预约演示
更新于：2026-04-24
mRNA-1083
更新于：2026-04-24
概要
基本信息
药物类型 预防性疫苗、mRNA疫苗 |
别名 Influenza and COVID-19 Vaccine(Moderna)、mRNA encoding haemagglutinin of B/Victoria lineage, haemagglutinin of influenza A/H1N1, haemagglutinin of influenza A/H3N2, SARS-CoV-2 spike protein NTD-RBD subdomains、mRNA 1083 + [3] |
作用方式 抑制剂、刺激剂 |
作用机制 SARS-CoV-2 S protein抑制剂(冠状病毒刺突糖蛋白抑制剂)、hemagglutinin抑制剂(血凝素抑制剂)、免疫刺激剂 |
非在研适应症- |
原研机构 |
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)- |
特殊审评儿科研究计划 (欧盟) |
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关联
5
项与 mRNA-1083 相关的临床试验NCT06864143
A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to <65 years of age.
开始日期2025-03-07 |
申办/合作机构 |
NCT06694389
A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adults ≥50 Years of Age
The purpose of the study is to evaluate the immunogenicity, reactogenicity, and safety of mRNA-1083 in adults 50 years of age and older in participating countries (Japan, Taiwan, and South Korea).
开始日期2024-11-18 |
申办/合作机构 |
NCT06508320
A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity in Relation to the Product Attributes of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Adults ≥50 to <65 Years of Age
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to <65 years of age.
开始日期2024-07-15 |
申办/合作机构 |
100 项与 mRNA-1083 相关的临床结果
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100 项与 mRNA-1083 相关的转化医学
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100 项与 mRNA-1083 相关的专利（医药）
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6
项与 mRNA-1083 相关的文献（医药）2025-06-10·JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years
Article
作者: Rudman Spergel, Amanda K. ; Urdaneta, Veronica ; Carmona, Lizbeth ; Girard, Bethany ; Miller, Jacqueline ; Mehta, Darshan ; Ananworanich, Jintanat ; Espinosa-Fernandez, Ivette ; Sinkiewicz, Melissa ; Shaw, Christine A. ; Deng, Weiping ; Paila, Yamuna D. ; Callendret, Benoit ; Johnson, Kimball ; Das, Rituparna ; Schaefers, Kristin ; Cardona, Jose ; Wu, Iris ; Kostanyan, Lusine
Importance:
Uptake of recommended seasonal influenza and COVID-19 vaccines remains suboptimal.
Objective:
To assess the immunogenicity and safety of an investigational mRNA-1083 vaccine against seasonal influenza and SARS-CoV-2 in adults 50 years and older.
Design, Setting, and Participants:
This phase 3, randomized, observer-blinded trial was conducted across 146 US sites in adults 50 years and older enrolled between October 19, 2023, and November 21, 2023. Data extraction was complete on April 9, 2024.
Interventions:
Participants in 2 age cohorts (≥65 years and 50-64 years) were randomly assigned (1:1) to receive mRNA-1083 plus placebo or coadministered licensed quadrivalent seasonal influenza (≥65 years: high-dose quadrivalent inactivated influenza vaccine [HD-IIV4]; 50-64 years: standard-dose IIV4 [SD-IIV4]) and COVID-19 (all ages: mRNA-1273) vaccines.
Main Outcomes and Measures:
The primary objectives were to demonstrate the noninferiority of humoral immune responses following mRNA-1083 vs comparators against vaccine-matched strains at day 29 and to evaluate the reactogenicity and safety of mRNA-1083. Secondary objectives included demonstration of superiority of humoral immune responses elicited by mRNA-1083 relative to comparators at day 29.
