Europe just approved a combined flu and COVID shot. Why hasn’t the US?

On Friday, Moderna’s mCombriax—a combined vaccine for both the flu and COVID—was recommended for authorization by European regulators, which opens the door for the vaccine’s approval in the European Union. 

The European Medicines Agency, the regulator granting the recommendation (or adopting a “positive opinion” on recommending it for market authorization), said that the messenger RNA vaccine should help protect “people aged 50 years and older against COVID-19 and seasonal influenza (flu),” in a statement. 

The shot works like any other vaccine, effectively prepping the human body to defend itself against foreign infection, with the messenger RNA contained within giving blueprints to the body to make proteins to help stave off various seasonal flu viruses, and SARS-CoV-2. “As the first combined COVID-19/influenza vaccine, mCombriax provides people with the option of having a single shot to protect against both illnesses,” reads a statement from the Agency.

Next, the European Commission would need to ratify the recommendation to open it up for widespread use.

“The CHMP’s positive opinion represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine,” said Stéphane Bancel, Moderna’s CEO, in a statement. “Combination vaccines have the potential to simplify vaccination and support improved health outcomes. We appreciate the EMA’s rigorous scientific review.”

The big question remaining: What about the United States?

The answer is complicated and unclear, but part of it has to do with the Food and Drug Administration’s (FDA) higher standards and scrutiny. Moderna applied for clearance in the U.S. back in 2024, supplying data showing that the vaccine was effective against both the flu and COVID viruses. But the FDA had asked for more supplemental data, according to reporting from BioPharma Dive, prompting Moderna to withdraw the submission, gather more data, and then resubmit it.

Also, additional hurdles have entered the fray. The The President administration—which includes several high-profile anti-vaccine advocates in various leadership positions—initially opted not to review its application, though it changed its mind shortly thereafter after public and industry pressure. As it stands, that’s where the bottleneck is: With the FDA’s review process. It’s unclear if or when the vaccine could win approval or be made available to the public in the United States.

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