Moderna’s mFlusiva is the first flu vaccine in the United States to use messenger RNA technology, the same platform used in Pfizer and Moderna’s Covid shots.
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mFlusiva → use → Pfizer
Scientists have long been interested in using mRNA against the flu because the vaccines can be made faster, potentially making it easier to keep up with changing flu strains.
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it → use → strains
It’s too early to predict how severe the upcoming flu season will be and the Centers for Disease Control and Prevention hasn’t started tracking cases yet.
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Centers → ’ → cases
The CDC recommends getting vaccinated by the end of October.
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CDC → recommend → October
In a late-stage clinical trial, published in the New England Journal of Medicine in May, mFlusiva was found to be about 27% more effective than a standard flu shot.
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mFlusiva → publish → shot
The Food and Drug Administration approved mFlusiva in August for people 50 and older, clearing the way for the shot to reach pharmacies in time for this year’s flu season.
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shot → approve → season
Pharmacies, however, say the new vaccine is already causing confusion among some patients about who can get it, how it compares with traditional flu shots and where people will be able to find it.
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people → say → it
Here’s what you need to know:
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you → ’ → what
Who can get the new mRNA flu shot?
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Who → get → shot
“If you have not celebrated your 50th birthday, this vaccine should be of no interest to you,” said Emlah Tubuo, an independent pharmacist in Ohio.
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Tubuo → celebrate → Ohio
The FDA granted traditional approval for adults 50 to 64 and accelerated approval for people 65 and older, with Moderna required to conduct another trial in that age group.
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Moderna → grant → group
People who do not want the mRNA vaccine can still get a traditional flu shot.
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who → want → shot
The additional trial in adults 65 and older stems from a controversy that nearly derailed the vaccine’s approval.
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that → stem → approval
In a large clinical trial, Moderna compared mFlusiva with a standard-dose flu shot in people 65 and older, even though the CDC recommends a high-dose flu shot for that age group.
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CDC → compare → group
The FDA initially refused to review Moderna’s application over that issue before reversing course and agreeing to a post-approval clinical trial.
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FDA → refuse → trial
In June, the FDA’s independent vaccine advisory panel unanimously recommended the approval of the vaccine for older adults.
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panel → recommend → adults
People younger than 50 won’t be able to get mFlusiva this flu season.
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People → get → mFlusiva
Instead, they can get one of the other flu vaccines approved for their age group.
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one → get → group
The biggest difference is how the vaccines teach the immune system to recognize influenza.
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vaccines → teach → influenza
Most traditional flu shots use a deactivated version of the virus — often grown in eggs — to teach the immune system how to fight it.
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shots → use → it
MFlusiva uses a small snippet of genetic code to train the body to recognize and fight the flu virus.
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MFlusiva → use → virus
The mRNA from the vaccine is then broken down and does not remain in the body.
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mRNA → break → body
“It’s like a temporary instruction to your immune system to alert your body’s natural defense to recognize influenza,” Tubuo said.
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Tubuo → ’ → influenza
It takes about two weeks after vaccination to build protection.
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It → take → protection
One point of confusion among patients, according to Brigid Groves, a pharmacist with the American Pharmacists Association, is whether mFlusiva also protects against Covid.
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mFlusiva → accord → Covid
It doesn’t.
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It → do → ?
The vaccine only targets the flu and is separate from Moderna’s combination Covid and flu vaccine, which was approved by the European Union in April.
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which → target → April
Like the traditional seasonal flu vaccines this year, Moderna’s shot is a trivalent vaccine, targeting two influenza A strains and one influenza B strain.
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shot → target → strains
Another difference is that Moderna’s vaccine can be made faster, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.
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Schaffner → make → Center
Scientists typically have to choose which flu strains to target months before flu season begins, leaving time to manufacture millions of doses.
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season → have → doses
Traditional flu vaccines can take about six months to produce, while Moderna says mFlusiva can be made in two to three months.
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mFlusiva → take → months
That shorter timeline, Schaffner said, allows them to wait longer before choosing which strains to target, giving them a better idea of which ones are likely to circulate.
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ones → say → idea
Published data from a Phase 3 clinical trial suggests mFlusiva should work better than a standard-dose flu shot.
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mFlusiva → publish → shot
More than 40,000 adults 50 and older across 11 countries, including the United States, participated in the trial.
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adults → include → trial
The trial found mFlusiva was about 27% more effective than the standard-dose vaccine at preventing laboratory-confirmed illness.
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mFlusiva → find → illness
FDA reviewers did not identify any serious safety problems with the vaccine.
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reviewers → identify → vaccine
Schaffner said the higher rate of side effects may be “a reflection of the vigor with which the immune system responds to the vaccine.”
Will insurance cover mFlusiva?
MFlusiva is reaching pharmacies without a formal recommendation from the CDC or its vaccine advisory committee, a step typically needed to require insurers to cover vaccines for free.
A spokesperson for AHIP, a trade group for health insurers, said it expects most private insurers will cover the vaccine.
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insurers → say → vaccine
Dorit Reiss, a vaccine policy expert at University of California Law San Francisco, said Medicare is required to fully cover the cost of FDA-approved seasonal flu shots.
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Medicare → say → shots
Reiss said it remains unclear, however, how widely Medicaid will cover the new shot this season, as the program typically requires a formal recommendation from the CDC’s vaccine advisory committee.
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program → say → committee
According to the Centers for Medicare and Medicaid Services, mFlusiva has a price tag of around $171 per dose without insurance.
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mFlusiva → accord → insurance
…and 7 more, not listed.
The Aporia
