{"id":9725,"date":"2026-08-14T10:06:20","date_gmt":"2026-08-14T10:06:20","guid":{"rendered":"https:\/\/relocationtimess.com\/?p=9725"},"modified":"2026-08-14T10:06:20","modified_gmt":"2026-08-14T10:06:20","slug":"the-fda-approved-the-first-mrna-flu-vaccine-for-use-in-older-adults-heres-what-to-know","status":"publish","type":"post","link":"https:\/\/relocationtimess.com\/?p=9725","title":{"rendered":"The FDA approved the first mRNA flu vaccine for use in older adults. Here\u2019s what to know"},"content":{"rendered":"
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\n For older adults, the flu vaccine could look a little different this year.\n <\/p>\n

\n Last week, the US Food and Drug Administration approved the nation\u2019s first mRNA-based flu vaccine for use in people 50 and older. The vaccine, developed by Moderna, builds off the mRNA technology used in many Covid-19 vaccines.\n <\/p>

Read more Trump\u2019s overhaul of the federal workforce isn\u2019t quite over<\/a><\/p>\n

\n This first-of-its-kind mRNA flu vaccine has faced a bumpy road to approval amid a political climate not friendly to the technology: The Trump administration has cut funding for mRNA vaccine development, and the FDA initially declined Moderna\u2019s request to review the vaccine. But the agency\u2019s independent vaccine advisers unanimously voted in June that the new vaccine\u2019s benefits outweigh its risks.\n <\/p>\n

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\nModerna met with FDA officials after the agency initially rejected its application for a new mRNA flu vaccine.<\/span>\n<\/div>\n
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\nFDA reverses course and will review Moderna\u2019s mRNA flu shot, company says<\/span>\n<\/p>\n

2 min read<\/div>\n<\/div>\n<\/section>\n<\/div>\n

\n \u201cThe Food and Drug Administration\u2019s approval of a new mRNA flu vaccine is welcome news and provides another important option to help protect people from a virus that sends hundreds of thousands of Americans to the hospital each year and claims thousands of lives,\u201d Dr. Ronald G. Nahass, president of the Infectious Diseases Society of America, said in a statement.\n <\/p>\n

\n Here\u2019s what you need to know about the vaccine, called mFlusiva, which is set to be available this fall.\n <\/p>\n

\n How the mRNA flu vaccine is different\n<\/h2>\n

\n Traditional flu shots use inactivated or weakened forms or pieces of the virus to train the immune system to recognize the live virus if it enters the body.\n <\/p>\n

\n But mRNA vaccines use a piece of mRNA, or messenger ribonucleic acid, that encodes for a viral protein.\n <\/p>\n

\n When you receive an mRNA vaccine, your body gets the instructions to make a copy of that viral protein, which then generates the immune response that prepares you to fight off future infections.\n <\/p>\n

\n Influenza is a virus that is constantly mutating. Each year, scientists aim to match the strains in the vaccine to the ones most likely to be dominant in the coming flu season.\n <\/p>\n

\n \u201cSometimes there\u2019s a mismatch between what was selected, despite best efforts, and what the dominant circulating strain is,\u201d said Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University Medical Center. How closely matched the flu vaccine is to the dominant strain of the season is part of what accounts for the year-to-year changes in the shot\u2019s effectiveness.\n <\/p>\n

\n One limit to the currently used flu vaccine platform is that the selection of what virus strain to include must happen around February, about six months before the shots are administered. Currently, flu vaccines are manufactured by growing the influenza virus in cells or chicken eggs.\n <\/p>\n

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\nThe US keeps millions of chickens in secret farms to make flu vaccines. But their eggs won\u2019t work for coronavirus<\/span>\n<\/p>\n

6 min read<\/div>\n<\/div>\n<\/section>\n<\/div>\n

\n \u201cThat\u2019s a huge challenge because it is often limiting in terms of how fast and how much vaccine we can make,\u201d said Dr. Michael Osterholm, who directs the Center for Infectious Disease Research and Policy at the University of Minnesota.\n <\/p>\n

\n Since mRNA vaccines can be manufactured quickly, the strain selection can occur closer to when shots are administered \u2014 in May, instead of February.\n <\/p>\n

\n \u201cThis affords us a lot more flexibility in trying to match up the right strain of virus circulating with what\u2019s in the vaccine,\u201d Osterholm explained.\n <\/p>\n

\n Who can get the vaccine\n<\/h2>\n

\n The vaccine will be available for people 50 and older, but it got two different types of approval.\n <\/p>\n

\n Moderna\u2019s new vaccine was granted standard approval for adults 50 to 64 years old. For adults 65 and older, it received accelerated approval, a pathway negotiated after an unusual amount of back and forth with the FDA.\n <\/p>\n

