For five years, the industry has been asking what comes after COVID for mRNA.

The FDA approval of Moderna’s mFlusiva takes the technology into a much tougher commercial setting: seasonal influenza. It is the first mRNA flu vaccine licensed in the US, entering a crowded market shaped by established suppliers, annual purchasing cycles and vaccine recommendations.

Approval gives Moderna an mRNA product in another major vaccine category. What it does not yet show is whether the technology can support a durable franchise.

That depends partly on whether the development, manufacturing and regulatory experience built around one product reduces the time, cost or risk of bringing the next product to market.

Visiongain Top Takeaways

• Flu is mRNA’s next commercial test: Moderna now has to take share from established suppliers.
• The platform case depends on reuse: Each new programme needs to benefit from what came before.
• Oncology changes the economics: Personalised vaccines offer greater value per patient, but bring far more complexity.
• Manufacturing may decide who scales: Capacity, speed and specialist capability could become the bottleneck.

Flu puts mRNA into a crowded market

Moderna is entering a seasonal flu market where Sanofi, GSK and CSL Seqirus already have established products and manufacturing networks. CSL Seqirus describes itself as one of the world’s largest influenza vaccine providers, while GSK and Sanofi continue to supply and develop their own flu portfolios.

mFlusiva has a clear potential advantage. mRNA can be manufactured faster than conventional flu vaccines, potentially allowing strain selection closer to the season and improving the match with circulating viruses.

There is clinical differentiation too. In the pivotal study, mFlusiva showed 26.1% relative vaccine efficacy in adults aged 50–64 compared with a standard-dose flu vaccine. Reactions such as injection-site pain and fatigue were more common, although they were predominantly mild to moderate and short-lived.

The tougher market is older adults. The FDA granted traditional approval for those aged 50–64 but accelerated approval for people aged 65 and over. Moderna must now confirm clinical benefit in the older group against a vaccine preferentially recommended for that population.

The approval itself followed an unusual route. The FDA initially refused to file Moderna’s application in February over the comparator used in older adults, before reversing course two weeks later. Its vaccine advisory committee subsequently voted unanimously in favour of mFlusiva’s benefit-risk profile.

Approval gets Moderna into the market. It does not tell us how much share mRNA can take.

The real test is whether those advantages are enough to change recommendations and buying decisions.

A platform has to deliver more than another product

The appeal of mRNA has always been that companies should be able to build on what they have already learned. Sequence design, formulation, manufacturing know-how and regulatory experience do not need to be rebuilt from scratch for every programme.

That only matters, though, if it improves the economics.

Visiongain forecasts the global mRNA vaccines market to grow from US$9.67bn in 2026 to US$34.71bn by 2036, a CAGR of 13.6%.

A string of successful standalone vaccines would still create a sizeable opportunity. The bigger prize is a portfolio in which earlier investment cuts the cost, time or risk of developing later candidates.

Moderna’s RSV launch showed why execution still matters. mRESVIA reached the market after many customers had already made their seasonal purchasing decisions, contributing to a slower start than expected.

Flu gives Moderna another chance to show whether the benefits of mRNA carry from one franchise to the next.

Respiratory vaccines are where the portfolio takes shape

Flu is only one part of Moderna’s respiratory strategy.

The company already has mRNA products for COVID-19 and RSV, while mCOMBRIAX combines COVID-19 and influenza in a single vaccine for people aged 50 and over. The combination received EU marketing authorisation in April 2026.

A respiratory franchise spanning COVID, flu and RSV would allow greater use of the same development and production capabilities.

Combination vaccines could be where mRNA offers a clearer reason to switch. A single shot covering flu and COVID could simplify seasonal vaccination, but convenience alone will not create demand.

Any combination will still have to give healthcare systems and patients enough reason to switch.

The respiratory portfolio is the clearest opportunity yet to see whether mRNA can support a durable vaccine franchise rather than a series of standalone products.

Oncology pushes the model much further

Visiongain estimates the global mRNA cancer vaccine market at US$1.29bn in 2026, rising to US$14.12bn by 2036, a CAGR of 27.1%.

Moderna and Merck are already pushing mRNA into treatment with intismeran autogene, formerly V940 or mRNA-4157, in combination with Keytruda. Five-year follow-up from the Phase IIb KEYNOTE-942 study showed a 49% reduction in the risk of recurrence or death versus Keytruda alone in high-risk melanoma. Phase III development is under way.

Personalised cancer vaccines are a very different proposition from seasonal flu.

Each treatment begins by sequencing a patient’s tumour to identify mutations and select relevant neoantigens. A bespoke vaccine then has to be produced within the patient’s treatment timeline.

Manufacturing has to work reliably at small scale, while reimbursement will depend on whether the clinical benefit supports the additional cost and complexity.

The underlying mRNA technology may be shared, but much of the workflow and commercial model becomes patient-specific.

Manufacturing exposes the limits of reuse

Visiongain forecasts the vaccine contract manufacturing market to grow from US$3.95bn in 2026 to US$11.07bn by 2036, at a CAGR of 10.9%.

Seasonal vaccines need dependable output at volume. Personalised cancer vaccines require much smaller batches produced quickly enough to fit an individual treatment schedule.

Some capabilities can be shared, including mRNA production, lipid nanoparticle formulation, analytical testing and fill-finish. But not every process transfers neatly between products.

That opens opportunities for specialist manufacturing partners. Lonza, for example, offers integrated mRNA and LNP development, encapsulation and fill-finish services, while Thermo Fisher Scientific supports mRNA production workflows spanning LNP encapsulation, formulation and final fill.

Where new equipment, process development or specialist capacity is still required, the savings from a common technology base begin to narrow.

That makes the manufacturing question quite practical: how much of the infrastructure can genuinely be shared before each new product starts requiring its own production solution?

Visiongain Insight

mFlusiva gives Moderna another approved product, but the commercial picture will take longer to emerge.

Flu matters because it puts mRNA into an established market where Moderna has to compete for recommendations, contracts and repeat demand, rather than rely on the exceptional conditions that shaped the COVID vaccine market.

The next few seasons should give a clearer indication of whether that can become a durable respiratory business.

Scientific flexibility has taken mRNA this far. Commercial execution now has to do the rest.

See where vaccine growth is moving next in Visiongain’s free report, The New Vaccine Growth Model.

From Visiongain: Vaccines Intelligence Hub

Vaccine markets are being reshaped by new platforms, shifting policy, changing demand and growing pressure on manufacturing and delivery.

Visiongain’s Vaccines Intelligence Hub brings together briefings, analysis and market insight on the forces shaping the sector, from mRNA and cancer vaccines to manufacturing, next-generation delivery, procurement and commercial strategy.

Explore the Vaccines Intelligence Hub for strategic updates and related market reports.

Related reports include:

• Vaccine Sales Market Report 2026–2036
• mRNA Vaccines Market Report 2026–2036
• mRNA Cancer Vaccine Market Report 2026–2036
• Vaccine Contract Manufacturing Market Report 2026–2036

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