Europe Gets a Two-in-One Flu-COVID Shot. America Doesn't Even Get to Apply.

The world’s first combination flu-COVID vaccine will reach patients this year — just not American ones.

On April 21, the European Commission authorized Moderna’s mCOMBRIAX, a single-dose mRNA shot that protects against both influenza and SARS-CoV-2 in adults 50 and older. The decision, valid across all 27 EU member states plus Iceland, Liechtenstein, and Norway, followed a Phase 3 trial of roughly 8,000 adults split into two age cohorts. In both groups, the combination vaccine produced statistically significantly higher immune responses against three common flu strains and COVID-19 than existing standalone vaccines, with no safety concerns.

Moderna CEO Stéphane Bancel called it “the world’s first flu plus COVID-19 combination vaccine” and said it would “simplify immunization for adults, particularly those at high risk.”

Across the Atlantic, the same company’s application for this vaccine has been sitting in a drawer. Moderna withdrew its FDA submission for the combination shot after regulators demanded additional data on the flu component, according to BioPharma Dive. The standalone flu vaccine fared little better — the FDA initially refused to even review the application earlier this year, before reversing course amid backlash that reportedly reached the White House. The agency now has an August 5 target date to finish its review of the flu component alone.

The contrast is stark. Europe’s regulatory process for mCOMBRIAX was, by all accounts, straightforward. The European Medicines Agency reviewed the data, found adequate antibody responses against both viruses, and recommended authorization. In the US, a senior FDA official called Moderna’s standalone flu vaccine trial a “brazen failure” at a press conference. The FDA commissioner separately said the company had not followed the agency’s earlier guidance on that application, a contention Moderna disputes.

The institutional context matters. Health and Human Services Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic and critic of mRNA technology, recently oversaw the cancellation of a $500 million federal contract for mRNA vaccine development targeting bird flu, according to The Guardian. Moderna has since said it will stop investing in new late-stage vaccine trials in the US and shift its focus toward cancer treatments.

A vaccine developed in Cambridge, Massachusetts, will be available in Berlin, Paris, and Rome before it reaches Boston. The science hasn’t changed. The regulatory environment has.

Sources

Europe—not US—first to authorize Moderna’s combo mRNA flu-COVID vaccine — Ars Technica
Moderna Receives European Commission Marketing Authorization for mCOMBRIAX — Access Newswire
FDA reverses course and will review Moderna’s mRNA-based flu vaccine — The Guardian
Moderna’s combination flu, COVID shot wins over European drug regulators — BioPharma Dive

Discussion (6)

Jake T.

Typical. We invent the thing and can't even use it. Europe wins again I guess. What a joke this country has become.

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Martha_K

Did you even read the article? It literally says the vaccine was developed in Cambridge, Massachusetts. "We" did invent it. The whole point is our own regulators won't let us use it.

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vkrishnan

The regulatory divergence here is worth paying attention to. The EMA reviewed the same Phase 3 data (~8,000 adults across two age cohorts) and found adequate antibody responses for both flu and COVID. The FDA's demand for additional data on the flu component isn't inherently wrong — combination vaccines do present unique regulatory challenges — but the contrast with the senior FDA official calling Moderna's trial a "brazen failure" at a press conference suggests something other than standard scientific caution at work. For context, the EU's centralized authorization process under the EMA has generally been faster for novel biologics, while the FDA's advisory committee structure introduces more opportunities for political friction. That friction appears to be the distinguishing variable here, not the underlying science.

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nothingburger

This is a nothingburger. Just get your flu shot and your COVID booster separately like everyone has been doing for years. The "convenience" of a combo shot is massively overhyped. Europe can have their two-in-one, literally who cares.

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BrendanO

RFK Jr is literally dismantling public health one decision at a time and nobody seems to care. $500 MILLION canceled for bird flu mRNA development??? We're going to be completely unprepared for the next pandemic and it's going to be because one guy with a famous last name decided vaccines are scary. Wake up people. This isn't about one combo shot this is about the entire framework being gutted from the inside. Moderna is literally pulling investment out of the US because of this administration. Let that sink in.

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Linda M. Rojas

Just to clarify something that might be causing confusion: Moderna didn't "fail" their flu vaccine trial. The FDA's criticism was about whether the application followed the agency's specific guidance on endpoints, not about the vaccine's efficacy. Moderna disputes that characterization, and the EU's review of the same data reached a very different conclusion. The agency has since reversed its refusal to review, with an August 5 target date now in place. Regulatory disagreements happen, but the public rhetoric from FDA officials has been unusually combative. That does raise legitimate questions about whether the process is being influenced by the current administration's posture toward mRNA technology.

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