IR Insights: Introducing mFLUSIVA – A Milestone for Moderna's Respiratory Portfolio
Today marks an important milestone with the U.S. FDA approval of mFLUSIVA® (mRNA-1010), our influenza vaccine for adults 50 years of age and older. For adults 65 years of age and older, approval was based on a study showing that mFLUSIVA helped the immune system respond, with additional research ongoing to confirm the clinical benefit. This is Moderna's fifth approved product and the first mRNA-based influenza vaccine approved by the FDA.
I sat down for an episode of IR Insights alongside Moderna President Stephen Hoge to provide our perspective on what this achievement means for our company:
VRBPAC: The Need for Modern Solutions for Flu
Flu remains a significant public health burden in the United States. During the 2024–2025 season, more than 45,000 Americans died from influenza, while flu-related hospitalizations and outpatient visits reached their highest levels in 15 years. While they make up less than 20 percent of the total U.S. population, people 65 years and older account for an estimated 70-85 percent of flu-related deaths and 50-70 percent of flu-related hospitalizations.
Modernizing the development and production of influenza vaccines has long been a public health priority, and today's approval of an mRNA-based flu vaccine marks an important step toward a more modern approach. That potential was recently discussed by the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC), whose members voted unanimously that mFLUSIVA's benefits outweigh its risks for adults 50 years of age and older.
Our Expanding Respiratory Portfolio
Today's approval also represents another important step in building Moderna's respiratory franchise. We now have approved products spanning COVID-19, RSV and influenza, along with a COVID + Flu combination vaccine approved in Europe. Each milestone builds on the foundation created by teams across Moderna who continue translating the promise of mRNA into approved medicines.
I want to thank the thousands of clinical trial participants who volunteered their time, the investigators and clinical site teams who conducted these studies, the regulatory authorities who reviewed our submission, and the many Moderna employees whose dedication made this achievement possible. Developing a new medicine is always a team effort, and this approval reflects the commitment, perseverance and collaboration of people across our company and throughout the broader scientific and medical community.
Looking ahead, we expect mFLUSIVA to be available in the United States for eligible adults during the 2026–2027 respiratory virus season. Beyond the U.S., regulatory submissions are under review in the European Union, Canada and Australia, with additional submissions planned later this year. We remain committed to advancing our respiratory portfolio and to applying our mRNA platform to address important public health challenges around the world.
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 http://vaers.hhs.gov.
Please click for mFLUSIVA Full Prescribing Information and Information for Recipients and Caregivers.
Forward-Looking Statements
This post and accompanying video contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: ongoing research to confirm the clinical benefit of mFLUSIVA; the opportunities and potential benefits unique to mFLUSIVA; Moderna’s expanding respiratory franchise; the availability of mFLUSIVA during the 2026-2027 respiratory virus season; Moderna’s pending and anticipated regulatory submissions and potential approvals; and the potential of Moderna’s mRNA platform. 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 post 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 post 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 post.