Results:
Overall, 8015 participants were enrolled and vaccinated (4017 aged ≥65 y and 3998 aged 50-64 y). Among adults 65 years and older and 50 to 64 years, the median age was 70 and 58 years, 54.2% and 58.8% were female, 18.4% and 26.7% were Black or African American, and 13.9% and 19.3% were Hispanic or Latino, respectively. Noninferior immunogenicity of mRNA-1083 was demonstrated against all vaccine-matched influenza and SARS-CoV-2 strains based on lower bound of the 97.5% CI of the geometric mean ratio greater than 0.667 and lower bound of the 97.5% CI of the seroconversion/seroresponse rate difference greater than −10%. mRNA-1083 elicited higher immune responses than SD-IIV4 (50-64 years) for all 4 influenza strains and HD-IIV4 (≥65 years) for 3 influenza strains (A/H1N1, A/H3N2, B/Victoria) and against SARS-CoV-2 (all ages). Solicited adverse reactions were numerically higher in frequency and severity after mRNA-1083 vaccination than comparators in both age cohorts (≥65 y: 83.5% and 78.1%; 50-64 y: 85.2% and 81.8%); most were grade 1 or 2 in severity and of short duration. No safety concerns were identified.
Conclusions and Relevance:
In this study, mRNA-1083 met noninferiority criteria and induced higher immune responses than recommended standard care influenza (standard and high dose) and COVID-19 vaccines against all 4 influenza strains (among those ages 50-64 y), the 3 clinically relevant influenza strains (among those aged ≥65 y), and SARS-CoV-2 (all ages), with an acceptable tolerability and safety profile.
Trial Registration:
ClinicalTrials.gov Identifier: NCT06097273
2025-05-01·NATURE MEDICINE
mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial
Article
作者: Paila, Yamuna D ; Henry, Carole ; Guo, Ruiting ; Eger, Charles H ; Deng, Weiping ; Sinkiewicz, Melissa ; Ananworanich, Jintanat ; Schaefers, Kristin ; Shaw, Christine A ; Rudman Spergel, Amanda K ; Shao, Sarah ; Carmona, Lizbeth ; Kandinov, Boris
A multicomponent vaccine targeting several seasonal respiratory pathogens may provide simultaneous protection in a single-injection regimen. We present interim (28 days) findings from a phase 1/2 study of an mRNA-based multicomponent vaccine (mRNA-1083), encoding seasonal influenza and SARS-CoV-2 antigens. Adults (18-79 years) were randomly assigned to receive different compositions of mRNA-1083 at varying dose levels on day 1. The primary study objectives were reactogenicity through 7 days and safety through 28 days postvaccination, and the secondary study objective was immunogenicity against vaccine-matched influenza and SARS-CoV-2 strains at day 29 assessed by hemagglutination inhibition and pseudovirus neutralization assays, respectively. The multicomponent mRNA-1083 vaccine was generally well-tolerated, with most solicited adverse reactions being Grade 1 or 2 in severity. The incidence of unsolicited adverse events was similar across vaccine groups. mRNA-1083 induced immune responses against influenza and SARS-CoV-2 that were, in general, similar to or higher than those achieved with licensed quadrivalent influenza (standard or high dose) and SARS-CoV-2 (bivalent mRNA-1273) vaccines. These data support ongoing phase 3 evaluation of the mRNA-1083 vaccine. ClinicalTrials.gov registration: NCT05827926 .
2023-12-08·Emerging microbes & infections
Rational design of an influenza-COVID-19 chimeric protective vaccine with HA-stalk and S-RBD
Article
作者: Zhang, Rong ; Lu, Xuancheng ; Xu, Ke ; Wang, Xi ; Bi, Yuhai ; Liao, Pu ; Han, Pu ; Zhang, Cheng ; Gao, George F. ; Huan, Yu ; Wu, Guizhen ; Li, Xiaoyan ; Xie, Yufeng ; Liu, Sheng ; Hao, Tianjiao ; Lei, Wenwen ; Liu, Peipei ; Xu, Kun ; Li, Ying ; Zhu, Baoli ; Li, Yulei ; Lu, Yafei ; Zhao, Xin ; Jin, Xiyue ; Song, Hao
Highly contagious respiratory illnesses like influenza and COVID-19 pose serious risks to public health. A two-in-one vaccine would be ideal to avoid multiple vaccinations for these diseases. Here, we generated a chimeric receptor binding domain of the spike protein (S-RBD) and hemagglutinin (HA)-stalk-based vaccine for both SARS-CoV-2 and influenza viruses. The S-RBD from SARS-CoV-2 Delta was fused to the headless HA from H1N1 (H1Delta), creating a chimera that forms trimers in solution. The cryo-electron microscopy structure of the chimeric protein complexed with the RBD-targeting CB6 and the HA-stalk-targeting CR9114 antibodies shows that the trimeric protein is stable and accessible for neutralizing antibody binding. Immunization with the vaccine elicited high and long-lasting neutralizing antibodies and effectively protected mice against the challenges of lethal H1N1 or heterosubtypic H5N8, as well as the SARS-CoV-2 Delta or Omicron BA.2 variants. Overall, this study offers a two-in-one universal vaccine design to combat infections caused by both SARS-CoV-2 variants of concern and influenza viruses.
