FDA approves mFlusiva as first mRNA seasonal influenza vaccine for adults aged 50 years and older

The approval introduces the first messenger RNA influenza vaccine into the US market, expanding vaccine technology options for seasonal influenza prevention in older adults.

The US Food and Drug Administration (FDA) has approved mFlusiva (mRNA-1010), Moderna's seasonal influenza vaccine, for the prevention of influenza in adults aged 50 years and older, making it the first mRNA-based influenza vaccine approved in the United States.

The approval expands the use of mRNA technology beyond COVID-19 and respiratory syncytial virus vaccines, although commercial availability for the 2026–2027 influenza season will depend on existing supply contracts and distribution timelines.

Field	Content
Alert Type	Drug Approval
Drug Name	mFlusiva (mRNA-1010)
Indication	Active immunisation for the prevention of influenza in adults aged 50 years and older. (The Wall Street Journal)
Therapy Area(s)	Infectious Diseases; Vaccines
Geography	United States (FDA)
What Happened	On 5 August 2026, the FDA approved mFlusiva (mRNA-1010) for the prevention of seasonal influenza in adults aged 50 years and older. The decision makes mFlusiva the first mRNA-based influenza vaccine licensed in the United States following a positive recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee. The approval follows additional regulatory review after Moderna amended its application in response to earlier FDA concerns regarding trial design. (The Wall Street Journal)
Why It Matters	The approval introduces mRNA technology to seasonal influenza vaccination, providing an alternative manufacturing platform that could support future vaccine development and updates. It also represents an important regulatory milestone for Moderna as the company broadens its respiratory vaccine portfolio beyond COVID-19 and RSV, although real-world uptake will depend on procurement, reimbursement and clinician adoption. (Barron's)
Supporting Context	In a Phase III study involving more than 40,000 adults aged 50 years and older, mFlusiva demonstrated approximately 26.6% greater efficacy against influenza than a standard-dose comparator vaccine and reduced severe influenza requiring hospitalisation or urgent care by 47.9%. A post-marketing study in older adults is planned as part of the approval. (The Wall Street Journal)
Key Takeaway	FDA approval establishes mFlusiva as the first licensed mRNA seasonal influenza vaccine in the United States, expanding vaccine technology options for older adults.
What to Watch	Commercial rollout during the 2026–2027 influenza season, completion of the required post-marketing study and continued development of Moderna's combined influenza/COVID-19 vaccine programme. (Barron's)
Primary Source	https://www.fda.gov/news-events (FDA approval announcement); https://investors.modernatx.com (Moderna press release)
Relevant Date	5 August 2026

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