A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.

Start Date16 Sep 2024

Sponsor / Collaborator

ModernaTX, Inc.

NCT05868382

/ CompletedPhase 2

A Phase 2, Randomized, Active-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults 18 to 49 Years of Age

The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.

Start Date15 May 2023

Sponsor / Collaborator

ModernaTX, Inc.

NCT05827978

/ CompletedPhase 3

A Phase 3, Randomized, Stratified, Observer-Blind, Active-Controlled Study to Evaluate the Immunogenicity, Reactogenicity and Safety of mRNA-1010 Seasonal Influenza Vaccine in Adults 18 Years and Older

This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.

Start Date17 Apr 2023

Sponsor / Collaborator

ModernaTX, Inc.

100 Clinical Results associated with mRNA-1010

100 Translational Medicine associated with mRNA-1010

100 Patents (Medical) associated with mRNA-1010

Literatures (Medical) associated with mRNA-1010

31 Dec 2025·Human Vaccines & Immunotherapeutics

An mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers

Article

Author: Hall, Kristi ; Avanesov, Andrei ; Huang, Wenmei ; Llapur, Conrado ; Kandinov, Boris ; Zheng, Lingyi ; Fierro, Carlos ; Du, Evelyn ; Park, Yoonyoung ; Nachbagauer, Raffael ; Rudden, Sinead ; Miller, Jacqueline ; Ananworanich, Jintanat ; Ma, Chong ; Hicks, Bryony ; Schaefers, Kristin ; Soens, Mieke ; Guo, Jia ; Essink, Brandon ; Vakil, Jignesh ; Ensz, David ; Pucci, Alicia ; Zhou, Honghong

The safety, immunogenicity, and efficacy of the original formulation of the investigational mRNA-1010 vaccine for seasonal influenza were investigated in two randomized, active-controlled, phase 3 trials in adults (NCT05415462 and NCT05566639), and the results were used to evaluate hemagglutination inhibition (HAI) titers as correlates of risk and protection against influenza-like illness. mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials. The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains and lower responses against influenza B strains relative to an active comparator (licensed inactivated influenza vaccine). An analysis of HAI titers as a correlate of protection against influenza infection provided support for its use as a surrogate endpoint for mRNA-1010, similar to licensed influenza vaccines. These findings support further optimization and development of mRNA-1010 against seasonal influenza.

01 Mar 2025·VACCINE

A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults

Article

Author: Miller, Jacqueline ; Du, Evelyn ; Nachbagauer, Raffael ; Schaefers, Kristi ; Chen, Ren ; Lucas, Kathryn Jean ; Hicks, Bryony ; Soens, Mieke ; Cardona, Jose ; Livermore, Greg ; Ananworanich, Jintanat ; Choi, Angela ; Das, Rituparna ; Avanesov, Andrei ; Henry, Carole ; Pucci, Alicia ; Sher, Lawrence

BACKGROUND:

Messenger RNA (mRNA)-based influenza vaccines have the potential to improve upon limitations of current vaccine approaches to seasonal influenza.

METHODS:

Here we report findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of the quadrivalent mRNA vaccine, mRNA-1010, versus licensed standard-dose and high-dose quadrivalent influenza vaccines from a three-part, phase 3 clinical trial in adults aged ≥18 years (Part A), 18-64 years (Part B), and ≥ 65 years (Part C) (NCT05827978).

RESULTS:

A single 50-μg dose of mRNA-1010 elicited hemagglutination inhibition titers against vaccine-matched strains that were statistically noninferior and superior to licensed standard-dose and high-dose egg-based quadrivalent vaccine comparators. Solicited adverse reactions were more frequent with receipt of mRNA-1010; adverse reactions were lower in frequency and severity among adults aged ≥65 years than younger adults. No safety concerns were identified.

CONCLUSIONS:

These findings support the potential benefit of mRNA-1010 as a seasonal influenza vaccine.

04 Feb 2025·JOURNAL OF INFECTIOUS DISEASES

Safety and Immunogenicity of mRNA-1010, an Investigational Seasonal Influenza Vaccine, in Healthy Adults: Final Results From a Phase 1/2 Randomized Trial

Article

Author: Lee, Ivan T ; Henry, Carole ; Nachbagauer, Raffael ; McGrath, Shannon ; Choi, Angela ; Kuo, Hsiao-Hsuan ; Chen, Ren ; Paris, Robert ; Huang, Wenmei ; Stadlbauer, Daniel ; Ensz, David ; Avanesov, Andrei ; Pucci, Alicia ; Schaefers, Kristi ; Ananworanich, Jintanat ; Carmona, Lizbeth

Abstract:

Background:

Seasonal influenza remains a global public health concern. A messenger RNA (mRNA)–based quadrivalent seasonal influenza vaccine, mRNA-1010, was investigated in a first-in-human, phase 1/2 clinical trial conducted in 3 parts.

