The FDA reversed its refusal to review Moderna’s mRNA flu vaccine application and accepted a revised filing with split age cohorts and a post-market study for adults over 65. The reversal came amid broader vaccine regulatory uncertainty and industry concern about unpredictable review timelines.
The FDA reversed course and said it would review Moderna’s application for a new mRNA-based flu vaccine. The move followed growing concern about federal vaccine policy and came after HHS canceled nearly $500 million in mRNA vaccine contracts.
Four biotech companies went public in one week raising nearly $1 billion, signaling a potential thaw in IPO markets after years of quiet activity. Regional life sciences hubs outside Boston and San Francisco are attracting record venture funding, while regulatory uncertainty at FDA continues to concern industry leaders.
The FDA has reversed its earlier refusal and will now review Moderna's mRNA-1010 seasonal influenza vaccine application, setting an August 5, 2026 review deadline after the company proposed a revised regulatory approach based on age groups.
Moderna announced the FDA will consider approving its mRNA-based flu vaccine for older adults after resolving a dispute over clinical trial design. The vaccine showed 34.5% higher efficacy than standard flu shots in trials.
The FDA agreed to review Moderna's mRNA flu vaccine after initially refusing the application, while separately announcing it will drop its longtime requirement for two clinical studies to approve new drugs.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
The FDA reversed its initial refusal and will now review Moderna's mRNA-based flu vaccine application, seeking full approval for adults 50-64 and accelerated approval for those 65 and older, with a decision targeted for August 5, 2026.
The FDA mandated febrile seizure warnings for flu vaccines and rejected Moderna's mRNA flu vaccine application, with a political appointee overruling agency staff despite no safety concerns identified.
