mCOMBRIAX is the world&#39;s first flu plus COVID combination vaccine to receive marketing authorization and Moderna&#39;s fourth authorized productmCOMBRIAX will be made available in the European Union, subject to national

mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized productmCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures CAMBRIDGE, MA / <a href='https://www.accessnewswire.com/'>ACCESS Newswire</a> / April 21, 2026 / Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/MRNA">MRNA</a>) today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX&#xAE; (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 <a rel="nofollow" href="https://pr.report/kuf3">the positive opinion</a> 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 <a rel="nofollow" href="https://pr.report/kuf4">mNEXSPIKE&#xAE;</a>, Moderna's COVID-19 vaccine, and <a href="https://www.newswire.com/news/moderna-announces-positive-phase-3-results-for-seasonal-influenza-vaccine">mRNA-1010</a>, 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: <a rel="nofollow" href="https://pr.report/kuf5">NCT06097273</a>), 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&#xAE; (licensed in the European Union as Efluelda&#xAE;), a high-dose influenza vaccine, and Spikevax&#xAE;, 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&#xAE;, 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 ModernaModerna 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 <a rel="nofollow" href="https://pr.report/hn3n">modernatx.com</a> and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.mCOMBRIAX&#xAE;, mNEXSPIKE&#xAE; and Spikevax&#xAE; are registered trademarks of Moderna.Fluzone HD&#xAE; and Efluelda&#xAE; are registered trademarks of Sanofi Pasteur.Fluarix&#xAE; is a registered trademark of the GlaxoSmithKline group of companies.Forward-Looking StatementsThis 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 <a href="http://www.sec.gov" title="www.sec.gov">www.sec.gov</a>. 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 ContactsMedia:Global:Chris Ridley Vice President, Global Head of Communications +1 617-800-3651 <a rel="nofollow" href="mailto:Chris.Ridley@modernatx.com">Chris.Ridley@modernatx.com</a>EU:Clothilde Caillet Director, Country and Europe Communications Lead (+33) 07 60 87 68 72 <a rel="nofollow" href="mailto:Clothilde.caillet@modernatx.com">Clothilde.caillet@modernatx.com</a>Investors:Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 <a rel="nofollow" href="mailto:Lavina.Talukdar@modernatx.com">Lavina.Talukdar@modernatx.com</a>[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, <a rel="nofollow" href="https://pr.report/kuf6">https://jamanetwork.com/journals/jama/fullarticle/2833668</a>SOURCE: Moderna, Inc. View the original <a href='https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/moderna-receives-european-commission-marketing-authorization-for-mcom-1159402'>press release</a> on ACCESS Newswire 
 <img src="https://app.accessnewswire.com/img.ashx?id=1159402" width="0" height="0"/>

MRNA

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

Moderna's mCOMBRIAX Receives EU Marketing Authorization, Boosting Product Portfolio

Moderna said ​on Tuesday ‌the European ​Commission ​had granted marketing ⁠authorization ​for a ​com...

Moderna wins EU approval for combined flu, COVID shot for older adults

<section class="insight" data-version="1">
 <section data-block="information">
 <h3>Information</h3>
 mCOMBRIAX is the world&amp;#39;s first flu plus COVID combination vaccine to receive marketing authorization and Moderna&amp;#39;s fourth authorized productmCOMBRIAX will be made available in the European Union, subject to national
 </section>

 <section data-block="ai-summary-paragraph">
 <h3>AI Summary</h3>
 The European Commission has granted marketing authorization for Moderna&#039;s mCOMBRIAX, combining flu and COVID-19 protection for older adults. This approval strengthens Moderna&#039;s respiratory portfolio and positions the company favorably in the growing market for combination vaccines, potentially increasing revenues and market share. Positive trial results reinforce the vaccine&#039;s promise, driving optimism among investors.
 </section>

 <section data-block="ai-summary-bullets">
 <h3>Key Points</h3>
 <ul><li>Moderna&#039;s mCOMBRIAX is the first flu plus COVID vaccine authorized in Europe.</li><li>Marketing authorization covers all 27 EU member states and additional countries.</li><li>mCOMBRIAX aims to simplify immunizations for high-risk populations aged 50 and older.</li><li>Positive Phase 3 trial results demonstrated superior immune responses compared to comparators.</li><li>Safety profile of mCOMBRIAX aligns with existing licensed vaccines.</li></ul>
 </section>

 <section data-block="companies-mentioned">
 <h3>Companies Mentioned</h3>
 <ul><li>Sanofi (SNY): Fluzone HD is a competitive product in flu vaccination.</li><li>GlaxoSmithKline (GSK): Fluarix poses competitive pressure in the influenza vaccine market.</li></ul>
 </section>

