Moderna Announces New England Journal of Medicine Publication of Pivotal Phase 3 Clinical Safety and Efficacy Data for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced a New England Journal of Medicine publication of Phase 3 P304 data for its seasonal influenza vaccine candidate mRNA-1010 on May 6, 2026. The study showed an overall relative vaccine efficacy (rVE) versus a licensed standard-dose vaccine of 26.6% (95% CI 16.7%–35.4%), with strain-specific rVEs: A/H1N1 29.6%, A/H3N2 22.2%, and B/Victoria 29.1%.

Subgroup analyses were consistent across ages and risk factors; in participants aged 65+, rVE was 27.4%. Regulatory reviews are underway in the U.S., Europe, Canada and Australia, with a U.S. PDUFA goal date of August 5, 2026.

Positive

• Peer-reviewed Phase 3 results published in New England Journal of Medicine
• Overall rVE of 26.6% (95% CI 16.7%–35.4%) versus standard-dose vaccine
• Strain-specific rVEs: A/H1N1 29.6%, A/H3N2 22.2%, B/Victoria 29.1%
• Consistent rVE point estimates across age groups and risk-factor subgroups
• Regulatory submissions accepted in U.S., Europe, Canada, Australia with PDUFA date Aug 5, 2026

Negative

• Overall rVE reported as 26.6%, a relative measure rather than absolute vaccine efficacy
• Approvals remain pending; regulatory reviews in multiple jurisdictions are ongoing
• No absolute attack-rate or absolute risk reduction figures disclosed in the announcement

News Market Reaction – MRNA

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In the May 7 session, MRNA declined 0.51%, reflecting a mild negative market reaction. Argus tracked a peak move of +7.8% during that session. Our momentum scanner triggered 68 alerts that day, indicating high trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement highlights peer‑reviewed Phase 3 data for mRNA‑1010, with overall rVE of 26.6% and...

Analysis

This announcement highlights peer‑reviewed Phase 3 data for mRNA‑1010, with overall rVE of 26.6% and consistent efficacy across key strains and in adults 65+. It follows a series of clinical milestones in flu and oncology, while regulatory review is underway with a PDUFA goal date of August 5, 2026. Investors may monitor future updates on regulatory decisions, commercial planning for seasonal flu, and how these programs contribute alongside broader pipeline progress.

Key Figures

Overall rVE: 26.6% 95% CI for rVE: 16.7% to 35.4% A/H1N1 rVE: 29.6% +5 more

8 metrics

Overall rVE 26.6% Phase 3 P304, mRNA-1010 vs standard-dose flu vaccine

95% CI for rVE 16.7% to 35.4% Confidence interval for overall relative vaccine efficacy

A/H1N1 rVE 29.6% Strain-specific relative vaccine efficacy in Phase 3 P304

A/H3N2 rVE 22.2% Strain-specific relative vaccine efficacy in Phase 3 P304

B/Victoria rVE 29.1% Strain-specific relative vaccine efficacy in Phase 3 P304

rVE age 65+ 27.4% Participants aged 65 years and older in Phase 3 P304

Flu hospitalizations 545,000 Americans Seasonal flu-related hospitalizations in 2024–2025 per CDC

PDUFA goal date August 5, 2026 FDA PDUFA goal date for mRNA-1010

Previous Clinical trial Reports

5 past events · Latest: Apr 21 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 21	Flu Phase 3 start	Positive	+0.9%	Initiation of Phase 3 H5 pandemic influenza vaccine study mRNA-1018.
Apr 17	Oncology Phase 1/2 data	Positive	-1.8%	Phase 1/2 melanoma data for mRNA-4359 plus pembrolizumab with high ORR.
Jan 20	Melanoma 5-year data	Positive	+2.8%	Five-year KEYNOTE-942 data showing 49% reduced recurrence or death risk.
Dec 18	Flu trial funding	Positive	+1.4%	CEPI funding up to $54.3M for pivotal Phase 3 H5 flu trial mRNA-1018.
Nov 03	Myeloma trial start	Positive	-8.3%	First patient dosed in Phase 1/2 study of T-cell engager mRNA-2808.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Across recent 5 clinical‑trial headlines, reactions were mixed: 3 aligned with generally positive data and 2 diverged, including one sizeable selloff.

Recent Company History

Recent clinical‑trial news for Moderna spans oncology and infectious disease. On Apr 21, 2026, the H5 pandemic flu Phase 3 initiation (mRNA‑1018) saw a modest +0.93% move. Earlier, strong KEYNOTE‑942 five‑year melanoma data on Jan 20, 2026 coincided with a +2.8% reaction, while other positive updates, such as mRNA‑4359 melanoma data and the mRNA‑2808 multiple myeloma study start, saw negative moves. Today’s mRNA‑1010 Phase 3 publication fits this pattern of major clinical updates across vaccines and oncology.

