德纳希望将这笔资金视为研发费用的减少，并将保留该公司流感项目的全部权利和控制权。这笔资金不会导致Moderna 2024年大约45亿美元的研发框架发生任何变化。。

About Moderna

关于Moderna

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..

Moderna是mRNA医学领域的领导者。通过mRNA技术的进步，Moderna正在重新想象药物的制造方式，并改变我们如何为每个人治疗和预防疾病。通过十多年来在科学、技术和健康的交叉点工作，该公司以前所未有的速度和效率开发了药物，包括最早和最有效的新型冠状病毒疫苗之一。。

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.

Moderna的mRNA平台为传染病、免疫肿瘤学、罕见病和自身免疫性疾病的治疗和疫苗的开发提供了支持。凭借独特的文化和由Moderna价值观和心态驱动的全球团队，以负责任的方式改变人类健康的未来，Moderna努力通过mRNA药物为人们带来最大的影响。

For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn..

有关Moderna的更多信息，请访问modernatx.com，并通过X（以前的Twitter）、Facebook、Instagram、YouTube和LinkedIn与我们联系。。

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 18 years of age and older.

SPIKEVAX（COVID-19疫苗，mRNA）是一种用于主动免疫的疫苗，可预防18岁及以上人群中由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

重要安全信息

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

不要给已知对疫苗的任何成分有严重过敏反应（例如过敏反应）史的个体服用。

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.

在接种疫苗后发生急性过敏反应的情况下，必须立即提供适当的药物治疗以管理即时过敏反应。

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age.

上市后数据显示，心肌炎和心包炎的风险增加，特别是在第二剂后7天内。观察到的40岁以下男性的风险高于女性和年龄较大的男性。观察到的风险在18至24岁的男性中最高。

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

晕厥（晕厥）可能与注射疫苗有关。应制定程序以避免晕厥造成伤害。

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人，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。

Adverse reactions reported in clinical trials following administration of the vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site, and rash..

接种疫苗后临床试验报告的不良反应包括注射部位疼痛、疲劳、头痛、肌痛、关节痛、寒战、恶心/呕吐、腋窝肿胀/压痛、发烧、注射部位肿胀、注射部位红斑和皮疹。。

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）在线报告某些不良事件，网址为https://vaers.hhs.gov/reportevent.html或者拨打1-800-822-7967。

Please see the SPIKEVAX Full Prescribing Information. For information regarding authorized emergency uses of the Moderna COVID-19 Vaccine, please see the EUA Fact Sheet.

请参阅SPIKEVAX完整的处方信息。有关授权紧急使用Moderna COVID-19疫苗的信息，请参阅EUA简报。

Spikevax® is a registered trademark of Moderna.

Spikevax®是Moderna的注册商标。

Fluzone® is a registered trademark of Sanofi Pasteur.

Fluzone®是赛诺菲巴斯德的注册商标。

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 statements regarding: the advancement of Moderna's programs under clinical development; the timing for anticipated approvals of vaccine candidates; the efficacy, safety and tolerability of vaccine candidates; the total addressable markets for programs under development; the efficiencies and advantages of Moderna's mRNA platform; future capital allocation and financing efforts; and anticipated spending for R&D in 2024.

本新闻稿包含1995年《私人证券诉讼改革法案》修订版所指的前瞻性声明，包括以下声明：在临床开发中推进Moderna的计划；预期批准候选疫苗的时间；候选疫苗的有效性，安全性和耐受性；正在开发的项目的总目标市场；Moderna mRNA平台的效率和优势；未来的资本分配和融资努力；以及2024年的预期研发支出。

In some cases, forward-looking statements can be identified by terminology such as 'will,' 'may,' 'should,' 'could,' 'expects,' 'intends,' 'plans,' 'aims,' 'anticipates,' 'believes,' 'estimates,' 'predicts,' 'potential,' 'continue,' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

在某些情况下，前瞻性陈述可以通过“意志”、“可能”、“应该”、“可能”、“预期”、“打算”、“计划”、“目标”、“预期”、“相信”、“估计”、“预测”、“潜力”、“继续”或这些术语或其他类似术语的否定词来识别，尽管并非所有前瞻性陈述都包含这些词。

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.

本新闻稿中的前瞻性声明既不是承诺也不是保证，您不应过度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，其中许多因素超出了Moderna的控制范围，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存在重大差异。

These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading 'Risk Factors' in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, 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Moderna向美国证券交易委员会（SEC）提交的截至2023年12月31日财政年度10-K表年度报告中“风险因素”标题下描述的风险和不确定性，以及Moderna随后向SEC提交的文件中描述的风险和不确定性，这些文件可在SEC网站www.SEC.gov上查阅。

Except as required by law, Moderna disclaims .

除法律要求外，Moderna不承担任何责任。

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Moderna Contacts

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Media:

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Chris Ridley

Head, Global Media Relations

全球媒体关系主管

+1 617-800-3651