Methods:

In parts 1 to 3 of this stratified observer-blind study, adults aged ≥18 years were randomly assigned to receive a single dose (6.25–200 µg) of mRNA-1010 or placebo (part 1) or an active comparator (Afluria; parts 2 and 3). Primary study objectives were assessment of safety, reactogenicity, and humoral immunogenicity of mRNA-1010, placebo (part 1), or active comparator (parts 2 and 3). Exploratory end points included assessment of cellular immunogenicity (part 1) and antigenic breadth against vaccine heterologous strains (A/H3N2; parts 1 and 2).

Results:

In all study parts, solicited adverse reactions were reported more frequently for mRNA-1010 than placebo or Afluria, and most were grade 1 or 2 in severity. No vaccine-related serious adverse events or deaths were reported. In parts 1 and 2, a single dose of mRNA-1010 (25–200 µg) elicited robust day 29 hemagglutination inhibition titers that persisted through 6 months. In part 3, lower doses of mRNA-1010 (6.25–25 µg) elicited day 29 hemagglutination inhibition titers that were higher or comparable to those of Afluria for influenza A strains. When compared with Afluria, mRNA-1010 (50 µg) elicited broader A/H3N2 antibody responses (part 2). mRNA-1010 induced greater T-cell responses than placebo at day 8 that were sustained or stronger at day 29 (part 1).

Conclusions:

Data support the continued development of mRNA-1010 as a seasonal influenza vaccine.

Clinical Trials Registration:

NCT04956575 (https://clinicaltrials.gov/study/NCT04956575).

108

News (Medical) associated with mRNA-1010

05 Jan 2026

·firstwordpharma.com

Biopharma bites: Aktis' IPO, argenx CEO swap and Moderna's mRNA flu play

Radiopharma IPOAktis is preparing to test the public markets with a proposed public offering that could raise over $200 million, joining a short list of companies attempting an IPO amid a prolonged sector downturn.In a US securities filing Monday, the Boston-based radiopharmaceutical developer said it plans to sell roughly 11.8 million shares at a range of $16 to $18 per share. At the midpoint, the company would raise $200.2 million and boast a fully diluted market cap of $860 million.The bulk of the capital will go toward expanding two programmes: approximately $140 million to $150 million to continue the ongoing Phase Ib trial of its lead candidate [225Ac]Ac-AKY-1189 for Nectin-4–expressing tumours, and $70 million to $80 million to advance [225Ac]Ac-AKY-2519 into a Phase Ib study for B7-H3–positive tumours.Aktis ended September with $246.2 million in cash, cash equivalents and marketable securities and expects its combined resources and IPO proceeds to fund operations into the first half of 2028.The company has raised at least $336 million privately, including an oversubscribed $175-million series B in 2024 and an $84-million series A extension in 2022, with backing from Novartis, Bristol Myers Squibb, Eli Lilly and Merck & Co.New CEO at argenxFollowing the first approvals and launches of argenx's flagship autoimmune drug, co-founder Tim Van Hauwermeiren is stepping down as CEO, handing the leadership baton to Chief Operating Officer (COO) Karen Massey.The company first secured FDA approval for intravenous Vyvgart in late 2021 for generalised myasthenia gravis (gMG), followed by approvals for the FcRn inhibitor's subcutaneous counterpart, Vyvgart Hytrulo, for gMG in 2023 and chronic inflammatory demyelinating polyneuropathy a year after that.However, hopes of securing another indication for its sole marketed drug were dashed last month after the company said it would discontinue Phase III studies in thyroid eye disease due to futility."Karen has delivered exceptional impact since joining argenx three years ago — accelerating Vyvgart's launch [and] building a future-proof commercial engine," said Van Hauwermeiren, who will transition to non-executive director and chairman of the board. "As chairman, I will be a sounding board to Karen and the team on long-term strategy, stay close to the innovation mission by engaging with the external ecosystem and lead the board's evolution to facilitate our next phase of growth."Massey joined argenx as COO in early 2023 after nearly a decade at Genentech, where she served as senior vice president of product development and global clinical operations. She started her biopharmaceutical career in marketing at Pfizer.Moderna's mRNA flu shotRiding the rollercoaster of COVID-19 vaccine triumphs and the lows of a post-pandemic sales slump, Moderna said Monday that the company is moving on to its next infectious disease goal and submitted filings for its experimental mRNA-1010 seasonal flu vaccine to regulators in the US, EU, Canada and Australia."The issue of vaccine mismatch due to virus mutations has long worried influenza experts and, as we have seen this flu season, can lead to a heightened public health burden," CEO Stéphane Bancel said. "The agility and flexibility of mRNA technology offer the potential to more closely match evolving strains and more effectively respond to one of the world's most persistent respiratory threats."The applications follow positive Phase III results in adults aged 50 and older. Compared to a licensed standard-dose seasonal influenza jab, mRNA-1010 achieved a relative vaccine efficacy against influenza illness of 26.6% in the P304 trial, rising to 27.4% in those aged 65 years and older.The company last year withdrew its FDA application for mRNA-1083, a combination influenza/COVID-19 candidate, after regulators requested additional Phase III flu efficacy data.More recently, Moderna was the recipient of a $54.3-million award from the Coalition for Epidemic Preparedness Innovations, which is funding late-stage development of the company's H5 avian influenza vaccine, mRNA-1018.

