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Moderna's mFLUSIVA receives FDA approval as first mRNA flu vaccine
The U.S. Food and Drug Administration (FDA) has approved Moderna's mFLUSIVA, the first seasonal influenza vaccine to utilize messenger RNA (mRNA) technology. The vaccine is authorized for adults aged 50 and older, with full approval granted for those aged 50–64 and accelerated approval for individuals 65 and older.
Clinical trials involving more than 40,000 participants showed that mFLUSIVA was approximately 26.6% to 27% more effective than standard-dose flu vaccines. A key advantage of the mRNA platform is its speed; Moderna can transition from strain selection to production in two to three months, significantly faster than the six-month cycle required for traditional egg-based vaccines.
The approval comes amid a complex political climate. While mRNA technology was vital during the COVID-19 pandemic, it has faced scrutiny from Health and Human Services Secretary Robert F. Kennedy Jr., who has criticized the technology and previously canceled several federal mRNA development projects. The FDA had initially declined to review the application due to trial design concerns but later reversed its decision following a dispute from Moderna.
Entities
Centers for Disease Control and Prevention · FDA · Moderna · Moderna Inc. · Robert F. Kennedy Jr. · U.S. Food and Drug Administration · United States · mFLUSIVA
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 5 SOURCES] Moderna expects mFLUSIVA to be available for the 2026-2027 respiratory virus season. www.brasilemfolhas.com.br · eenergetica.com.ar · exitonoticias.com.bo · www.nouvelles-du-monde.com · www.lpm.org
- [● 5 SOURCES] The FDA initially refused to review Moderna's application before reversing its decision following a dispute from the company. eenergetica.com.ar · exitonoticias.com.bo · www.presidentialprayerteam.org · udgtv.com · www.lpm.org
- [● 5 SOURCES] As Health and Human Services Secretary, Robert F. Kennedy Jr. has criticized mRNA technology and previously canceled 22 federal mRNA vaccine development projects. exitonoticias.com.bo · www.presidentialprayerteam.org · udgtv.com · www.lpm.org · www.world-today-news.com
- [● 2 SOURCES] The mRNA platform allows for a production timeline of two to three months from strain selection, compared to six months for traditional egg-based vaccines. www.everydayhealth.com · www.world-today-news.com
- [● 4 SOURCES] mFLUSIVA was granted full approval for adults aged 50 to 64 and accelerated approval for those aged 65 and older. www.brasilemfolhas.com.br · www.nouvelles-du-monde.com · www.presidentialprayerteam.org · www.everydayhealth.com
- [● 4 SOURCES] In a study of over 40,000 participants, mFLUSIVA was approximately 26.6% to 27% more effective than standard-dose flu vaccines. www.brasilemfolhas.com.br · eenergetica.com.ar · www.nouvelles-du-monde.com · www.world-today-news.com
- [● 2 SOURCES] Reported side effects included injection-site pain, fatigue, headache, muscle aches, nausea, and fever. eenergetica.com.ar · www.nouvelles-du-monde.com
- [● 10 SOURCES] The FDA approved Moderna's mRNA-based influenza vaccine, mFLUSIVA, for adults aged 50 and older. www.brasilemfolhas.com.br · eenergetica.com.ar · exitonoticias.com.bo · www.nouvelles-du-monde.com · www.presidentialprayerteam.org · +5 more