# mFLUSIVA (mRNA-1010) PDUFA Event: Influenza prevention

Canonical URL: https://biopharmsignal.com/pdufa-calendar/MRNA/mrna-1010-influenza

Ticker: MRNA

Company: Moderna, Inc.

Event date: 2026-08-05

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-08-05

Application type: BLA

FDA approved mFLUSIVA for adults aged 50 and older. FDA granted traditional approval for adults aged 50–64 and accelerated approval for adults aged 65 and ol...

## Event Timeline

### August 5, 2026 — FDA approved mFLUSIVA for adults aged 50 and older

FDA granted traditional approval for adults aged 50–64 and accelerated approval for adults aged 65 and older. mFLUSIVA became the first mRNA-based seasonal influenza vaccine approved in the United States; the accelerated-approval population is subject to confirmatory evidence requirements.

[Moderna — mFLUSIVA FDA approval announcement](https://investors.modernatx.com/news/news-details/2026/Moderna-Receives-U-S--FDA-Approval-for-Influenza-Vaccine-mFLUSIVA/default.aspx)

### June 18, 2026 — VRBPAC voted 9–0 in favor

The FDA advisory committee voted 9–0 that the benefits of mRNA-1010 outweigh its risks in adults aged 50–64 and separately voted 9–0 for adults aged 65 and older. The PDUFA goal date remained August 5, 2026.

[Moderna — VRBPAC vote and PDUFA update](https://moderna2022rd.q4web.com/news/news-details/2026/Moderna-Announces-FDA-Advisory-Committee-Votes-Unanimously-in-Favor-of-the-Benefit-Risk-Profile-of-mRNA-1010-an-Investigational-Seasonal-Influenza-Vaccine/default.aspx)

### May 6, 2026 — P304 results published in NEJM

The Phase 3 P304 trial showed 26.6% relative vaccine efficacy versus licensed standard-dose influenza vaccines in adults aged 50 years and older.

[NEJM — Efficacy and Safety of an mRNA Seasonal Influenza Vaccine in Adults](https://www.nejm.org/doi/full/10.1056/NEJMoa2516491)

### April 6, 2026 — Revaccination analysis announced for ESCMID 2026

Moderna reported that sequential administration produced no increase in solicited adverse reactions and identified no new safety concerns. The analysis was scheduled for presentation at ESCMID on April 18, 2026.

[Moderna — mRNA-1010 revaccination data at ESCMID 2026](https://moderna2022rd.q4web.com/news/news-details/2026/Moderna-to-Present-Revaccination-Data-for-Its-Investigational-Seasonal-Influenza-Vaccine-and-for-mRESVIA-at-ESCMID-2026/default.aspx)

### February 18, 2026 — FDA accepted the amended U.S. BLA for review

Following a Type A meeting and submission of an amended application, FDA accepted the mRNA-1010 BLA and assigned a PDUFA goal date of August 5, 2026. The application was also under review in Europe, Canada and Australia.

[SEC — Moderna 2025 Form 10-K](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000033/mrna-20251231.htm)

### January 5, 2026 — Marketing applications filed in four markets

Moderna announced submissions in the United States, European Union, Canada and Australia for adults aged 50 years and older.

[Moderna — Global regulatory submissions](https://moderna2022rd.q4web.com/news/news-details/2026/Moderna-Announces-Global-Regulatory-Submissions-for-Its-Investigational-Seasonal-Influenza-Vaccine/default.aspx)

### November 6, 2025 — Phase 3 conference presentations reported

Moderna reported that P304 efficacy and safety results had been presented at IDWeek 2025, with relative vaccine efficacy results in a high-risk subgroup presented at ESWI 2025.

[SEC — Moderna Q3 2025 Form 10-Q](https://www.sec.gov/Archives/edgar/data/1682852/000168285225000075/mrna-20250930.htm)

### June 30, 2025 — Positive Phase 3 P304 efficacy results announced

mRNA-1010 demonstrated 26.6% relative vaccine efficacy versus a licensed standard-dose comparator and met the protocol's most stringent prespecified superiority criterion.

[Moderna — Positive Phase 3 P304 results](https://investors.modernatx.com/news/news-details/2025/Moderna-Announces-Positive-Phase-3-Results-for-Seasonal-Influenza-Vaccine/default.aspx)

### September 16, 2024 — Phase 3 P304 study started

The randomized P304 efficacy study began enrolling adults aged 50 years and older to compare mRNA-1010 with licensed seasonal influenza vaccines.

[ClinicalTrials.gov — P304 study record (NCT06602024)](https://clinicaltrials.gov/study/NCT06602024)

### September 13, 2023 — P303 met all co-primary endpoints

In an interim Phase 3 analysis, the updated mRNA-1010 formulation met all co-primary endpoints across the four included influenza A and B strains.

[Moderna — P303 Phase 3 results](https://investors.modernatx.com/news/news-details/2023/Moderna-Expands-the-Field-of-mRNA-Medicine-with-Positive-Clinical-Results-Across-Cancer-Rare-Disease-and-Infectious-Disease/default.aspx)

## Regulatory Designations

- Priority Review FDA: [SEC — Moderna exercised a Priority Review Voucher](https://www.sec.gov/Archives/edgar/data/1682852/000168285226000012/exhibit991-02102026.htm)

## Related Pages

- MRNA PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/MRNA.md

- MRNA company profile: https://biopharmsignal.com/company/MRNA.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md