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health9h ago

FDA refuses to review Moderna’s mRNA flu vaccine application

https://www.foxnews.com/health/fda-refuses-review-modernas-mrna-flu-vaccine-applicationhttps://www.theguardian.com/us-news/2026/feb/10/fda-moderna-flu-vaccinehttps://www.cnn.com/2026/02/10/health/fda-moderna-mrna-flu-vaccine
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FDA refuses to review Moderna’s mRNA flu vaccine application Open in Foxnews.com
Highlights
  • The FDA did not find safety or efficacy issues, but objected to the trial comparator used to evaluate Moderna's shot.
  • Regulators say using a standard flu shot as comparator does not reflect the best-available standard of care, which may affect the review outcome.
  • Moderna argues it compared its vaccine to a high-dose shot for seniors, while regulators question its applicability across age groups.

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References

FDA declines to review Moderna application for new flu vaccine

https://www.theguardian.com/us-news/2026/feb/10/fda-moderna-flu-vaccineTheguardian.com
FDA declines to review Moderna application for new flu vaccine

FDA refuses to review Moderna’s application for mRNA flu vaccine, company says | CNN

https://www.cnn.com/2026/02/10/health/fda-moderna-mrna-flu-vaccineCnn.com
FDA refuses to review Moderna’s application for mRNA flu vaccine, company says | CNN

FDA declines to review Moderna's mRNA flu shot

https://www.nbcnews.com/health/health-news/fda-declines-review-modernas-mrna-flu-shot-rcna258436Nbcnews.com
FDA declines to review Moderna's mRNA flu shot

FDA refuses to review Moderna's mRNA flu vaccine

https://arstechnica.com/health/2026/02/fda-refuses-to-review-modernas-mrna-flu-vaccine/Arstechnica.com
FDA refuses to review Moderna's mRNA flu vaccine

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healthbusinessu.s. food and drug administration

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