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Moderna pulls application for COVID-flu combination shot
- Moderna voluntarily withdrew its FDA application for a COVID-19 and influenza combination vaccine for adults aged 50 and older on May 21, 2025.
- The withdrawal followed FDA requests for additional Phase III influenza vaccine efficacy data and tightened clinical trial requirements for COVID boosters in healthy adults under 65.
- Moderna plans to resubmit the application later in 2025 after collecting interim data from an ongoing Phase III trial of its standalone seasonal influenza vaccine, mRNA-1010.
- A Phase III trial showed the combination vaccine met its primary endpoint of noninferiority and produced higher immune responses against influenza strains and SARS-CoV-2 variant Omicron XBB.1.5.
- This withdrawal signals a delayed approval timeline to 2026 and highlights the impact of stricter FDA standards amid declining COVID vaccine sales and challenging market conditions for Moderna.
33 Articles
33 Articles
Moderna withdraws approval of its combined vaccine – the share is falling. The Group is already working on the next mRNA vaccine project.
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Moderna pulls application for COVID-flu combination shot
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot, which is due later this year.
Vaccine Manufacturer Pulls Application For New mRNA Jab
Moderna has withdrawn its application seeking approval for a flu and COVID-19 combination jab. “Moderna, Inc., today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older,” the company said. “The Company plans to resubmit the BLA later this y…
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