Elasomeran

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 pro 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 . 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, SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire

iStock, Vladimir Mandic The CDC’s changes threaten to cut vaccine sales for makers including Pfizer, Moderna, Merck and more, but a legal expert suspects affected manufacturers will stay on the sidelines rather than back a push to declare the revised schedule unlawful. As 15 states sue the Department of Health and Human Services over changes to the childhood immunization schedule, it remains unclear whether manufacturers with sales threatened by the update will lend their voice to the legal challenge or stay on the sidelines. Vaccine makers that could be affected include Pfizer, Moderna, Merck, GSK, Sanofi and others. Dorit Reiss, professor of law at UC Law San Francisco, noted in an email to BioSpace that manufacturers have not filed amicus briefs in support of the case the American Academy of Pediatrics (AAP) brought last year against HHS, Robert F. Kennedy Jr. and other people and organizations behind earlier changes to the recommended immunization schedules for children and pregnant women. The AAP case focuses on the May 2025 decision to remove COVID-19 vaccines from the list of products recommended for healthy children and pregnant women. Last week, 15 states led by Democrats brought a new case against the HHS, Kennedy and others. That case challenges the CDC’s recent decision to reduce the routine childhood and adolescent immunization schedule from targeting 17 diseases to 11. Some vaccine manufacturers have expressed concerns about the changes. Thomas Triomphe, Sanofi’s executive vice president of vaccines, said on an earnings call in January that the “sudden shift” to the new schedule will create confusion for parents and healthcare providers. Guggenheim Securities analysts cut their estimates for U.S. sales of Merck’s Gardasil in 2026 and beyond in response to the changes. The potential for the revised immunization schedule to cut sales creates an incentive for companies to support the states’ challenge by filing amicus briefs. Yet Reiss said pharma companies “may reasonably think it’s better to stay away, given their lack of popularity.” While noting that she has no inside information, the professor said that she would guess manufacturers will opt against filing amicus briefs. Vaccines Vaccine Investors Keep Their Heads Down as Trump Cuts Shot Schedule The US dramatically altered its recommendations for a series of vaccines, which drive billion-dollar earnings for giants like Merck and Pfizer. January 6, 2026 · 3 min read · Dan Samorodnitsky Read more Reiss expects the public health organizations that filed briefs for the AAP case to submit amici in support of the 15 states’ case against the HHS and RFK Jr. The AAP case docket includes eight amicus filings signed by more than 100 public health experts and organizations such as the American Association of Immunologists, the American College of Obstetricians & Gynecologists and Defend Public Health. The 15 states’ case covers the COVID-19 vaccine change made last May, which the CDC incorporated into the updated immunization schedule in January. In their lawsuit, the states called the new schedule the “culmination of a series of unlawful actions in furtherance of Secretary Kennedy’s idiosyncratic and unscientific hostility to vaccines.” The states seek to get the schedule and changes to the membership of the Advisory Committee on Immunization Practices (ACIP) declared unlawful. The states claim appointing “unqualified ACIP members” and bypassing the committee to create the new immunization schedule were “arbitrary and capricious and contrary to law.”