Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVAhttps://feeds.issuerdirect.com/news-release.html?newsid=4801915282452025&symbol=MRNACAMBRIDGE, 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.
1. This is full FDA approval, not Emergency Use Authorization (which would not have been allowed wrt Flu viruses).
2. Approval was based on over 3 years of a general population Phase 3 clinical trial and ~1 3/4 of a year of a linked Phase 3 trial with recipients age >50YO. Prior to Phase 3 were more limited Phase 1 and 2 trials with human volunteers, meaning human trials have been underway since 2021 (I checked).
3. The Phase 3 trials compared mRNA-1010 to existing flu vaccine as well as testing effectiveness and safety generally.
4. The mFLUSIVA® (mRNA-1010) vaccine targets multiple flu virus variants, possibly bypassing the annual months-long process of guesstimating what flu strains will be circulating during flu season and producing enough vaccine doses for what might or might not be effective during flu season.
5. There will be an ongoing Phase 4, in which effectiveness and safety are monitored.
6. Yes, this vaccine uses bogey-mRNA.
