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The Food and Drug Administration has approved a first-of-its-kind flu vaccine made with messenger RNA technology, enabling its developer, Moderna, to complete a dramatic regulatory turnaround.The agency on Wednesday approved mFlusiva, previously known as mRNA-1010,for use against seasonal influenza in all adults at least 50 years of age. The shots clearance in those 65 or older was handed out under an accelerated approval thats contingent on results from a postmarketing study. Moderna previously disclosed that its already aligned with regulators on the framework of that trial, which will take place over the course of two flu seasons.“Flu remains a significant public health challenge, and mFlusiva provides an important new option for America's seniors,said Moderna CEO Stphane Bancel, in a statement.This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation.Like the rest of Modernas pipeline, mFlusiva is built on mRNA technology capable of being weaponized against emerging pathogens more quickly than traditional vaccines. That speed advantage helped Moderna bring one of the first COVID-19 vaccines to market during the pandemic, and made Moderna a household name.Sales of that COVID-19 vaccine have fallen considerably since then, and even with other product approvals, Moderna has struggled to find another big seller. Its long hoped mFlusiva could be a big part of the solution, given current flu shots are based on a slower production process that relies more heavily on expert guesswork to determine which viral strains to target.That vaccine, though, has faced an unusual and tumultuous regulatory path.Moderna first sought clearance of a combination COVID and flu shot, but abandoned that plan after U.S. regulators requested additional data from its influenza component. Moderna gathered those results, which were published in the New England Journal of Medicineand showed that, when compared to a standard-dose flu vaccine, mFlusiva reduced the likelihood of influenza-like illness by 27% in adults 50 years of age or older. Yet the FDA led at the time by Marty Makary and top deputy Vinay Prasad refused to review the application.The unusual decision drew public backlash, though, and the agency quickly reversed courseafter a formal meeting with Moderna. And Prasad and Makary, who had enacted stricter vaccine approval guidelines, have both since left the FDA. Interim leaders have appeared to take a friendlier stance on multiple other delayed or previously spurned drug applications, heightening Modernas chances at a comeback.In June, an FDA advisory committee then threw unanimous support behind mFlusiva. The panelists determined that the benefits of vaccination with Modernas shot outweigh the risks in adults between 50 and 64 years of age. They were also supportive of use in those 65 and older, despite agency reviewers concernswith certain gaps in the evidence Moderna had accumulated. The confirmatory study is meant to address those issues.No new or serious safety concerns were identified by either Moderna or FDA staff reviewers. Adverse reactions consistent with mRNA vaccines, such as fatigue, joint pain and muscle aches, were recorded in the trial.The studies that were presented today were very well conducted. They have very clear results that are very robust, said Flor Munoz-Rivas, a panelist and associate professor of pediatrics and infectious disease at Baylor College of Medicine, at the meeting. An approval would help the U.S. be better prepared for emerging strains or pandemic strains in the future.Moderna expects mFlusiva to be available in the U.S. for the upcoming 2026-2027 flu season. The shot is under review in Europe, Canada and Australia, and other submissions are planned this year. '

mFLUSIVA becomes Moderna's fifth approved product globally and fourth FDA-approved product Company expects supply to be available in select retailers in the coming weeks CAMBRIDGE, MA / ACCESS Newswire / August 5, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mFLUSIVA® (mRNA-1010), a new vaccine against seasonal influenza, for use in all adults 50 years and older. This approval follows unanimous recommendations from the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) supporting mFLUSIVA for adults 50 years of age and older. "The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna. "Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible." ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); The FDA's approval of mFLUSIVA in adults 50 through 64 years of age is based on results from a randomized, observer-blind, active-controlled, Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06602024 ), which enrolled 40,805 adults aged 50 years and older across 11 countries. The primary objectives in this study were to evaluate the safety and reactogenicity of mFLUSIVA, and to evaluate relative vaccine efficacy (rVE) of mFLUSIVA versus a standard dose (SD) active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains. Use in adults 65 years of age and older was granted accelerated approval based on results from a randomized, observer-blind, active-controlled clinical trial (ClinicalTrials.gov Identifier: NCT05827978 ), which enrolled 2,992 adults 65 years of age and older in the United States. The primary objective in this study was to evaluate the immunogenicity of mFLUSIVA versus a high-dose (HD) inactivated influenza vaccine comparator. The effectiveness of mFLUSIVA in adults 65 years of age and older is also supported by the descriptive analysis of rVE in the randomized, observer-blind, active-controlled, Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT06602024 ). Confirmation of clinical benefit in this population will be assessed in a postmarketing clinical trial. The Phase 3 program demonstrated an acceptable safety pro mFLUSIVA, with no new safety concerns identified, consistent with previously reported studies of mFLUSIVA. Moderna expects to have mFLUSIVA available for eligible populations in the U.S. for the 2026-2027 respiratory virus season, alongside Spikevax® (COVID-19 Vaccine, mRNA), mRESVIA® (Respiratory Syncytial Virus Vaccine) and mNEXSPIKE® (COVID-19 Vaccine, mRNA). mRNA-1010 has been accepted for regulatory review in the European Union, Canada and Australia. Regulatory submissions in additional countries are planned during 2026. 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.   mFLUSIVA®, mNEXSPIKE®, mRESVIA® and Spikevax® are registered trademarks of Moderna. INDICATION What is mFLUSIVA® (Influenza vaccine, mRNA)? mFLUSIVA is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine. mFLUSIVA is approved for use in persons 50 years of age and older. The indication for persons 65 years of age and older is approved under accelerated approval based on immune responses. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. IMPORTANT SAFETY INFORMATION You should not get mFLUSIVA if you had a severe allergic reaction to any ingredient in mFLUSIVA. Tell your healthcare provider about all of your medical conditions, including if you: have any allergies or have had a severe allergic reaction after receiving a previous dose of any other vaccine have had Guillain-Barré syndrome (severe muscle weakness) after getting an influenza vaccine are immunocompromised or are on a medicine that affects your immune response are breastfeeding, pregnant or plan to become pregnant have ever fainted in association with an injection What are the risks of mFLUSIVA? Severe allergic reactions are rare but can happen after vaccination with mFLUSIVA. If a severe allergic reaction occurs, it would usually happen within minutes to one hour after a dose of mFLUSIVA. Because of this, your healthcare provider may ask you to stay for a short time after your vaccination. Side effects that have been reported in clinical trials with mFLUSIVA include: Injection site reactions: pain, tenderness and swelling of the lymph nodes in the same arm as the injection, swelling (hardness), and redness. General side effects: fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, and fever. These may not be all the possible side effects of mFLUSIVA. Ask your healthcare provider about any side effects that concern you. You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or . Please click for mFLUSIVA Full Prescribing Information and Information for Recipients and Caregivers . Moderna 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 mFLUSIVA in the U.S. for the 2026-2027 respiratory season; the results of postmarketing clinical studies for mFLUSIVA; ongoing regulatory review in the European Union, Canada and Australia; and planned regulatory submissions in additional countries. 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 SOURCE: Moderna, Inc. View the original press release on ACCESS Newswire