\n The FDA had originally greenlit Moderna\u2019s study design for the mRNA flu vaccine but then rejected the application in February before eventually agreeing on the two-pronged approval pathway.\n <\/p>\n

\n The agency said this year that Moderna\u2019s application didn\u2019t contain an \u201cadequate and well-controlled\u201d trial because the control arm of the study didn\u2019t reflect the \u201cbest-available standard of care in the United States at the time of the study.\u201d\n <\/p>\n

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\nThe Moderna Inc. facility in Laval, Quebec, Canada, on September 19, 2025.<\/span>\n<\/div>\n
Graham Hughes\/Bloomberg\/Getty Images<\/figcaption>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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\nFDA refuses to review Moderna\u2019s application for mRNA flu vaccine, company says<\/span>\n<\/p>\n

6 min read<\/div>\n<\/div>\n<\/section>\n<\/div>\n

\n Moderna had compared the vaccine\u2019s efficacy in adults over 50 to a standard dose flu vaccine. However, guidance from the US Centers for Disease Control and Prevention recommends an enhanced dose vaccine for adults 65 and older.\n <\/p>\n

\n \u201cPeople over the age of 65, you don\u2019t want to compare it against a weaker vaccine,\u201d said Dr. Gregory Poland, director of research for the Atria Research and Global Health Institute in New York, who was not involved in study on Moderna\u2019s vaccine. \u201cYou want to compare it against one of the three vaccines that are preferentially used in older people.\u201d\n <\/p>\n

\n In the 65-and-older population, Moderna presented data showing that the vaccine has better ability to produce antibodies \u2014 the molecules in your body that help it recognize pathogens and fight illness \u2014 compared with an enhanced vaccine. The FDA granted accelerated approval under the condition that Moderna conduct a post-marketing study this coming flu season to ensure that that advantage in antibody production translates to a clinical advantage.\n <\/p>\n

\n \u201cI think the accelerated approval, with the obligation of the company to do some studies and to come back to the FDA with further data regarding effectiveness and safety, are entirely appropriate,\u201d Schaffner said. \u201cThat\u2019s been done for other vaccines, and that\u2019s a program that works out well.\u201d\n <\/p>\n

\n How to weigh which shot to get\n<\/h2>\n

\n Moderna\u2019s new vaccine was found to be about 27% more effective during the 2024-25 vaccine season than standard flu shots in the company\u2019s study, which enrolled over 40,000 people older than 50.\n <\/p>

Read more Trump wants to split the MMR vaccine into separate shots. Experts say it\u2019s a bad idea<\/a><\/p>\n

\n The mRNA vaccine did show higher rates of adverse reactions compared with the standard dose vaccine. But most of those reactions \u2014 injection site pain, muscle and joint pain, nausea and vomiting, fever, headache and chills \u2014 were mild to moderate and went away within days. Serious adverse events occurred at similar low rates in study participants who received the mRNA vaccine and the standard flu vaccines, and most were assessed to be unrelated to vaccination.\n <\/p>\n

\n People who have an allergy to any of the ingredients or who\u2019ve had Guillain-Barr\u00e9 syndrome after flu vaccination in the past should not get the new vaccine.\n <\/p>\n

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\nModerna has said it aims to have the mRNA vaccine available this fall, but it may be hard to find this season.<\/span>\n<\/div>\n
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\n Several experts said the new flu shot is a major step forward, and some emphasized the importance of the additional study Moderna will conduct this fall in adults older than 65 to compare mFlusiva\u2019s clinical benefit against an enhanced flu vaccine already recommended for older people.\n <\/p>\n

\n \u201cThe way I would summarize it is, in the 50- to 64-year-olds: good option, moderately compelling, better efficacy trade-off is about double the rate of side effects,\u201d Poland said. But in those 65 and above, \u201cwe need what\u2019s called real world effectiveness data and efficacy data.\u201d\n <\/p>\n

\n Dr. Sean Leng \u2014 a practicing geriatrician and professor of medicine at the Johns Hopkins University School of Medicine, where he directs the Center on Aging & Immune Remodeling \u2014 said that making the decision of whether to get a flu shot with his older patients is generally a simple conversation, as many of them are used to the yearly shot.\n <\/p>\n

\n \u201cIn my view, I would need to present those options for them,\u201d Leng said.\n <\/p>\n

\n If Moderna finds better clinical efficacy against the enhanced vaccines, he said, \u201cI would probably make a stronger recommendation to our patients.\u201d\n <\/p>\n

\n When the vaccine will be available\n<\/h2>\n

\n Moderna has said it aims to have the mRNA vaccine available this fall.\n <\/p>\n