134
项与 mRNA-1083 相关的新闻（医药）2026-04-22
iStock,
Evgenia Tsvirko
In the U.S., Moderna withdrew its approval application for the combination vaccine in May last year and the timeline for resubmission remains uncertain.
Moderna has secured the European Commission’s go-ahead for its combination flu and COVID-19 vaccine, handing the mRNA specialist a much-needed regulatory win after a rough few months of dealing with the U.S. FDA.
The shot, which will carry the brand name mCOMBRIAX, combines the
next-generation COVID-19 vaccine mNEXSPIKE
and the investigational flu vaccine mRNA-1010. The European approval covers its use across all 27 European Union member states—plus Iceland, Liechtenstein and Norway—for the active immunization of people 50 years and up, according to a Tuesday
company release
.
“We remain surprised at the willingness of the EC to grant approval,” William Blair said in a Tuesday note to investors, because mRNA-1010 has yet to be approved as a standalone shot in the EU. The Committee for Medicinal Products for Human Use gave the combo shot a
positive opinion
in February, effectively recommending approval.
Currently, MRNA-1010 is under review in the EU. “We view vaccine efficacy from mRNA-1010 as worth of approval,” the analysts continued. A Phase 3 readout in June showed that mRNA-1010 outperformed a current commercial flu shot, with a
26.6% vaccine efficacy edge
in adults aged 50 years and older.
Moderna did not provide a specific timeline for when mCOMBRIAX will be available across the EU, only noting that it will hit shelves “subject to national regulatory and access procedures.”
FDA
Moderna’s mRNA Vaccine Refusal Comes Amid Global Advanced Therapies Push
The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines. Meanwhile, streamlined communications with regulators in other countries pave the way for rapid uptake of novel modalities.
February 17, 2026
·
5 min read
·
Heather McKenzie
Read more
While Moderna has secured European approval, its combo vaccine has faced considerable struggle in the U.S. In May 2025, after discussions with the FDA, Moderna decided to
pull its approval application
for the two-in-one shot. The company did not provide specific reasoning for the withdrawal, only noting at the time that it would after receiving more data for mRNA-1010.
Despite a June 2025 readout for the flu vaccine, Moderna is still sitting on the resubmission. In January, the company
announced
that mRNA-1010 had been filed for approval but made no such disclosures for the combo shot. In a
fourth quarter earnings release
in February, Moderna said that it is “awaiting further guidance from U.S. FDA” regarding a renewed application.
That same month, mRNA-1010 also ran into a regulatory roadblock; the FDA hit Moderna with a
refusal-to-
for the flu vaccine, claiming that the company’s data package was insufficient to even warrant a review. Moderna, according to the FDA, had failed to conduct an “adequate and well-controlled” trial that compared mRNA-1010 against the “best-available standard of care.”
Analysts at the time noted that the FDA’s refusal to review mRNA-1010 could have some negative spillover to the combo shot, rendering the timeline of its resubmission uncertain. The FDA and Moderna have since come to a compromise, with the regulator
accepting
mRNA-1010 for review, setting a decision date in August.
Moderna did not make any statement on the status of the FDA application in the release announcing EU approval.
