European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19

Rhea-AI Summary

Moderna (NASDAQ:MRNA) announced the EMA CHMP adopted a positive opinion recommending EU marketing authorization for mCOMBRIAX (mRNA-1083), a first-in-class influenza plus COVID-19 combination vaccine for adults 50 years and older. The opinion is supported by a pivotal Phase 3 trial and an acceptable safety profile.

Final authorization depends on a European Commission decision and national regulatory/access processes; if approved, this would be Moderna's fourth marketed product in Europe.

Positive

• CHMP issued a positive opinion recommending EU authorization
• Pivotal Phase 3 enrolled ~4,000 adults per age cohort
• mRNA-1083 showed higher immune responses vs comparators for 3 influenza strains and SARS-CoV-2
• Acceptable safety and tolerability; most adverse reactions grade 1–2

Negative

• No statistically higher response for B/Yamagata in adults 65+
• Marketing authorization still subject to European Commission decision
• Indication limited to adults aged 50 years and older

Key Figures

Age indication: 50 years and older Age cohort 1: 65 years and older Age cohort 2: 50 to 64 years +3 more

6 metrics

Age indication 50 years and older Indicated population for mCOMBRIAX in EU CHMP opinion

Age cohort 1 65 years and older Older adult cohort in Phase 3 trial

Age cohort 2 50 to 64 years Younger adult cohort in Phase 3 trial

Cohort size approximately 4,000 adults Each of two Phase 3 age cohorts

Influenza strains 3 strains A/H1N1, A/H3N2 and B/Victoria with higher immune responses

Trial phase Phase 3 Pivotal mRNA-1083 study for CHMP opinion

Market Reality Check

Price: $51.71 Vol: Volume 5,746,079 is below...

low vol

$51.71 Last Close

Volume Volume 5,746,079 is below the 20-day average of 10,458,365, suggesting a moderate pre-news positioning. low

Technical Shares at $51.71 are trading above the 200-day MA of $30.28 and 6.32% below the 52-week high of $55.20.

Peers on Argus

While MRNA was modestly higher pre-announcement, key biotech peers showed mixed ...

1 Up

While MRNA was modestly higher pre-announcement, key biotech peers showed mixed moves (e.g., ROIV and HALO down, MDGL slightly up), and the momentum scanner flagged only ABVX up with no news, indicating a stock-specific setup rather than a broad sector move.

Previous Covid-19 Reports

5 past events · Latest: Feb 17 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 17	EU COVID approval	Positive	+4.0%	EC marketing authorization for mNEXSPIKE across EU and EEA markets.
Dec 15	CHMP positive opinion	Positive	+1.6%	EMA CHMP positive opinion recommending EU authorization of mNEXSPIKE.
Sep 16	Variant update data	Positive	+4.0%	Positive Phase 4 data for Spikevax targeting LP.8.1 variant with strong responses.
Aug 22	Health Canada approval	Positive	+3.4%	Health Canada approval for updated Spikevax targeting LP.8.1 variant.
Jul 30	EU COVID approval	Positive	-8.1%	European Commission approval for updated Spikevax against LP.8.1 variant.

Pattern Detected

COVID-19 and CHMP/approval headlines for Moderna have usually led to positive price reactions, with one notable negative outlier on an EU approval.

Recent Company History

Over the past year, Moderna’s covid-19-tagged news has centered on updated Spikevax formulations, regional approvals, and EU regulatory milestones. Positive CHMP opinions and European Commission or Health Canada approvals for mNEXSPIKE and updated Spikevax have generally coincided with gains between about 1% and 4%, except for one -8.06% reaction to an EU approval. Today’s CHMP opinion for mCOMBRIAX fits this pattern of incremental, regulator-driven expansion of Moderna’s respiratory vaccine franchise in major markets.

Historical Comparison

+1.0% avg move · In the last five covid-19 updates, MRNA moved about 1% on average. Today’s CHMP opinion for the flu+...

covid-19

+1.0%

Average Historical Move covid-19

In the last five covid-19 updates, MRNA moved about 1% on average. Today’s CHMP opinion for the flu+COVID combo vaccine fits within that historically moderate reaction range.

Historically, Moderna’s covid-19 news moved from variant-specific Spikevax updates to regional approvals and CHMP opinions. Today’s mCOMBRIAX decision extends that path into combination flu+COVID vaccination in Europe.

Market Pulse Summary

This announcement details a positive CHMP opinion for mCOMBRIAX, a flu plus COVID-19 combination vac...

Analysis

This announcement details a positive CHMP opinion for mCOMBRIAX, a flu plus COVID-19 combination vaccine for adults 50+, supported by a pivotal Phase 3 trial of roughly 4,000 participants per age cohort. All primary non-inferiority endpoints were met with acceptable safety. In context of prior EU approvals for mNEXSPIKE and updated Spikevax, investors may watch for final European Commission authorization and national access decisions to gauge the commercial impact within Moderna’s respiratory vaccine portfolio.

