The first mRNA-based flu vaccine is now available, but not everyone can receive it.
Moderna’s mFlusiva is the first flu vaccine in the United States to use messenger RNA technology, the same platform used in the Pfizer and Moderna COVID-19 vaccines. Scientists have long been interested in using mRNA against flu because vaccines can be produced more quickly, which could make it easier to adapt to changing flu strains.
It’s too soon to predict how bad the next flu season will be, and the Centers for Disease Control and Prevention (CDC) has not yet begun recording cases. The CDC recommends getting vaccinated before the end of October.
In a late-stage clinical trial, published in May in the New England Journal of Medicine, mFlusiva was found to be approximately 27% more effective than a conventional flu vaccine. The Food and Drug Administration (FDA) approved mFlusiva in August for people 50 and older, paving the way for the vaccine to reach pharmacies in time for this year’s flu season.
(A sexologist clarifies whether it is advisable to use AI as a counselor in the intimate life of a couple)
However, pharmacies note that the new vaccine is already causing confusion among some patients about who can receive it, how it compares to traditional flu vaccines and where they can find it.
Here’s what you need to know:
Who can get the new mRNA flu vaccine?
The mRNA vaccine is only available to people age 50 and older.
“If you are not yet 50, you should not be interested in this vaccine,” said Emlah Tubuo, an independent pharmacist in Ohio.
The FDA granted traditional authorization for adults ages 50 to 64 and accelerated authorization for people ages 65 and older, requiring Moderna to conduct another trial in that age group. People who do not want the mRNA vaccine can still receive a traditional flu vaccine.
The additional trial in adults 65 and older stems from a controversy that nearly derailed the vaccine’s authorization.
In a large clinical trial, Moderna compared mFlusiva to a standard-dose flu vaccine in people 65 and older, even though the CDC recommends a high-dose flu vaccine for that age group.
The FDA initially declined to review Moderna’s application for that reason, before backtracking and agreeing to a post-approval clinical trial. In June, the FDA’s independent vaccine advisory panel unanimously recommended approval of the vaccine for older adults.
People under 50 years of age will not be able to receive mFlusiva this flu season. Instead, they can receive one of the other flu vaccines approved for their age group.
How is the mRNA vaccine different from a traditional flu vaccine?
The biggest difference lies in how vaccines teach the immune system to recognize influenza.
Most traditional flu vaccines use an inactivated version of the virus – often grown in eggs – to teach the immune system how to fight it.
(An 18-year-old is the fourth person to die from measles this year in the US.)
MFlusiva uses a small fragment of genetic code to train the body to recognize and fight the flu virus. The mRNA from the vaccine is later broken down and does not remain in the body.
“It’s like a temporary instruction for your immune system to alert your body’s natural defenses to recognize the flu,” Tubuo explained. It takes about two weeks after vaccination to develop protection.
According to Brigid Groves, a pharmacist with the American Pharmacists Association, one point of confusion among patients is whether mFlusiva also protects against COVID-19. It’s not like that. The vaccine only targets flu and is different from Moderna’s combined COVID-19 and flu vaccine, which was approved by the European Union in April.
Like this year’s traditional seasonal flu vaccines, Moderna’s vaccine is trivalent and targets two influenza A strains and one influenza B strain.
Another difference is that Moderna’s vaccine can be manufactured faster, said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical Center.
Scientists typically must choose which flu strains to target months before flu season begins, giving them time to manufacture millions of doses. Traditional flu vaccines can take about six months to produce, while Moderna says mFlusiva can be manufactured in two or three months. That shorter time frame, 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.
Is the mRNA vaccine safe and effective?
Published data from a Phase 3 clinical trial suggest that mFlusiva should work better than a standard-dose flu vaccine. More than 40,000 adults ages 50 and older in 11 countries, including the United States, participated in the trial. The trial revealed that mFlusiva was approximately 27% more effective than the standard-dose vaccine in preventing laboratory-confirmed disease.
FDA reviewers did not identify any serious safety issues with the vaccine.
Rates of side effects – such as pain at the injection site, fatigue and headaches – were more common in the mFlusiva groupbut remained mild to moderate.
Schaffner noted that the higher rate of side effects could be “a reflection of the intensity with which the immune system responds to the vaccine.”
Will insurance cover the mFlusiva vaccine?
mFlusiva is coming to pharmacies without a formal recommendation from the CDC or its vaccine advisory committee, a step that is typically required for insurers to cover vaccines for free.
A spokesperson for AHIP, an association of health insurers, said it expects most private insurers to cover the vaccine.
Dorit Reiss, a vaccine policy expert at the University of California, San Francisco School of Law, noted that Medicare is required to fully cover the cost of seasonal flu vaccines approved by the FDA.
Reiss noted that it is still unclear, however, to what extent Medicaid will cover the new vaccine this season, as the program typically requires a formal recommendation from the CDC’s vaccine advisory committee.
According to the Centers for Medicare and Medicaid Services, mFlusiva is priced around $171 per dose without insurance. Depending on the pharmacy, the cost could be as low as $154, according to GoodRx.
Where can it be obtained?
As with any vaccine, your ability to receive it immediately will depend on your local pharmacy’s current availability and delivery schedule.
In a statement, a Moderna spokesperson said the company has begun distributing doses of mFlusiva throughout the United States.
CVS Health spokesperson Amy Thibault said mFlusiva is available at its U.S. pharmacies. A Walgreens spokesperson stated that it expects to begin receiving shipments of the vaccine any day now, although it will be available to patients in “limited quantities” this season.
Tubuo, the Ohio pharmacist, noted that demand for mFlusiva is low right now, noting that it is still early in the season and that most people are not looking to get vaccinated until October.
