This week, the Food and Drug Administration (FDA) approved Moderna’s MFlusiva vaccine after a contentious approval process. MFlusiva is the first seasonal influenza vaccine approved in the United States to use messenger RNA, or mRNA, technology, which became widely known through the COVID-19 vaccines. The FDA approved the vaccine for adults 50 and older, potentially opening the door to faster and more adaptable flu vaccines in the future.

In February, the FDA initially refused to review Moderna’s application. The agency objected to Moderna’s decision to compare its experimental vaccine with a standard-dose influenza vaccine rather than one of the enhanced vaccines generally preferred for older adults. Moderna protested that it had previously discussed its trial design with regulators. The FDA subsequently reversed course and agreed to consider a revised application.

FDA approval of Moderna’s mRNA vaccine could open the door for similar medications in the U.S., while potentially speeding up the process of vaccine development. Most conventional influenza vaccines take months to develop because they require viruses or viral proteins to be produced through eggs or other biological manufacturing systems…

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An mRNA vaccine can be produced much faster because it gives cells genetic instructions for producing influenza antigens that teach the immune system what to recognize. Manufacturing can begin later and proceed faster, giving scientists more time to identify the strains circulating.

Evidence presented during the review process persuaded regulators to approve it. Overall safety information included data from more than 71,000 participants. The principal efficacy trial found that mFlusiva produced a 26.6 percent higher relative vaccine efficacy than a licensed standard-dose flu vaccine. That means recipients had about a 27 percent lower risk of developing influenza compared with recipients of the conventional vaccine.

The FDA also sought outside advice. All nine members of its vaccine advisory committee voted that mFlusiva’s benefits outweighed its risks for both age groups. Committee members also noted that establishing an mRNA influenza vaccine could improve preparedness for future flu strains and pandemics.

During the severe 2024-2025 flu season, the Center for Disease Control estimated that influenza caused 51 million illnesses, 710,000 hospitalizations and 45,000 deaths in the United States. Vaccination prevented an estimated 180,000 hospitalizations and 12,000 deaths. People 65 and older accounted for 71 percent of flu deaths.

Messenger-RNA vaccines give cells a temporary genetic blueprint to make a harmless piece of a virus, like the spike protein viruses use to gain entrance to human cells. A person’s immune system recognizes the spike protein as a threat, builds antibodies, and destroys the mRNA within days, leaving your body prepared to fight the real virus in the future.

Many mRNA vaccines, including the COVID-19 vaccine, are out of the body within 72 hours, but they leave the immune system with a lasting ability to fight viruses.

Public trust in health care has reached dangerous lows in the United States, and the results have been both predictable and unfortunate. In 2026, measles cases hit a fifty year high in the U.S., and an ongoing cyclospora outbreak has now become the worst outbreak of that organism in American history. When trust in health care declines, behavior changes, and preventative measures that could have helped prevent public health crises go unused.

The approval of a new flu vaccine could represent a first step in rebuilding public confidence in health care by delivering a more effective way to manage flu infections.

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