Key Terms

relative vaccine efficacy, a/h1n1, a/h3n2, pdufa, +1 more

5 terms

relative vaccine efficacy medical

"evaluating the relative vaccine efficacy (rVE) of mRNA-1010 against influenza illness"

Relative vaccine efficacy measures how much better one vaccine prevents illness compared with another vaccine or a different standard, expressed as a percentage change in risk. Think of it like comparing two umbrellas by how much more rain one keeps off you than the other; investors watch this metric because higher relative efficacy can drive stronger demand, pricing power, regulatory favor and longer-term revenue, while lower efficacy can hurt market share and valuation.

a/h1n1 medical

"including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages"

A/H1N1 is a specific subtype of the influenza A virus that can cause contagious respiratory illness in people and animals, ranging from routine seasonal flu to larger outbreaks. For investors it matters because shifts in infection rates influence demand for vaccines, treatments, testing, and can disrupt travel, retail, and workplaces—much like a widely spreading cold that temporarily shuts down parts of the economy and changes short-term earnings and supply chains.

a/h3n2 medical

"including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages"

A/H3N2 is a specific strain of the influenza A virus that causes seasonal flu in humans; think of it like a particular model of a car within a larger brand of viruses. It matters to investors because shifts in how common or severe A/H3N2 is can change demand for vaccines, antiviral medicines, hospital services and worker productivity, and can therefore affect revenue and stock prices across healthcare, pharmaceutical, and related sectors.

pdufa regulatory

"has received a U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date"

PDUFA is the Prescription Drug User Fee Act, the U.S. law under which drug companies pay fees that fund the FDA's review of new medicines. In company news the term usually appears as the PDUFA date, the target deadline by which the FDA aims to decide on a drug application; that date tells investors when to expect the approval or rejection decision for the product.

mRNA medical

"our mRNA-based seasonal flu vaccine has the potential to more precisely match circulating strains"

mRNA, short for messenger ribonucleic acid, is a biological molecule that carries instructions from a cell’s genetic blueprint to make specific proteins — like a recipe or software code that tells a kitchen or computer what to produce. Investors care because mRNA is used as a flexible drug and vaccine platform that can be developed and scaled faster than many traditional medicines; its commercial prospects, manufacturing needs, regulatory approval path, and patent position can strongly affect a company’s value.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Regulatory filings are under review in the U.S., Europe, Canada and Australia, with potential approvals expected to begin in 2026

CAMBRIDGE, MA / ACCESS Newswire / May 6, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced a publication in the New England Journal of Medicine of the positive Phase 3 study results evaluating mRNA-1010, its vaccine candidate for seasonal influenza. The peer-reviewed article summarizes the safety and efficacy data from Moderna's Phase 3 study (P304) evaluating the relative vaccine efficacy (rVE) of mRNA-1010 against influenza illness compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older.

As previously reported, mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population. Additionally, strong rVE was observed for each influenza strain contained in the vaccine, including A/H1N1 (rVE=29.6%), A/H3N2 (rVE=22.2%), and the B/Victoria lineages (rVE=29.1%). 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%.

"The publication of these peer-reviewed positive results in the New England Journal of Medicine reflects the strength of the clinical evidence supporting our ongoing regulatory submissions," said Stéphane Bancel, Chief Executive Officer of Moderna. "In addition to demonstrating superior relative vaccine efficacy compared to a standard-dose flu vaccine, our mRNA-based seasonal flu vaccine has the potential to more precisely match circulating strains and help reduce the substantial burden of disease caused by influenza in older adults."

According to the U.S. Centers for Disease Control (CDC), seasonal flu-related hospitalizations and outpatient visits reached a 15-year high during the 2024-2025 season. More than 545,000 Americans were hospitalized due to flu-related illness last year, leading to substantial direct and indirect costs, as well as widespread disruption to daily life and work.^[1]

mRNA-1010 has been accepted for regulatory review in the U.S., Europe, Canada and Australia. Moderna has received a U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. Regulatory submissions in additional countries are planned for 2026.

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 filings for mRNA-1010 and ongoing regulatory review; the potential for approvals of mRNA-1010 to begin in 2026; the safety and efficacy of mRNA-1010; the potential of mRNA-1010 to more precisely match circulating strains; Moderna's PDUFA goal date; and regulatory submissions for mRNA-1010 planned for additional countries in 2026. 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 www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

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

[1] https://www.cdc.gov/flu/whats-new/2025-2026-influenza-activity.html

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Moderna (MRNA) announce about mRNA-1010 Phase 3 results on May 6, 2026?

Moderna announced publication of Phase 3 P304 data showing an overall rVE of 26.6% versus a standard-dose flu vaccine. According to Moderna, strain-specific rVEs included 29.6% A/H1N1, 22.2% A/H3N2, and 29.1% B/Victoria.

What is the U.S. regulatory timeline for Moderna's (MRNA) mRNA-1010 vaccine?

Moderna has a U.S. FDA PDUFA goal date of August 5, 2026 for mRNA-1010. According to Moderna, regulatory submissions are also under review in Europe, Canada and Australia, with additional filings planned for 2026.

How effective was mRNA-1010 in adults aged 65 and older in the Phase 3 trial?

In participants aged 65 and older, mRNA-1010 showed an rVE of 27.4% versus a standard-dose vaccine. According to Moderna, subgroup analyses showed consistent rVE point estimates across age groups and risk factors.

Does the Phase 3 release for mRNA-1010 include absolute efficacy or attack-rate numbers?

The announcement reports relative vaccine efficacy percentages but does not provide absolute vaccine efficacy or attack-rate figures. According to Moderna, the published paper focuses on rVE and strain-specific relative results.

What strains did Moderna (MRNA) report as covered by mRNA-1010 in the Phase 3 results?

Moderna reported strong relative efficacy against included strains: A/H1N1 (29.6%), A/H3N2 (22.2%), and B/Victoria (29.1%). According to Moderna, mRNA-1010 demonstrated consistent performance across each strain in the study.