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yesterday

Moderna Withdraws Flu-COVID Vaccine Application After FDA Requests More Data

The company plans to resubmit its application later this year following interim results from its Phase 3 flu vaccine trial, expected this summer.

Moderna's decision comes a day after the U.S. Food and Drug Administration said it would require new clinical trials for approval of annual COVID-19 boosters for healthy people under 65.
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Overview

  • Moderna has voluntarily withdrawn its Biologics License Application for mRNA-1083, a flu and COVID-19 combination vaccine for adults aged 50 and older, after FDA feedback.
  • The FDA requested additional Phase 3 influenza efficacy data to support the application, prompting the delay.
  • Interim results from Moderna's ongoing Phase 3 trial of its standalone flu vaccine, mRNA-1010, are anticipated this summer and will inform the resubmission.
  • Moderna expects to resubmit the application later this year, with approval for the combination vaccine now targeted for 2026.
  • An FDA decision on Moderna’s next-generation standalone COVID-19 vaccine is still expected by the end of May 2025.