上市批准疫苗临床3期信使RNA
2026-04-21
mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized product
mCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures
CAMBRIDGE, MA /
ACCESS Newswire
/ April 21, 2026 /
Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX
®
(mRNA-1083), the Company's mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older.
This marketing authorization follows
the positive opinion
from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX is Moderna's fourth authorized product, further strengthening the Company's respiratory portfolio and commitment to the European Union.
"We welcome the European Commission's approval of mCOMBRIAX, the world's first flu plus COVID-19 combination vaccine," said Stéphane Bancel, Chief Executive Officer of Moderna. "By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk. mCOMBRIAX offers an important new option for Europeans, while also aiming to strengthen the resilience of healthcare systems across Europe."
mCOMBRIAX builds on the advances from the clinical development of
mNEXSPIKE
®
, Moderna's COVID-19 vaccine, and
mRNA-1010
, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the European Union, United States, Canada and Australia.
The EC's authorization is based on the results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier:
NCT06097273
), a randomized, observer-blind, active-controlled study evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083 in two independent age cohorts of approximately 4,000 adults each. One cohort included adults 65 years of age and older and compared mRNA-1083 to co-administered Fluzone HD
®
(licensed in the European Union as Efluelda
®
), a high-dose influenza vaccine, and Spikevax
®
, Moderna's licensed COVID-19 vaccine. The second cohort included adults 50 to 64 years of age and compared mRNA-1083 to co-administered Fluarix
®
, a standard-dose influenza vaccine, and Spikevax.
All primary endpoints demonstrating the non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 in both age cohorts. The B/Yamagata strain, which is no longer recommended for inclusion in seasonal influenza vaccines, was the only strain for which a statistically significantly higher immune response was not observed for adults 65 years of age and older compared to the co-administered licensed comparator vaccines.
[1]
mRNA-1083 demonstrated an acceptable safety and tolerability profile. The majority of solicited adverse reactions were grade 1 or 2 in severity and consistent with the licensed vaccines used in the trial.
mCOMBRIAX will be made available across the European Union, subject to national regulatory and access procedures, with Moderna working closely with national authorities to support local access and implementation.
About Moderna
Moderna is a pioneer and leader in the field of mRNA medicine. Through the advancement of its technology platform, Moderna is reimagining how medicines are made to transform how we treat and prevent diseases. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across infectious diseases, cancer, rare diseases and more.
With a global team and a unique culture, driven by the company's values and mindsets, Moderna's mission is 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, Facebook, Instagram, YouTube and LinkedIn.
mCOMBRIAX
®
, mNEXSPIKE
®
and Spikevax
®
are registered trademarks of Moderna.
Fluzone HD
®
and Efluelda
®
are registered trademarks of Sanofi Pasteur.
Fluarix
®
is a registered trademark of the GlaxoSmithKline group of companies.
Forward-Looking Statements
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 availability of mCOMBRIAX in Europe, subject to national regulatory and access procedures; Moderna's work with national authorities to support local access and implementation; the potential of combination vaccines to simplify vaccination and support improved health outcomes; ongoing regulatory review of mRNA-1010 in several jurisdictions, and the potential for approval; and the safety, reactogenicity and immunogenicity of mRNA-1083. 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. 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 "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, 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 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.
Moderna Contacts
Media:
Global:
Chris Ridley
Vice President, Global Head of Communications
+1 617-800-3651
Chris.Ridley@modernatx.com
EU:
Clothilde Caillet
Director, Country and Europe Communications Lead
(+33) 07 60 87 68 72
Clothilde.caillet@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
[1]
Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. JAMA: The Journal of the American Medical Association, published online 7 May 2025,
SOURCE
: Moderna, Inc.
