mRNA-1083

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, hapabapa The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to-File letter in response to its application for mRNA-1010. Moderna will now seek approval of the vaccine based on age. The FDA will review Moderna’s mRNA-based influenza vaccine prior to the start of the 2026-2027 flu season after all. The company announced Wednesday that the two parties have reached an agreement on an amended filing for the candidate, after the FDA originally refused to consider the candidate last week. Following receipt of a Refusal-to-File (RTF) letter—which Moderna revealed on February 10—the company quickly met with the FDA in a Type A meeting. This resulted in the agency accepting Moderna’s proposal of a regulatory pathway based on age, in which it will full approval of mRNA-1010 for adults 50 to 64 years, and accelerated approval for those 65 and older. Vaccines FDA Refuses To Review Moderna’s mRNA Flu Vaccine, Claims Trial Inadequacies After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010. February 11, 2026 · 4 min read · Tristan Manalac In the RTF —which Moderna took the unusual step of publishing with redactions on its website—the FDA claimed that Moderna failed to support mRNA-1010’s application with an “adequate and well-controlled” trial. The main point of contention, however, had to do with older adults. The agency had recommended in 2024 that Moderna use a comparator high-dose vaccine preferentially recommended for older adults by the CDC’s Advisory Committee on Immunization Practices. Moderna submitted data on a high-dose vaccine tested in adults aged 65 and older at the FDA’s request in August 2025. “Moderna exposed participants age 65 and over to increased risk of severe illness by giving them a substandard of care against the recommendation of FDA scientists,” Department of Health and Human Services spokesperson Andrew Nixon said during a press call last Wednesday, according to Scientific American . “The most protective flu shots for seniors are a subset of high-dose flu shots recommended by the [ACIP], which would have served as the proper control in this study.” The FDA has now accepted Moderna’s amended biologics license application (BLA) for review, with a target action date of August 5. “We appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement on Wednesday. Moderna’s shares rose more than 8.5% to $47.67 as the market opened on Wednesday morning. Back On Track The rapid turnaround comes amid a particularly challenging flu season in the U.S. due to a mismatch in circulating strains as compared to the existing shots. Moderna believes its mRNA technology—which uses a faster production process than traditional vaccines—could solve this dilemma. “We do think this year in particular, where there’s a potential for a mismatch in one of the strains, it’s particularly important that technologies like Moderna’s mRNA platform are used to advance new and potentially improved products,” Stephen Hoge, the company’s president and R&D chief, said during a fourth-quarter earnings call on Friday. Vaccines Moderna’s mRNA Tech Could Boost Flu Shot Efficacy. Americans Will Have To Wait After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology. February 16, 2026 · 3 min read · Annalee Armstrong The RTF had thrown Moderna’s quest to reach breakeven status by 2028 into question, with William Blair saying in a February 11 note that following the news, they were reworking their models of Moderna’s future potential earnings on the fly. mRNA-1010 is expected to contribute billions in revenue, along with the company’s combo flu/COVID vaccine mRNA-1083. Moderna had been waiting for the regulatory process for mRNA-1010 to advance before moving an application forward for the combo vaccine. Now, order may be restored. On Wednesday, Jefferies noted that by 2027-28, Moderna could launch seven or more products in the respiratory, oncology and rare disease spaces. “Continued cost reductions could allow MRNA to achieve cash breakeven guidance by 2028,” the analysts wrote. The 8-day resolution to the mRNA-1010 imbroglio is reminiscent of the turnaround that essentially ended the FDA’s back-and-forth with Sarepta Therapeutics last summer. After requesting that Sarepta discontinue shipments of its Duchenne muscular dystrophy gene therapy Elevidys on July 21, the regulator reversed course just over a week later, recommending that the voluntary hold be lifted for ambulatory patients. Like Moderna’s RTF for mRNA-1010, 2025’s Sarepta saga played out prolifically in the media.