The Fort Worth Press - Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA

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 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
[email protected]

Investors:

Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
[email protected]

SOURCE: Moderna, Inc.

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S.Palmer--TFWP