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FDA Rejects Moderna’s New mRNA Flu VaccineModerna’s flu vaccine was denied review amid a severe 2026 flu season with over 22 million cases in the U.S.
Key FactsFeb 11, 2026 · Reading time: ~45 sec.
Summary created with AI assistance · Source: scientificamerican.com
Summary created with AI assistance · Source: scientificamerican.com
- The FDA declined to review Moderna’s new mRNA flu vaccine without citing safety or efficacy issues.
- The refusal was due to Moderna not conducting trials comparing its vaccine to the CDC-recommended standard shot.
- Officials warned that seniors were placed at higher risk by receiving suboptimal protection during trials.
- Virologists highlight the adaptability of mRNA vaccines to quickly target emerging flu variants like subclade K.
If we had recognized that [subclade K] was going to be driving things, and we were using mRNA vaccines instead of conventional flu vaccine technology platforms, we would potentially be able to make an updated flu shot in time for flu season.— Angie Rasmussen, a virologist at the University of Saskatchewan, discusses the adaptability of mRNA vaccines.
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Key FactsFDA Reverses Course on Moderna’s mRNA Flu Vaccine
Feb 18, 2026 · Reading time: ~45 sec.
Summary created with AI assistance · Source: cnbc.com
Summary created with AI assistance · Source: cnbc.com
- The FDA agreed to review Moderna’s previously rejected application for its mRNA flu vaccine.
- Moderna seeks full approval for adults aged 50-64 and accelerated approval for those 65 and older.
- An additional post-marketing study in older adults is required following approval.
- The reversal came after a productive FDA meeting and a revised trial design addressing regulatory concerns.
We're hopeful and optimistic about the platform but would also like to see the data.— FDA Commissioner Dr. Marty Makary expressed his views on mRNA technology in the context of vaccine development.
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Key FactsModerna’s Flu Vaccine Surpasses Traditional Shot Effectiveness
Jun 30, 2025 · Reading time: ~45 sec.
Summary created with AI assistance · Source: theglobeandmail.com
Summary created with AI assistance · Source: theglobeandmail.com
- Moderna’s experimental mRNA-1010 flu vaccine proved 26.6% more effective than GSK’s approved shot in adults aged 50 and older.
- In adults 65 and above, the vaccine’s efficacy was 27.4% higher, targeting the group most at risk for severe flu.
- Previous trials demonstrated the vaccine induced a stronger immune response against all four influenza A and B strains.
- Plans include regulatory engagement to advance approval, leveraging the vaccine’s potential for rapid adaptation to future flu pandemics.
The severity of this past flu season underscores the need for more effective vaccines.— CEO Stéphane Bancel commented on the results of the study regarding the new vaccine.
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Key FactsModerna Combines Flu and COVID-19 Vaccines
May 7, 2025 · Reading time: ~45 sec.
Summary created with AI assistance · Source: apnews.com
Summary created with AI assistance · Source: apnews.com
- A new combination flu and COVID-19 vaccine showed stronger immune responses in individuals over 50 compared to existing standalone shots, according to a Moderna study.
- Side effects reported included injection site pain, fatigue, and headaches.
- The FDA is requesting additional data on the vaccine's effectiveness before granting approval.
- Experts express doubts about the popularity and effectiveness of the combination vaccine in managing seasonal flu outbreaks.
I agree in this case with FDA that efficacy data are important to see.— Dr. Greg Poland, a vaccine researcher at Mayo Clinic, comments on the importance of efficacy data for the new combo vaccine.
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