TL;DR
Moderna says its mRNA flu vaccine, mFlusiva, is available at more than 13,000 locations, but the company planned a limited first-year launch after the vaccine was approved in August. People seeking it may need to use Moderna’s vaccine finder or call pharmacies; evidence comparing its clinical protection with enhanced flu vaccines is still lacking.
Moderna’s mRNA flu vaccine, mFlusiva, is available at more than 13,000 locations, the company told MedPage Today, but supply is limited in its first season after an August FDA approval. Adults age 50 and older who want the shot may need to check Moderna’s vaccine finder or call pharmacies, as many retailers had already ordered this season’s flu vaccines before the approval.
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Moderna described the rollout as a “limited launch in year one.” The company provided MedPage Today with a link to its vaccine finder. Amesh Adalja, MD, of the Johns Hopkins Center for Health Security, said people seeking mFlusiva should use the site or call around because pharmacies may not distinguish among flu vaccine products when placing orders.
The vaccine is approved for adults ages 50 and older. The FDA granted traditional approval for people ages 50 to 64 and accelerated approval for those 65 and older. For the older group, the agency called for a postmarketing effectiveness study, ideally comparing mFlusiva with an enhanced flu vaccine.
Moderna’s pivotal phase III trial compared the mRNA vaccine with a standard-dose flu shot, rather than an enhanced vaccine. A separate study in adults 65 and older found a stronger immune response than Fluzone High-Dose, but it did not measure clinical outcomes. The available evidence therefore does not establish whether mFlusiva prevents more cases of flu or severe illness than enhanced vaccines.
Finding a Dose After Late Approval
The timing of approval matters for people trying to choose a specific vaccine. Retail pharmacy chains had placed orders for the season’s supply before the FDA cleared mFlusiva in August, according to the MedPage Today report. That left less time to distribute and stock the new product, while questions about demand also remain. A location finder can help identify listed sites, but patients may still need to confirm availability directly with a pharmacy.
Access is only one part of the decision. The reported trial data show more injection-site pain, fatigue, headache and muscle pain with mFlusiva than with standard-dose flu shots. William Schaffner, MD, of Vanderbilt University said the immune response appears stronger in some respects, while whether that leads to better protection remains unknown. People weighing the shot against another available vaccine may want to discuss their options with a healthcare professional, particularly if they have questions about side effects or eligibility.
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How mFlusiva Fits the Vaccine Options
U.S. flu vaccines include standard-dose shots made by growing influenza virus in eggs, as well as nasal spray, recombinant and cell-based products. Enhanced options include Flublok, a recombinant vaccine; Flucelvax, made using cell-based methods; and, for adults 65 and older, Fluzone High-Dose and the adjuvanted vaccine Fluad. mFlusiva is the mRNA option in the lineup described by the report. The CDC has said U.S. flu vaccines are trivalent because the B/Yamagata lineage stopped circulating after March 2020.
The FDA’s review of mFlusiva included disagreement over its clinical-trial comparator. The agency initially declined to review Moderna’s application over concerns that the pivotal study did not use a more suitable comparator, then reversed its decision a week later. The resulting approval included different terms for the two age groups and a further effectiveness study for adults 65 and older.
Adalja told MedPage Today that he favors Flublok or mFlusiva based on his reading of the data, while acknowledging the lack of strong head-to-head clinical-outcome studies comparing mFlusiva with other enhanced vaccines. His preference is an expert’s assessment, not evidence that one vaccine is best for every patient.
““If someone wants to get mFlusiva, they’re going to have to use that website or call around.””
— Amesh Adalja, MD, Johns Hopkins Center for Health Security
Protection and Local Supply Remain Open
How many doses are available at any particular pharmacy is not established by the company’s figure of more than 13,000 locations. The report does not give a dose count, a geographic breakdown, or details on how frequently the location finder is updated. A listing may not confirm that a pharmacy has a dose in stock, so patients may need to call before traveling.
The comparative effectiveness question is also unresolved. The pivotal trial compared mFlusiva with a standard-dose vaccine, and the separate comparison with Fluzone High-Dose measured immune response rather than clinical outcomes. The FDA-required postmarketing study for people 65 and older is intended to add effectiveness evidence, but the report does not provide its start date or expected results. It is also unclear whether pharmacies will expand orders if demand exceeds expectations.
Check Stock and Watch for Study Data
People looking for mFlusiva can start with Moderna’s vaccine finder, then contact a listed pharmacy to confirm that doses are on hand and ask about appointment availability. Those unable to find it can ask a healthcare professional or pharmacist about other flu vaccines available to them. The report does not say that people should delay vaccination while searching for a particular product. Schaffner said flu activity had started early in many parts of the country and urged people who were not vaccinated to get an available vaccine.
Further evidence will depend in part on the postmarketing effectiveness study required for adults 65 and older. The FDA’s approval terms call for that work, ideally against an enhanced vaccine, but its schedule and eventual findings were not specified in the report. For now, patients have to make decisions with limited direct clinical comparisons and check local supply as they seek a dose.
Key Questions
Where can I look for mFlusiva?
Moderna gave MedPage Today a link to its vaccine finder and said the shot was available at more than 13,000 locations. Call a pharmacy listed near you to confirm that it has doses available.
Who is eligible for the mRNA flu shot?
The FDA approved mFlusiva for adults age 50 and older. The approval is traditional for ages 50 to 64 and accelerated for those 65 and older, with a postmarketing effectiveness study required for the older group.
Has mFlusiva been shown to work better than enhanced flu shots?
The evidence described in the report does not answer that question. A study found a stronger immune response than Fluzone High-Dose in adults 65 and older, but it did not measure clinical outcomes. The pivotal trial compared mFlusiva with a standard-dose vaccine.
Should I wait until I find mFlusiva?
The report does not advise waiting for a specific product. Schaffner urged people who had not been vaccinated to get an available flu vaccine as flu activity had begun early in parts of the country. Ask a healthcare professional or pharmacist about options that fit your circumstances.
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