\n Typically, after a new vaccine is approved, the US Centers for Disease Control and Prevention\u2019s Advisory Committee on Immunization Practices will review data and weigh in on whether the agency should recommend it. However, a federal judge ruled in March that US Health and Human Services Secretary Robert F. Kennedy Jr. did not follow federal legal procedures when he replaced all the committee\u2019s members, and it hasn\u2019t met since. A meeting is currently scheduled for October.\n <\/p>\n

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\nMembers of the CDC Advisory Committee on Immunization Practices (ACIP) are seen during a meeting on December 5, 2025 in Atlanta, Georgia.<\/span>\n<\/div>\n
Elijah Nouvelage\/Getty Images<\/figcaption>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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\nFederal vaccine panel in disarray after judge blocks changes<\/span>\n<\/p>\n

4 min read<\/div>\n<\/div>\n<\/section>\n<\/div>\n

\n Where the vaccine could be available\n<\/h2>\n

\n Because most pharmacies and clinics order their flu vaccines earlier in the year, mFlusiva\u2019s impact may be somewhat limited this coming season.\n <\/p>\n

\n \u201cWe\u2019re unsure at the moment what additional ordering levels will look like as far as pharmacies ordering and then stocking the new mRNA flu product,\u201d said Dr. Brigid Groves, vice president of professional affairs at the American Pharmacists Association.\n <\/p>\n

\n Dr. Michelle Fiscus, chief medical officer for the Association of Immunization Managers, said it may be easier for patients to find at larger pharmacies like CVS and Walgreens.\n <\/p>\n

\n \u201cI imagine there will be some demand for this vaccine \u2026 and that may mean that there\u2019s some limited availability,\u201d Fiscus said.\n <\/p>\n

\n Insurance coverage for the new vaccine\n<\/h2>\n

\n In the absence of a recommendation from the CDC\u2019s vaccine advisers, there also remains uncertainty around whether Moderna\u2019s mRNA flu vaccine will be covered by insurance.\n <\/p>\n

\n \u201cWithin the Affordable Care Act, it does specify what vaccines are considered covered,\u201d Groves said. \u201cThe confusion point lies in the fact that the ACIP, within the CDC, has not had an opportunity to convene and as such, has not had a chance to review the new flu mRNA vaccine and\/or issue a recommendation or guidelines around it.\u201d\n <\/p>\n

\n Flu vaccines are usually covered at zero copay by Medicaid and Medicare, as well as commercial insurance plans, but Groves said that \u201cat this point, it\u2019s unclear as to what coverage will look like.\u201d\n <\/p>\n

\n Moderna, HHS and the CDC did not respond to a request for comment on plans for rolling out the vaccine.\n <\/p>\n

\n Why it\u2019s important for older people to get a flu shot\n<\/h2>\n

\n Flu vaccines are especially important for older adults who are at a much higher risk of complications, hospitalization and death from influenza.\n <\/p>\n

\n According to CDC data from the 2024-25 flu season, 76.9% of hospitalizations from flu were in adults older than 50, even though they accounted for only 34.4% of influenza-related symptomatic illnesses. Furthermore, 70.6% of deaths were in adults older than 65, even though they had only 8.8% of illnesses.\n <\/p>\n

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\nSenior woman having the flu<\/span>\n<\/div>\n
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\nTested positive for flu this holiday season? Here\u2019s what you should do<\/span>\n<\/p>\n

6 min read<\/div>\n<\/div>\n<\/section>\n<\/div>\n

\n Flu vaccines are not designed to prevent minor illness, but they are much more effective at preventing severe illness, according to Poland.\n <\/p>\n

\n \u201cYou might have had mild flu, but you didn\u2019t get a plastic tube down your throat and put on a ventilator,\u201d Poland said. \u201cIn fact, you didn\u2019t even get hospitalized.\u201d\n <\/p>\n

\n Vaccines against influenza have reduced seasonal flu burden since they were introduced in the 20th century.\n <\/p>\n

\n The flu \u201chas large ramifications that occur each year, and so everything we can do to prevent illness \u2014 particularly the most serious illness that requires admission to hospitals, admission to the intensive care unit and admissions to the cemetery \u2014 we would like to prevent as much of that as possible,\u201d Schaffner said. \u201cAnd the influenza vaccine is the single best way we have at the moment, imperfect as it is, in impacting everything that flu does in society.\u201d\n <\/p>

Read more Ken Paxton tries to tamp down growing Republican concerns about his Senate campaign<\/a><\/p>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

For older adults, the flu vaccine could look a little different this year.<\/p>\n","protected":false},"author":1,"featured_media":9712,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-9725","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health"],"yoast_head":"\nThe FDA approved the first mRNA flu vaccine for use in older adults. Here\u2019s what to know - Relocation Times<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/relocationtimess.com\/?p=9725\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The FDA approved the first mRNA flu vaccine for use in older adults. 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