Phase 3VaccineDrug ApprovalExecutive ChangeClinical Result

05 Jan 2026

·www.biopharmadive.com

Moderna, searching for a rebound, to seek approval of mRNA flu shot

Moderna has filed approval applications for a seasonal flu vaccine it expects to become a critical source of future revenue growth.The company on Monday said it submitted clearance requestswith regulators in the U.S., Europe, Canada and Australia. Moderna is specifically seeking approvals to market the vaccine, dubbed mRNA-1010, for people at least 50 years of age.If approved, this potential new product launch and geographic expansion represent an important opportunity to support Modernas continued growth in 2027 and beyond, said Moderna CEO Stphane Bancel, in a statement.Modernas vaccine is built on the same messenger RNA technology its used to bring shots to market for COVID-19 and respiratory syncytial virus. That technology enables it to design and create shots more quickly than with established technologies. Such an advantage could help Moderna more closely match evolving strains of flu and more effectively respond to the virus, Bancel noted.In clinical testing in people 50 years of age or older, mRNA-101 reduced the risk of influenza illness by 27% compared to marketed shots targeting three or four strains of the virus.The shot was similarly effective among study participants at least 65 years old, who are at a higher risk of poor health outcomes from the flu. Side effects were also mostly mild and not significantly different from what was observed in people who got another vaccine.For Moderna, those results were a critical part of its plans to rebound from a series of setbacks that have significantly depressed its stock price. Flagging COVID vaccine sales, minimal contributions from its RSV shot and heightened scrutiny of mRNA technology in the U.S.have eroded the companys market value, leading to layoffs, missed revenue projections and a strategic restructuring. Moderna also saw a shot for cytomegalovirus once projected to be a future blockbuster fail a Phase 3 trial in October.Still, the company hopes to break even financially in 2028 and the flu vaccine as well as a combination COVID-19 and flu shot are seen as revenue drivers that will help. Moderna had previously filed for approval of the combination shot, but decided to pull the applicationamid heightened regulatory standardsand instead wait for new results from its standalone flu vaccine.Moderna intends to invest the cash from its respiratory disease franchise, which includes those vaccines, into its oncology and rare disease programs. A skin cancer vaccine its working on with Merck & Co. could produce study results this year. '

VaccinemRNAPhase 3Drug ApprovalClinical Result

05 Jan 2026

·www.biospace.com

Moderna Announces Global Regulatory Submissions for Its Investigational Seasonal Influenza Vaccine

Moderna has filed for marketing authorization in the U.S., EU, Canada and Australia for mRNA-1010 CAMBRIDGE, MA / ACCESS Newswire / January 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults aged 50 years and older. The Company has filed for marketing authorization with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and the Therapeutic Goods Administration (TGA) in Australia. "We are proud to announce these filings for the use of our seasonal flu vaccine candidate, a major milestone for our respiratory portfolio," said Stéphane Bancel, Chief Executive Officer of Moderna. "The issue of vaccine mismatch due to virus mutations has long worried influenza experts and, as we have seen this flu season, can lead to a heightened public health burden. The agility and flexibility of mRNA technology offer the potential to more closely match evolving strains and more effectively respond to one of the world's most persistent respiratory threats. If approved, this potential new product launch and geographic expansion represent an important opportunity to support Moderna's continued growth in 2027 and beyond." The regulatory applications are based on positive data from multiple Phase 3 studies. In a Phase 3 efficacy study (P304), mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with a relative vaccine efficacy (rVE) of 26.6% (95% CI; 16.7%, 35.4%) across all adults aged 50 years and older. Subgroup analyses confirmed a consistently strong rVE point estimate across age groups, risk factors and previous influenza vaccination status. In participants aged 65 years and older, mRNA-1010 demonstrated an rVE of 27.4%. In a previous Phase 3 study (P303), mRNA-1010 had demonstrated superior seroconversion rates and geometric mean titer ratios (GMR) against all strains included in the vaccine compared to both high-dose and standard-dose licensed seasonal influenza vaccine. mRNA-1010 has been found to be well tolerated with a favorable safety profile. The majority of solicited adverse reactions (SARs) have been mild. Injection site pain was the most common local SAR, and fatigue, headache and myalgia were the most common systemic SARs reported. 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. 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: Moderna's regulatory submissions; mRNA-1010's efficacy and safety; and the ability of mRNA technology to more closely match evolving strains and more effectively respond to respiratory threats. 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, 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 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: Chris Ridley Head of Global Media Relations +1 617-800-3651 Chris.Ridley@modernatx.com Investors: Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 Lavina.Talukdar@modernatx.com SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire

