The news: Moderna's mRNA flu vaccine won FDA approval after a delayed review process that included an initial refusal to review the application. The shot will be available for adults 50 + during the 2026-2027 flu season. The shot, called mFlusiva, reduced flu cases by 27% compared with a standard flu shot in clinical trials.

Why it matters: The approval comes despite the Trump administration's broader skepticism toward mRNA and flu vaccines. HHS Sec. Robert F. Kennedy Jr. has long questioned the safety and efficacy of mRNA and flu vaccines. Last year, he canceled $500 million in federal mRNA grants, eliminating flu, COVID-19, and infectious disease research using the technology. He also rescinded recommendations for flu vaccines containing thimerosal and ended the CDC’s annual promotional ad campaign encouraging flu shots.

Consumer perceptions of both mRNA and flu vaccines also remain a hurdle. Nearly one-quarter (24%) of US adults believe the misleading claim that mRNA probably or definitely can change your DNA, per a May KFF survey. The perceived safety of flu vaccines has declined to 80% of US adults in December 2025, down three percentage points from a year earlier, per a December Annenberg survey. At the same time, flu vaccinations are declining among adults and children, with 42% and 50% covered, respectively, in the 2024-2025 season, per the CDC in January 2026. That’s down 3% for adults and 5% for children YoY.

Implications for pharma companies: For Moderna and other mRNA drug developers, the approval door appears open, albeit narrowly. Companies with strong clinical data and disciplined regulatory execution can still win FDA approval despite increased political scrutiny.

But the FDA's decision shouldn't be read as a sign that federal mRNA funding will return. Drugmakers should expect to rely on private capital and partnerships, and expect product-by-product approvals for their mRNA programs. The approval also doesn’t guarantee adoption. To earn provider and consumer trust, companies will need to clearly demonstrate clinical value and invest in sustained, evidence-based education.

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