Moderna Receives European Commission Marketing Authorization for mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19

Rhea-AI Summary

Moderna (NASDAQ:MRNA) received European Commission marketing authorization for mCOMBRIAX (mRNA-1083) on April 21, 2026, the world's first combined influenza and COVID-19 mRNA vaccine for adults 50 and older. Phase 3 results met non-inferiority endpoints and showed higher immune responses versus co-administered comparators. The vaccine demonstrated an acceptable safety profile and will be rolled out across the EU subject to national regulatory and access procedures.

Positive

• EC marketing authorization granted for mCOMBRIAX (world's first flu+COVID combo)
• Pivotal Phase 3 met all primary non-inferiority endpoints
• Statistically higher immune responses vs co-administered comparators for key strains and SARS-CoV-2
• Fourth authorized Moderna product, expanding respiratory portfolio

Negative

• Authorization limited to adults 50 years and older
• No statistically higher response vs comparator for B/Yamagata in 65+ cohort
• EU availability subject to national regulatory and access procedures, which may delay rollout

News Market Reaction – MRNA

-0.66%

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$20.68B Market Cap

0.1x Rel. Volume

In the Apr 21 session, MRNA declined 0.66%, reflecting a mild negative market reaction. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement confirms full European Commission marketing authorization for mCOMBRIAX, the first...

Analysis

This announcement confirms full European Commission marketing authorization for mCOMBRIAX, the first combination influenza and COVID-19 vaccine for adults 50+, based on a pivotal Phase 3 trial of roughly 4,000 participants per cohort. It expands Moderna’s roster to four authorized products and deepens its respiratory portfolio in the EU. Investors may watch future uptake data, national access decisions, and additional respiratory and oncology readouts to gauge the broader platform trajectory.

Key Figures

Target age group: 50 years of age and older Older adult cohort: 65 years of age and older Younger adult cohort: 50 to 64 years of age +5 more

8 metrics

Target age group 50 years of age and older Indication for mCOMBRIAX immunization

Older adult cohort 65 years of age and older Phase 3 trial cohort comparison arm

Younger adult cohort 50 to 64 years of age Phase 3 trial cohort comparison arm

Phase 3 cohort size approximately 4,000 adults each Two independent age cohorts in pivotal trial

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

EU member states 27 European Union member states Scope of EC marketing authorization

ClinicalTrials.gov ID NCT06097273 Identifier for pivotal Phase 3 trial of mRNA-1083

Primary endpoints All primary endpoints met Non-inferiority of immune responses for mRNA-1083

Previous Covid-19 Reports

5 past events · Latest: Feb 27 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Feb 27	CHMP positive opinion	Positive	+3.6%	CHMP backed EU authorization for first flu plus COVID combo vaccine mCOMBRIAX.
Feb 17	EC vaccine approval	Positive	+4.0%	EC granted marketing authorization for COVID-19 vaccine mNEXSPIKE across EU and EEA.
Dec 15	CHMP positive opinion	Positive	+1.6%	CHMP recommended EU authorization of mNEXSPIKE after Phase 3 efficacy data.
Sep 16	Variant efficacy data	Positive	+4.0%	Updated Spikevax generated strong antibody response vs LP.8.1 with broad approvals.
Aug 22	Health Canada approval	Positive	+3.4%	Health Canada approved updated Spikevax targeting LP.8.1 with domestic production.

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

Pattern Detected

Recent covid-19 regulatory and efficacy updates have consistently coincided with modest positive moves, averaging about 3.33% over 5 events, suggesting the market typically reacts constructively to similar announcements.

Recent Company History

Over the past year, Moderna has repeatedly advanced its COVID-19 franchise in Europe and globally. The CHMP’s positive opinion on mCOMBRIAX on Feb 27, 2026 and earlier recommendations and approvals for mNEXSPIKE drew same-day gains between 1.56% and 4.03%. Additional COVID-19 updates on variant-targeted Spikevax and international approvals also produced single‑digit positive reactions. Today’s EC marketing authorization for mCOMBRIAX extends this pattern from recommendation to full approval within the EU.

Key Terms

marketing authorization, Committee for Medicinal Products for Human Use, Phase 3 clinical trial, randomized, observer-blind, active-controlled study, +4 more

8 terms

marketing authorization regulatory

"the European Commission (EC) has granted marketing authorization 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.

Committee for Medicinal Products for Human Use regulatory

"follows the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP)"

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.

Phase 3 clinical trial medical

"The EC's authorization is based on the results from the pivotal Phase 3 clinical trial"

A phase 3 clinical trial is a large-scale study that tests a new medical treatment or drug to determine if it is safe and effective for widespread use. It often involves hundreds or thousands of participants and compares the new treatment to existing options or a placebo. For investors, the results of this phase are crucial, as successful outcomes can lead to regulatory approval and commercial success, while failures may halt development.

randomized, observer-blind, active-controlled study medical

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

A clinical trial design where participants are placed into treatment groups by chance (randomized), the people evaluating outcomes do not know which treatment each person received (observer-blind), and the new treatment is compared against an existing therapy rather than a dummy pill (active-controlled). For investors, this setup reduces bias and gives more reliable evidence about whether a drug or device actually works and is safe, which influences regulatory approval, market uptake, and commercial value.

immunogenicity medical

"evaluating the safety, reactogenicity, and immunogenicity of mRNA-1083"

Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.

non-inferiority medical

"All primary endpoints demonstrating the non-inferiority of immune responses were met."

A non-inferiority trial is a type of clinical test designed to show a new treatment is not meaningfully worse than an existing standard by more than a pre-set, acceptable amount. Think of it like proving a new smartphone model has battery life close enough to the leading model while offering other advantages; for investors, a successful non-inferiority result can clear the way to regulatory approval and market uptake even when the new option isn’t superior in headline effectiveness.

SARS-CoV-2 medical

"prevention of influenza disease 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.

adverse reactions medical

"The majority of solicited adverse reactions were grade 1 or 2 in severity"

Adverse reactions are harmful or unintended effects people experience after using a medicine, vaccine, medical device, or treatment; think of them as unexpected problems that show up when a product is used as intended. Investors care because these reactions can trigger regulatory warnings, safety reviews, recalls, reduced sales, or legal costs—similar to how widespread product defects can damage a company’s reputation and future earnings.

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

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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 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:

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, 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 April 21, 2026 about mCOMBRIAX authorization?

Moderna announced that the European Commission authorized mCOMBRIAX for adults 50 and older. According to the company, the authorization follows a positive EMA CHMP opinion and covers all 27 EU member states plus Iceland, Liechtenstein and Norway.

How did mCOMBRIAX perform in the Phase 3 trial cited by Moderna (MRNA)?

mCOMBRIAX met all primary non-inferiority immune endpoints in the Phase 3 trial. According to the company, it elicited statistically higher responses against three influenza strains and SARS-CoV-2 across both age cohorts versus co-administered comparators.

What safety profile did Moderna (MRNA) report for mCOMBRIAX in the approval announcement?

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

Which age groups are covered by the European authorization for mCOMBRIAX (MRNA)?

The authorization covers individuals 50 years of age and older. According to the company, the pivotal study included two cohorts: adults 50–64 and adults 65 and older, both evaluated in the Phase 3 trial.

Will mCOMBRIAX be immediately available across the EU after Moderna's (MRNA) approval?

mCOMBRIAX will be made available across the EU but subject to national procedures. According to the company, access and implementation depend on national regulatory and access processes in each member state.