Phase 3VaccineClinical ResultmRNADrug Approval

100 Deals associated with mRNA-1010

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	NDA/BLA	United States	Moderna, Inc.	05 Jan 2026
Influenza, Human	NDA/BLA	European Union	Moderna, Inc.	05 Jan 2026
Influenza, Human	NDA/BLA	Australia	Moderna, Inc.	05 Jan 2026
Influenza, Human	NDA/BLA	Canada	Moderna, Inc.	05 Jan 2026

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06602024 (Company_Website \| Corporate Publications) Manual	Phase 2/3	Influenza, Human	40,703	mRNA-1010	sudbgtaaxp(wgainqqctz) = mrutfgybbt pwcutgibny (pfsfhanzjw, 16.7 - 35.4) Met View more	Positive	19 Oct 2025
				Licensed SD Influenza Vaccine	unrakalfnz(wwtuuxscyi) = qdvvsqbowt zrpswdsecr (pbtapvikjq ) View more
NCT05827978 (IGNITE P303, CTgov)	Phase 3	Influenza, Human	8,411	Fluarix QIV (Part A: Fluarix QIV)	xyuhqgjxxx(lrpzivysor) = hxbyvqgixa tlwdzupaoz (qfhnamdrxy, nwalxgheza - qjfdqsatol) View more	-	10 Jul 2025
				mRNA-1010 (Part A: mRNA-1010)	xyuhqgjxxx(lrpzivysor) = ztjvpzhgyh tlwdzupaoz (qfhnamdrxy, pxsxliwxxw - dotvmtbskl) View more
NCT05566639 (CTgov)	Phase 3	Influenza, Human	22,502	Fluarix Quadrivalent (Fluarix Quadrivalent)	vhmbthfxam = cnjjewsgjd mcsgidubra (tmilpdmemo, zqglkjdkyd - jwnzztvurw) View more	-	16 Jan 2025
				mRNA-1010 (mRNA-1010)	vhmbthfxam = rpyitzcahz mcsgidubra (tmilpdmemo, jywfvqtzuf - eeiinrkbck) View more
NCT05868382 (CTgov)	Phase 2	Influenza, Human	270	mRNA-1010 (mRNA-1010)	bvebtmbtjd = vqkzmeciwc gjhwcpcdqe (walfuhgtkt, xnlokamgnv - skaggsmeie) View more	-	20 Dec 2024
				mRNA-1010.4 (mRNA-1010.4 Low Dose)	bvebtmbtjd = bxkkzbkhvm gjhwcpcdqe (walfuhgtkt, kluksfoqsd - tovryhnpoe) View more
NCT05415462 (CTgov)	Phase 3	Influenza, Human	6,102	Fluarix Tetra (Fluarix Tetra)	alrmezyqgn(zdcqqbdgwx) = vetcdscpqr vivyxpezpm (yxhwqdkdym, sstipgdehf - dlhxlaqwhx) View more	-	24 Sep 2024
				mRNA-1010 (mRNA-1010)	alrmezyqgn(zdcqqbdgwx) = ojuugxkqeu vivyxpezpm (yxhwqdkdym, fzyllqzhpf - lkwukefrqk) View more
NCT04956575 (Pubmed) Manual	Phase 1/2	Influenza, Human	-	mRNA-1010	pazuhlnixx(rtmzexhdrq) = reported more frequently for mRNA-1010 than placebo or Afluria and most were grade 1 or 2 in severity. utuwrlfmum (ziyszyruon ) View more	Positive	27 Jun 2024
				Placebo
NCT05375838 (CTgov)	Phase 1/2	COVID-19 \| Influenza, Human	550	placebo+mRNA-1273 (mRNA-1273 + Placebo)	gordrvqsrr = qupdcfvwkz uacrvuukdl (kqjzlwrbks, waddcuoqoo - elkciqucaz) View more	-	28 Feb 2024
				placebo+mRNA-1010 (mRNA-1010 + Placebo)	gordrvqsrr = shmojjmbzf uacrvuukdl (kqjzlwrbks, hydshletcb - pcvnviinuk) View more
NCT05415462 (Company_Website) Manual	Phase 3	Influenza, Human	-	mRNA-1010	zlgcnefvnr(flrkazrtff) = qcyfazjnsg saimppclje (fenivkskna )	Non-inferior	16 Feb 2023
				Fluarix Tetra	zlgcnefvnr(flrkazrtff) = ozmhzbzjof saimppclje (fenivkskna )

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