View the original
press release
on ACCESS Newswire
疫苗上市批准临床结果临床3期信使RNA
2026-03-26
·雪球
一、一个90%跌幅选手的自白Moderna的股价图谱，是过去五年美股最戏剧性的叙事之一。2021年巅峰市值超2000亿美元，疫苗印钞机全速运转，华尔街的宠儿。2026年3月，市值约200亿美元，跌去了90%。曾经的mRNA革命旗手，如今被市场当作一个正在烧钱等死的biotech来定价。但事实真的是这样吗？让我们拆开看。FY2025核心数据：全年营收19亿美元（vsFY2024的32亿vsFY2023的67亿，断崖式下滑仍在继续）Q4营收6.78亿美元（在指引高端）GAAP全年净亏损28亿美元，EPS-$7.26年末现金及等价物约81亿美元（含15亿Ares信贷额度）GAAP运营费用较上年削减约22亿美元，远超削减目标2026年指引：收入增长最多10%，运营费用进一步压缩至约49亿美元数字很难看。但有两个细节值得注意：现金还很厚，以及刀砍成本的速度远超预期。二、管线：不是一个COVID公司，是一个mRNA平台公司市场给Moderna的定价，本质上是在回答一个问题：COVID疫苗之后，mRNA技术还能做什么？答案比多数人想象的丰富得多。已上市产品（3个）Spikevax/mNEXSPIKE（COVID疫苗）：仍是营收主力，但蛋糕在缩小。2025年COVID疫苗接种率继续下降，收入同比腰斩。不过COVID正在从大流行转为常规接种，类似每年打流感疫苗的逻辑。Moderna通过mNEXSPIKE（新一代COVID疫苗，获FDA批准用于65岁以上及有基础疾病人群）在差异化竞争中占据一席。mRESVIA（RSV疫苗）：2024年获批上市，目前在40个国家获批。2025年销售额仍然很小，但RSV是一个大市场——全球每年数百万老年人和婴幼儿因RSV住院。关键看2026年流感季的放量表现。在审/即将审批（2-3个）流感疫苗（mRNA-1010）：这是最近最大的戏剧性事件。2026年2月，FDA疫苗主管VinayPrasad推翻内部科学家意见，以临床试验设计不当为由拒绝受理Moderna的流感疫苗申请。一周后FDA又自己反转，同意审查，预计8月5日给出决定。这事本身说明了两个问题：(1)mRNA技术在当前美国政治环境下面临额外阻力；(2)但科学本身没有问题，产品的安全性和有效性未被质疑。欧盟、加拿大、澳大利亚已受理审查。流感+COVID联合疫苗（mRNA-1083）：欧洲药品管理局已受理，加拿大已提交。如果获批，这将是一个gamechanger——一针解决两种呼吸道疾病的年度接种需求，对老年人群极具吸引力。后期管线催化剂（2026年集中爆发）个性化癌症疫苗（intismeranautogene/mRNA-4157）：与Merck合作，目前有8个Phase2/3临床试验在不同肿瘤类型中推进（黑色素瘤、非小细胞肺癌、膀胱癌、肾细胞癌）。五年Phase2b数据显示，联合Keytruda可将黑色素瘤复发或死亡风险降低49%。Phase3黑色素瘤数据可能在2026年公布。如果数据成立，这将是mRNA技术从疫苗走向治疗的里程碑。诺如病毒疫苗（mRNA-1403）：Phase3完成入组，2026年数据读出。诺如病毒是全球急性肠胃炎的主要病因，目前没有疫苗——如果获批，又是一个从0到1的市场。丙酸血症治疗（mRNA-3927）：罕见病治疗的注册性研究已达到入组目标，2026年数据读出。这代表mRNA从预防（疫苗）到治疗（罕见病基因疗法）的跨越。三、三场战争同时打战争1：与时间赛跑的现金消耗这是Moderna最大的existentialrisk。年末现金约81亿美元，年运营费用约49亿（2026年预算），即使考虑到收入覆盖一部分，净现金消耗速度仍然惊人。管理层给出的时间表是2028年现金流收支平衡，需要收入规模达到约60亿美元。从当前19亿到60亿——这是一个3倍增长的要求，留给Moderna的时间窗口大约3年。增长路径依赖于：流感疫苗获批放量+RSV疫苗规模化+联合疫苗上市+癌症疫苗里程碑。任何一个环节失败，时间表都会被迫延长，而现金跑道并不无限。