European Regulator Recommends Approving Moderna’s COVID-Flu Vaccine

Europe’s medical regulator on Feb. 27 recommended approval of Moderna’s COVID-19-influenza vaccine.

Data show the vaccine, known as mCombriax, “triggered the production of adequate amounts of antibodies against both viruses,” the European Medicines Agency said in a statement.

Moderna’s COVID-19 vaccine has been available in many countries since early in the COVID-19 pandemic. The company’s influenza and combination COVID-flu shots, which also utilize messenger ribonucleic acid (mRNA) technology, have not yet been cleared anywhere.

Experts with the European agency reviewed a study involving 8,000 people aged 50 and up. Participants who received the experimental combination shot had a non-inferior response to those who received Moderna’s COVID-19 vaccine in combination with an authorized flu vaccine.

A separate study of Moderna’s influenza shot found it can prevent influenza-like illness and provoke an immune response deemed adequate, the European Medicines Agency said.

The agency noted that the combination vaccine can cause side effects, including headache and chills.

The recommendation will be sent to the European Commission, which will consider whether to adopt it. If the commission does, then each member state will decide how to price the vaccine and reimburse for its administration.

Stéphane Bancel, Moderna’s CEO, said the recommendation “represents an important milestone for respiratory virus vaccination and for Moderna, with the introduction of the world’s first flu plus COVID combination vaccine.”

He said that combination shots “have the potential to simplify vaccination and support improved health outcomes.”

Moderna in 2025 rescinded its application for the COVID-flu shot in the United States, based on discussions with the U.S. Food and Drug Administration. It said later in the year that there were positive efficacy results in a trial, and that the results would lead to resubmission.

“We were holding back on refiling the combo vaccine until we completed some portion of the review of the flu vaccine,” Dr. Stephen Hoge, Moderna’s president, told investors in a call on Feb. 13.

The FDA recently told Moderna that it would not consider a separate application for the experimental flu vaccine because the company did not use the proper comparator vaccine in testing. On Feb. 18, the FDA said that it agreed to accept an amended application that included a promise to conduct a trial after approval, if the product is approved.

Pfizer and BioNTech, which also have an mRNA vaccine on the market, are developing a combination COVID-flu shot but trial results have been mixed. The companies have not yet asked regulators for approval for their combination vaccine.