Key Terms

committee for medicinal products for human use, marketing authorization, mRNA, phase 3, +4 more

8 terms

committee for medicinal products for human use regulatory

"European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion"

The Committee for Medicinal Products for Human Use is the expert scientific panel within the European medicines regulator that assesses whether medicines for people are safe, effective and of acceptable quality, and issues formal opinions used in the drug-approval process. Its assessments act like a gatekeeper or safety inspector for entering the European market, so the committee’s opinion can materially affect a drug’s commercial prospects, regulatory risk and a company’s stock valuation.

marketing authorization regulatory

"positive opinion recommending marketing authorization in the European Union for mCOMBRIAX"

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

mRNA medical

"mCOMBRIAXae (mRNA-1083), Moderna's combination vaccine indicated for active immunization"

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.

phase 3 medical

"results from the pivotal Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06097273)"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized medical

"a randomized, observer-blind, active-controlled study evaluating the safety"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

observer-blind medical

"a randomized, observer-blind, active-controlled study evaluating the safety"

Observer-blind describes a study setup where the people who evaluate results do not know which treatment each participant received, even if others involved might know. For investors, this matters because it reduces the chance that personal expectations or knowledge will skew measurements of effectiveness or safety, making reported outcomes more reliable—similar to a referee judging a game without knowing which team used a new piece of equipment.

active-controlled medical

"a randomized, observer-blind, active-controlled study evaluating the safety"

An active-controlled study is a trial in which the new treatment is compared against an existing, approved treatment instead of a placebo. For investors, this matters because results show how the new product stacks up against the current standard—like testing a new phone by comparing it to a popular model rather than to no phone—so positive results can indicate real competitive advantage and clearer market value.

sars-cov-2 medical

"for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals"

SARS-CoV-2 is the virus that causes the illness known as COVID-19; think of it as a biological engine that can start chains of sickness in people. It matters to investors because its spread and the measures taken to control it—such as changes to workforce availability, consumer demand, supply chains, travel, and healthcare spending—can quickly alter company revenues, costs and regulatory priorities, much like a sudden storm that affects many parts of an economy at once.

AI-generated analysis. Not financial advice.

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion

mCOMBRIAX will be made available in the European Union, subject to final European Commission authorization and national regulatory and access procedures

CAMBRIDGE, MASSACHUSETTS / ACCESS Newswire / February 27, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization in the European Union for mCOMBRIAX^® (mRNA-1083), Moderna's combination vaccine indicated for active immunization for the prevention of influenza and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older.

"The CHMP's positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world's first flu plus COVID combination vaccine. If approved, this would be Moderna's fourth marketed product in Europe," said Stéphane Bancel, Chief Executive Officer of Moderna. "Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA's rigorous scientific review."

mCOMBRIAX builds on the advances of mNEXSPIKE^®, Moderna's COVID-19 vaccine, and mRNA-1010, Moderna's investigational seasonal influenza vaccine, which has been accepted for review in the United States, the European Union, Canada and Australia.

The CHMP opinion is supported by 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.

Following the CHMP's positive opinion, the European Commission will consider the recommendation and is expected to adopt a final decision on marketing authorization. Once the European Commission approves a product, the marketing authorization is valid in all EU Member States as well as in the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway. Upon European Commission approval, Moderna will work with national regulatory and health 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; the potential of combination vaccines to simplify vaccination and support improved health outcomes; potential approvals of mRNA-1010 in markets worldwide; the immunogenicity and safety profile of mCOMBRIAX; the European Commission's anticipated marketing authorization of mCOMBRIAX; and local access and implementation upon approval. 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
Vice President, Global Head of Communications
+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]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, https://jamanetwork.com/journals/jama/fullarticle/2833668

SOURCE: Moderna, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Moderna (MRNA) announce on February 27, 2026 about mCOMBRIAX?

Moderna announced the EMA CHMP adopted a positive opinion recommending EU marketing authorization for mCOMBRIAX. According to Moderna, the recommendation is based on Phase 3 data showing non-inferior and in many measures higher immune responses versus co-administered licensed comparators.

What age group and indication does mCOMBRIAX (MRNA) target in the CHMP opinion?

The CHMP opinion covers active immunization for influenza and COVID-19 in adults aged 50 years and older. According to Moderna, the pivotal trial evaluated two cohorts: adults 65+ and adults 50–64, with around 4,000 participants per cohort.

How did mCOMBRIAX perform in Moderna's Phase 3 trial cited by the CHMP?

All primary endpoints demonstrating non-inferiority were met, with statistically higher immune responses for three influenza strains and SARS-CoV-2. According to Moderna, the trial compared mRNA-1083 to co-administered licensed influenza vaccines and Spikevax in both age cohorts.

Is mCOMBRIAX already authorized for use in the European Union after the CHMP opinion?

Not yet; the CHMP opinion recommends authorization but final approval requires a European Commission decision. According to Moderna, once the Commission decides, the authorization would apply across EU and EEA countries pending national access procedures.

Were there any safety concerns reported for mCOMBRIAX in the Phase 3 data shared by Moderna?

Moderna reported an acceptable safety and tolerability profile, with most solicited adverse reactions graded 1 or 2. According to Moderna, safety findings were consistent with the licensed comparator vaccines used in the trial.