更麻烦的是，2026年7月还要支付Arbutus/Genevant专利和解的9.5亿美元首付款。如果上诉失败，总额可能高达22.5亿美元。战争2：与FDA的政治博弈RobertF.KennedyJr.担任HHS部长后，美国疫苗监管环境发生了根本性转变。FDA疫苗主管Prasad收紧审批标准，要求金标准有效性数据（实际预防疾病），而非仅靠免疫原性数据。流感疫苗的拒绝-反转闹剧就是典型案例。对Moderna来说，这意味着：美国市场的审批周期可能拉长，组合疫苗的提交策略需要重新调整，而欧洲/加拿大/澳大利亚反而可能成为更先获批的市场。战争3：与BioNTech的mRNA擂台赛Pfizer/BioNTech同样在开发mRNA流感疫苗。Arbutus的LNP专利诉讼在解决了Moderna之后，仍在起诉Pfizer/BioNTech——且2025年9月的MarkmanRuling对原告有利。这意味着BioNTech也可能面临类似的专利赔付压力。从竞争格局看，mRNA疫苗目前是Moderna和BioNTech的双寡头格局，Novavax用蛋白亚单位技术在细分市场竞争。Moderna的优势在于纯粹的mRNA平台公司，不像BioNTech还要依赖Pfizer的商业化网络。四、AI角度：Moderna是Biotech里最AI原生的公司这个角度经常被忽略，但对于长期价值非常重要。Moderna从2023年初就与OpenAI深度合作，是ChatGPTEnterprise最早一批大规模部署的企业用户。内部数据显示：超过80%的员工使用AI工具，部署了超过750个定制GPT应用，覆盖从药物研发（DoseIDGPT用于疫苗剂量优化）到法律合同审查、制造流程优化、商业化策略的全链条。CEOBancel多次公开表示，mRNA的信息化特性天然适合AI优化——mRNA序列本质上就是一段代码，可以通过计算模拟和优化来设计更好的药物。在Agent时代，这个优势可能被进一步放大。想象一个场景：AIAgent自主完成mRNA序列设计→模拟蛋白质折叠→预测免疫原性→推荐临床试验剂量→监控临床数据→生成监管提交文档。Moderna的AI基建已经为这个路径做了初始布局。当然，AI对药物研发的实际影响目前仍在早期阶段，不能过度外推。但如果mRNA+AI的飞轮真的转起来，Moderna的管线拓展速度将远超传统biotech。五、估值：市场在定价什么？当前股价约$51，市值约200亿美元。减去约81亿美元现金（扣除9.5亿专利和解后约72亿），企业价值约128亿美元。对应2026年收入指引约21亿（19亿×1.1），EV/Revenue约6倍。换一个角度：72亿现金+3个上市产品+一条价值可能巨大的癌症管线+AI原生能力=200亿市值。如果你相信癌症疫苗数据是正面的，那当前价格几乎是白送管线。如果你认为癌症疫苗会失败，那当前价格已经反映了疫苗业务的持续萎缩预期。华尔街目前共识评级Hold，目标价中位数约$44，高端$135，低端$12。分歧巨大——这本身就说明了这是一个高度依赖催化剂的事件驱动型标的。六、我的判断Moderna不是一个价值投资标的。它是一个风险投资标的——只是恰好在二级市场交易。看多的核心前提：-癌症疫苗Phase3数据积极（可能2026年H2）-流感疫苗在欧美至少一个主要市场获批-2028年现金流平衡路径可见-mRNA+AI飞轮开始产生可观测的研发效率提升看空的核心前提：-癌症疫苗数据不及预期（历史上biotech在Phase3失败率很高）-FDA政治化持续恶化，拖延多个产品审批-现金消耗速度超预期，被迫稀释性融资-COVID疫苗市场进一步萎缩，甚至接种推荐被弱化当前位置的策略思考：短期（1-3月）：LNP专利和解款7月支付，叠加FDA流感疫苗8月5日决定日——两个重大事件节点中期（6-12月）：等癌症疫苗Phase3数据，这是最大的makeorbreak催化剂仓位管理：这不是一个适合重仓的标的，波动率极高。如果参与，建议控制在组合的5%以内，并做好双向情景预案核心观察指标：癌症疫苗Phase3readout时间确认、流感疫苗FDA审批进展、季度现金消耗速度、RSV疫苗季度放量数据。一句话总结：Moderna是一个用现金买时间、用管线赌未来的公司。200亿市值买到的是一张mRNA革命的彩票——可能中大奖，也可能打水漂。免责声明：本文为个人研究笔记，不构成投资建议。Moderna的波动率可以让你一周内经历人生的大喜大悲，请量力而行。另外，mRNA技术是好的，RFKJr.的FDA是另一回事。$Moderna(MRNA)$mRNA##癌症疫苗##创新药##AI制药
