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FDA approves Moderna’s first mRNA flu vaccine for older adults

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The U.S. Food and Drug Administration has approved Moderna’s first messenger RNA-based influenza vaccine, marking the first flu shot to use the same technology that powered the company’s COVID-19 vaccines.

The vaccine, marketed as mFlusiva, is approved for adults age 50 and older and is expected to be available in time for the 2026-27 flu season.

The decision follows an unusually complicated seven-month review process. In February, the FDA initially declined to review Moderna’s application, citing concerns that the company’s clinical trial for older adults compared the vaccine with a standard-dose flu shot rather than the high-dose version typically recommended for seniors. After Moderna submitted a revised plan that included an additional study, the agency resumed its review. An FDA advisory committee unanimously recommended approval in June.

Traditional flu vaccines are produced using chicken eggs, a manufacturing process that takes about six months and requires developers to predict which influenza strains will circulate months before flu season. Moderna’s mRNA technology can produce a vaccine in as little as two to three months, allowing manufacturers to better match circulating strains if needed.

In a clinical trial involving more than 40,000 adults, mFlusiva reduced the risk of influenza by 26.6% compared with a standard-dose flu vaccine. It also reduced the risk of severe influenza requiring hospitalization or urgent care by nearly 48%.

The approval comes as debate continues over mRNA vaccines. Health Secretary Robert F. Kennedy Jr. has questioned the technology, and the Department of Health and Human Services previously canceled hundreds of millions of dollars in mRNA research funding. The vaccine’s commercial rollout may also be affected by uncertainty surrounding recommendations from the Centers for Disease Control and Prevention’s vaccine advisory panel, which has faced legal and organizational challenges.

Moderna is also conducting a large follow-up study involving up to 800,000 participants over two flu seasons to compare the vaccine with the high-dose flu shot recommended for adults 65 and older.

The approval could also advance development of Moderna’s combined COVID-19 and influenza vaccine, which the company previously withdrew from FDA review after regulators requested additional flu vaccine data.

Source: WSJ

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