European regulators on April 21 cleared a combination vaccine made by Moderna that targets COVID-19 and influenza.
Moderna’s messenger ribonucleic acid (mRNA) vaccine, mCombriax, is the first authorized combination flu–COVID shot after receiving clearance from the European Commission for individuals aged 50 and older.
“By combining protection against two significant respiratory viruses in a single dose, our vaccine aims to simplify immunization for adults, particularly those at high risk,” Stéphane Bancel, Moderna’s CEO, said in a statement.
He said the vaccine “offers an important new option for Europeans.”
The company expects the product to become available to the public soon.
The European Commission’s action came after the European Medicines Agency in February recommended approval of mCombriax, based on testing that triggered a non-inferior immune response in people who received the shot compared with people who received an already-authorized flu vaccine and a shot of Moderna’s stand-alone COVID-19 vaccine, which also uses mRNA technology.
The data showed that the vaccine “triggered the production of adequate amounts of antibodies against both viruses,” the agency stated at the time.
The commission’s authorization covers the 27 member states of the European Union, Iceland, Liechtenstein, and Norway.
It sets the stage for each member state to decide whether to roll out the combination vaccine and, if so, how much it will cost.
The mRNA in vaccines uses part of the disease the shots target to teach the body to recognize and protect against the disease.
Moderna’s mRNA shot against COVID-19 was first authorized in 2020, during the COVID-19 pandemic. It has since developed and had cleared another COVID-19 vaccine and an mRNA respiratory syncytial virus shot.
Proponents say the vaccines protect well and have a solid safety profile. Detractors, including U.S. Health Secretary Robert F. Kennedy Jr., have expressed concern about the waning immunity from the vaccines and the side effects they can cause, such as heart inflammation.
Moderna in 2025 withdrew its application for mCombriax after talking with U.S. regulators under Kennedy’s oversight. The regulators said in 2026, in response to an application for Moderna’s stand-alone flu vaccine, that Moderna did not use the proper comparator flu vaccine in its trial for the shot. The U.S. Food and Drug Administration, however, later agreed to review the vaccine.
A spokesperson for Moderna did not immediately return a request for comment on whether the European Commission’s authorization of the combination vaccine would prompt a new application for the shot in the United States.