
01
The first mRNA flu shot is now available. Here’s who can get it.
The gist: Moderna’s mFlusiva is the first U.S. mRNA flu vaccine, but it is available only to people 50 and older.
Big picturemRNA technology could make flu vaccines faster to produce, which may help scientists choose targets closer to the start of flu season. Early trial results suggest mFlusiva worked better than a standard-dose flu shot, though it is still only approved for older adults.
Explain like I'm 5This shot gives your body a tiny set of instructions so it can learn to spot the flu. The instructions disappear afterward, like a note your body reads and then throws away.
Why it matters nowThe FDA approved mFlusiva in August, allowing pharmacies to offer it for this flu season, and the CDC recommends vaccination by the end of October. Patients may face confusion about eligibility, supply, insurance coverage and how it differs from regular flu shots.
Three things to know01Approval differs by age
The FDA fully approved mFlusiva for adults ages 50 to 64 but gave accelerated approval to those 65 and older while Moderna conducts another trial.
02It does not prevent Covid
MFlusiva is a separate trivalent flu vaccine targeting two influenza A strains and one influenza B strain, not a combined flu-and-Covid shot.
03Coverage may vary
The vaccine costs about $171 per dose without insurance, while Medicare must cover FDA-approved seasonal flu shots but Medicaid coverage remains uncertain.
Trusted source
NBC News Health ↗

02
The Drugs and Devices Have Been on the Market for Years. But FDA-Ordered Studies Still Aren’t Done.
The gist: The FDA sometimes lets products reach patients while requiring later research, but hundreds of postmarket studies are delayed, leaving important safety questions unresolved.
Big pictureThis approach can give people faster access to treatments, especially when they have few options, but it shifts some safety checking until after approval. That makes reliable follow-up especially important as the FDA considers requiring fewer studies before approval.
Explain like I'm 5Sometimes the FDA lets a medicine or device go on sale while the company keeps checking how safe and useful it is. If that follow-up work is late, doctors and patients are making choices with missing information.
Why it matters nowIn February, FDA leaders said one clinical trial would generally become the default for approval, increasing the importance of postmarket research. The latest FDA data cited by KFF showed nearly 600 studies behind schedule.
Three things to know01Tavneos study barely started
As of last fall, only 21 of the planned 300 patients had joined the study, even as the FDA identified dozens of possible or probable cases of liver damage.
02Delays span many products
The nearly 600 delayed drug and biologic studies involved almost 350 products, and about a third of ongoing studies in the database were listed as delayed.
03Delay does not prove harm
The FDA says a late study can have legitimate, case-specific reasons and is not by itself proof that a product has an unresolved safety or effectiveness problem.
Trusted source
KFF Health News ↗

03
Doctors raise concerns about views and experience of members on federal task force
The gist: Robert F. Kennedy Jr. has appointed more specialists, rather than primary-care experts, to the federal panel that guides preventive care and insurance coverage, prompting concerns about its recommendations.
Big pictureThe U.S. Preventive Services Task Force influences recommendations ranging from cancer screenings to medicines and mental-health prevention. Its advice can also affect whether insurers cover preventive services without charging patients, so changes to its membership could affect care across the country.
Explain like I'm 5The panel is like a team that helps doctors decide which checkups and treatments can keep people healthy. Some doctors worry the new team members may focus too much on tests for their own specialties, instead of looking at the whole person.
Why it matters nowKennedy announced the new members Thursday, including radiologists, gastroenterologists, and cardiologists. The administration has not yet released information about possible conflicts of interest, while the task force has not responded to NPR's questions.
Three things to know01Screening can cause harm
A false alarm may lead to follow-up procedures such as biopsies, which can bring risks and complications.
02Primary care sees the whole patient
Primary-care doctors weigh screening benefits and harms across different ages, conditions, and body systems rather than focusing on one specialty.
03Conflicts remain undisclosed
Officials have not said whether any new members have financial ties to companies that could profit from preventive services.
Trusted source
NPR Health ↗