Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA
Rhea-AI Summary
Moderna (NASDAQ:MRNA) received full U.S. FDA approval for mFLUSIVA (mRNA‑1010), an mRNA-based seasonal influenza vaccine indicated for adults 50 years and older. This is Moderna’s fifth approved product globally and fourth FDA-approved product, and the first mRNA flu vaccine approved in the U.S.
Approval in adults 50–64 is supported by a randomized Phase 3 trial (40,805 participants) evaluating safety, reactogenicity and relative vaccine efficacy versus a standard-dose comparator. Use in adults 65+ is under accelerated approval based on immunogenicity data from a separate randomized trial (2,992 participants), with clinical benefit to be confirmed postmarketing. The Phase 3 program showed an acceptable safety profile with no new safety concerns identified. Moderna expects U.S. supply for eligible populations in the 2026–2027 respiratory virus season and has regulatory reviews underway in the EU, Canada and Australia.
Positive
- FDA approval of mFLUSIVA for adults 50+ in the U.S.
- mFLUSIVA becomes Moderna’s fifth approved product globally and fourth FDA-approved product
- Phase 3 program in adults 50+ enrolled 40,805 participants across 11 countries
- Adults 65+ indication granted accelerated approval based on immunogenicity data
- Phase 3 data showed an acceptable safety profile with no new safety concerns identified
- Expected U.S. availability for the 2026–2027 respiratory virus season alongside other respiratory products
Negative
- Adults 65+ indication is under accelerated approval and depends on confirmatory clinical benefit data
- Label highlights risk of rare severe allergic reactions requiring observation after vaccination
- Clinical trials reported local and systemic side effects such as injection site pain, fatigue and headache
News Explained
Moderna expects mFLUSIVA to reach select U.S. retailers in the coming weeks, adding a near-term commercialization milestone to its FDA approval for adults 50 and older.
Market reaction after mFLUSIVA FDA approval: MRNA -4.26% in the Aug 6 session
In the Aug 6 session, MRNA declined 4.26%, reflecting a moderate negative market reaction. Argus tracked a trough of -9.4% from its starting point during tracking. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Fda approval Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 12 | FDA approval | Positive | -2.5% | RSV vaccine approval for adults 18–59 at increased risk for disease |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
The only tag-matched prior FDA approval declined 2.49% over 24 hours, diverging from the approval's positive substance.
Key Terms
fda approval regulatory
phase 3 clinical trial medical
accelerated approval regulatory
reactogenicity medical
immunogenicity medical
rt-pcr technical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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."
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 profile for 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 http://vaers.hhs.gov.
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 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 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