Announcement • Aug 28

Moderna Receives Fda Approval for Mflusiva, the First Mrna Influenza Vaccine for Adults 50 and Older

Moderna's mFlusiva, the first influenza vaccine to use mRNA technology, was approved by the U.S. Food and Drug Administration for adults 50 and older. Tens of thousands of Americans typically die from the flu every year, and the vast majority of them are 65 and older. The approval gives many older Americans a long-awaited new option for protection. It has long been a public health priority to evolve flu vaccine technology—a process which currently takes more than six months to produce a shot and is prone to mismatches with the circulating strains—so that manufacturers can respond more quickly to the evolving virus, ultimately making flu shots more effective. Regulators in the EU, Canada, and Australia are also reviewing the vaccine, and the European Medicine Agency has separately authorized a combined mRNA COVID-flu vaccine, also by Moderna. The FDA's committee of outside scientists, which reviews data on vaccine safety, effectiveness, and appropriate use, voted unanimously that mFlusiva's benefits outweigh its risks for adults 50 and older. In clinical trials, mFlusiva (mRNA-1010) was about 26.6% more effective at preventing laboratory-confirmed influenza illness than a traditional flu vaccine. It also produced a stronger immune response than traditional vaccines in adults 65 and older, with similar rates of severe side effects—which remained rare. That promising data led to accelerated FDA approval that expedites access to the shot for that high-risk group. The vaccine's safety has been tested in roughly 70,000 people in clinical trials. The 2026-27 flu season will provide the first real-world data on how the vaccine performs in populations that don't typically meet criteria for clinical trials, such as organ transplant recipients, severely immunocompromised people, or people on certain medications. Existing data from mRNA COVID vaccines bodes well for mFlusiva's real-world safety profile. The standard inactivated vaccine—used in most flu shots—is grown from flu viruses in eggs, a technology that's been in use for 80 years. The virus is grown, then killed, then made into a vaccine—a process that takes months, meaning scientists must predict as early as January or February which strain will be circulating in the fall, more than six months later. The other traditional platform is recombinant/subunit protein vaccines, which contain pieces of the flu pathogen that company immune systems learn to recognize and defend against. This method can produce vaccines faster than the egg-based process but is more expensive. Rather than growing a virus or isolating proteins, mRNA vaccines deliver a short genetic script that instructs the body's own cells to produce a piece of the flu virus, training the immune system to recognize it. Because that script can be rewritten and swapped out quickly—without growing anything in eggs or cell culture—it is the fastest process, biologically, for updating a vaccine. The speediness—how fast one can make an mRNA vaccine—is really helpful for things like flu and COVID, where the virus changes over time. This technology lends itself to being able to move more quickly and pivot to give a vaccine that may be a better match for the upcoming flu season. If one has a vaccine that one can start making in August and have it ready for September, it can be a better match for the strain that's actually circulating. The U.S. and many other countries have the infrastructure to quickly produce and adapt mRNA flu shots as needed, thanks to rapid vaccine development in response to the COVID pandemic. The new shot will be an option for many older adults this year—but it's unclear how widely available it will be or how many Americans will choose it. FDA approval typically means that health insurance will cover the vaccine, but it may not be stocked in every pharmacy. Traditional flu shots—already formulated for this season—will remain widely available. It's also unclear how much of the vaccine Moderna will manufacture and what price it will set. Uptake is another open question. Moderna may opt for a relatively small initial rollout to gauge interest and to run more studies comparing the vaccine's effectiveness against traditional flu shots. Other flu shots aren't going anywhere this season. They will still be an option for older Americans, and it could be years before mRNA shots are approved for younger Americans—a process that requires separate clinical trials. Longer term, the effectiveness in real-world, post-licensure data could shape what happens to older vaccine development processes. Typically, the CDC's Advisory Committee on Immunization Practices compares available vaccines, and if one is clearly more effective with no added safety concerns, it becomes the recommended option. In 2018, Shingrix became the CDC's recommended shingles vaccine after it proved significantly more effective than its predecessor, Zostavax, which was later discontinued and pulled from the U.S. market in 2020. Something similar could eventually happen with flu vaccines, but resistance to mRNA technology could complicate that decision.

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