 <section data-block="category">
 <h3>Corporate Developments</h3>
 This news falls under &#039;Corporate Developments&#039; since it relates to regulatory approval and product launches for Moderna&#039;s vaccine offerings, highlighting strategic growth in the company&#039;s portfolio, enhancing its competitive edge in the pharmaceutical market.
 </section>

 <section data-block="market-moving">
 <h3>Market-Moving</h3>
 <ul><li>mCOMBRIAX&#039;s authorization may lead to increased sales in Europe, boosting revenue estimates.</li><li>Potential for broader acceptance could enhance MRNA&#039;s market position amidst growing competition.</li><li>Fulfillment of national regulatory processes will be crucial for timely rollout and revenue impact.</li><li>Positive response to mCOMBRIAX could lead to increasing share price momentum.</li></ul>
 </section>

 <section data-block="key-facts">
 <h3>Key Facts</h3>
 <ul><li>mCOMBRIAX is authorized for individuals aged 50 years and older.</li><li>Authorization is valid across all 27 EU member states plus Norway and Iceland.</li><li>The phase 3 trial involved about 8,000 participants in two age cohorts.</li><li>The vaccine showed statistically significant immune responses against three influenza variants and SARS-CoV-2.</li><li>The product represents Moderna&#039;s fourth authorized vaccine in the EU.</li></ul>
 </section>

 <section data-block="trading-thesis">
 <h3>Trading Thesis</h3>
 Buy MRNA shares anticipating increased revenue from mCOMBRIAX within the next 12 months.
 </section>
</section>


mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive marketing authorization and Moderna's fourth authorized productmCOMBRIAX will be made available in the European Union, subject to national regulatory and access procedures CAMBRIDGE, MA / <a href='https://www.accessnewswire.com/'>ACCESS Newswire</a> / April 21, 2026 / Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/MRNA">MRNA</a>) today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX&#xAE; (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 <a rel="nofollow" href="https://pr.report/kuf3">the positive opinion</a> 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 <a rel="nofollow" href="https://pr.report/kuf4">mNEXSPIKE&#xAE;</a>, Moderna's COVID-19 vaccine, and <a href="https://www.newswire.com/news/moderna-announces-positive-phase-3-results-for-seasonal-influenza-vaccine">mRNA-1010</a>, 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: <a rel="nofollow" href="https://pr.report/kuf5">NCT06097273</a>), 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&#xAE; (licensed in the European Union as Efluelda&#xAE;), a high-dose influenza vaccine, and Spikevax&#xAE;, 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&#xAE;, 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 ModernaModerna 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 <a rel="nofollow" href="https://pr.report/hn3n">modernatx.com</a> and connect with us on X, Facebook, Instagram, YouTube and LinkedIn.mCOMBRIAX&#xAE;, mNEXSPIKE&#xAE; and Spikevax&#xAE; are registered trademarks of Moderna.Fluzone HD&#xAE; and Efluelda&#xAE; are registered trademarks of Sanofi Pasteur.Fluarix&#xAE; is a registered trademark of the GlaxoSmithKline group of companies.Forward-Looking StatementsThis 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 <a href="http://www.sec.gov" title="www.sec.gov">www.sec.gov</a>. 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 ContactsMedia:Global:Chris Ridley Vice President, Global Head of Communications +1 617-800-3651 <a rel="nofollow" href="mailto:Chris.Ridley@modernatx.com">Chris.Ridley@modernatx.com</a>EU:Clothilde Caillet Director, Country and Europe Communications Lead (+33) 07 60 87 68 72 <a rel="nofollow" href="mailto:Clothilde.caillet@modernatx.com">Clothilde.caillet@modernatx.com</a>Investors:Lavina Talukdar Senior Vice President & Head of Investor Relations +1 617-209-5834 <a rel="nofollow" href="mailto:Lavina.Talukdar@modernatx.com">Lavina.Talukdar@modernatx.com</a>[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, <a rel="nofollow" href="https://pr.report/kuf6">https://jamanetwork.com/journals/jama/fullarticle/2833668</a>SOURCE: Moderna, Inc. View the original <a href='https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/moderna-receives-european-commission-marketing-authorization-for-mcom-1159402'>press release</a> on ACCESS Newswire 
 <img src="https://app.accessnewswire.com/img.ashx?id=1159402" width="0" height="0"/>

The European Commission has granted marketing authorization for Moderna's mCOMBRIAX, combining flu and COVID-19 protection for older adults. This approval strengthens Moderna's respiratory portfolio and positions the company favorably in the growing market for combination vaccines, potentially increasing revenues and market share. Positive trial results reinforce the vaccine's promise, driving optimism among investors.

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

AI Summary

Sentiment Rationale

Trading Thesis

Market-Moving

Key Facts

Companies Mentioned

Corporate Developments

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