疫苗信使RNA财报
100 项与 mRNA-1083 相关的药物交易
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 新型冠状病毒感染 | 欧盟 | 2026-04-21 | |
| 新型冠状病毒感染 | 冰岛 | 2026-04-21 | |
| 新型冠状病毒感染 | 列支敦士登 | 2026-04-21 | |
| 新型冠状病毒感染 | 挪威 | 2026-04-21 | |
| 流感病毒感染 | 欧盟 | 2026-04-21 | |
| 流感病毒感染 | 冰岛 | 2026-04-21 | |
| 流感病毒感染 | 列支敦士登 | 2026-04-21 | |
| 流感病毒感染 | 挪威 | 2026-04-21 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床3期 | 8,061 | Placebo+mRNA-1083 (Cohort A1: mRNA-1083 and Placebo) | 製鑰窪簾鬱選築襯鬱糧(艱觸簾選顧夢廠艱積窪) = 選糧鏇鹹夢鏇艱醖鬱範 網獵積齋蓋鬱鹹鬱壓鏇 (鹹壓窪餘衊壓壓廠鑰網, 願繭淵鏇窪壓鹽鏇獵鏇 ~ 壓憲顧鬱觸糧襯鑰夢積) 更多 | - | 2025-06-13 | ||
Influenza Vaccine (Cohort A2: Influenza Vaccine and COVID-19 Vaccine) | 製鑰窪簾鬱選築襯鬱糧(艱觸簾選顧夢廠艱積窪) = 夢顧網鏇獵顧鹹窪衊衊 網獵積齋蓋鬱鹹鬱壓鏇 (鹹壓窪餘衊壓壓廠鑰網, 鹽壓願範獵鑰蓋窪鬱糧 ~ 壓窪壓築顧糧窪遞遞簾) 更多 | ||||||
临床3期 | 8,015 | mRNA-1083+placebo (aged ≥65) | 鏇遞網夢構獵觸構齋艱(鹹廠網顧積觸製遞鬱鹹) = 廠壓顧遞構憲憲蓋夢鹽 繭鏇壓淵網範築淵蓋繭 (齋夢築鹽遞選鏇憲壓製 ) | 积极 | 2025-05-07 | ||
mRNA-1083+HD-IIV4 (aged ≥65) | 鏇遞網夢構獵觸構齋艱(鹹廠網顧積觸製遞鬱鹹) = 壓夢齋遞餘鬱範網鏇選 繭鏇壓淵網範築淵蓋繭 (齋夢築鹽遞選鏇憲壓製 ) | ||||||
临床3期 | 8,075 | 鏇網淵鏇蓋艱製醖願艱(膚壓窪襯窪願鑰憲觸齋) = from a single dose of mRNA-1083 were found to be non-inferior versus the co-administered, routinely recommended, licensed comparators. In both age cohorts, mRNA-1083 also elicited statistically significantly higher immune responses against three influenza virus strains (H1N1, H3N2, and B/Victoria) and against SARS-CoV-2. 遞夢範壓鹽醖願願獵鹽 (鏇製鹽繭鑰構繭製衊築 ) 达到 更多 | 积极 | 2024-06-10 | |||
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临床1/2期 | - | 壓壓壓衊製簾鏇窪積壓(窪齋鏇淵觸醖觸製醖築): GMT ratios = ≥1.0 更多 | 积极 | 2023-10-04 | |||
Fluarix |
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