Moderna Just Took mRNA Beyond Covid

FDA approval of America’s first mRNA flu vaccine gives Moderna its clearest opportunity yet to build a lasting pharmaceutical business beyond Covid.

Moderna has spent years trying to prove that mRNA technology can support a lasting pharmaceutical business beyond the pandemic. Its newly approved flu vaccine may be its most important opportunity yet.

The US Food and Drug Administration has approved mFlusiva for adults aged 50 and older, making it the first mRNA-based seasonal flu vaccine authorised in the country.

The approval was supported by a late-stage trial involving more than 40,000 adults. Moderna’s vaccine was 26.6% more effective at preventing influenza than a standard-dose flu shot. It also reduced severe cases requiring hospital or urgent care and produced stronger immune responses than a high-dose vaccine in a separate study of older adults.

Approval differs slightly between age groups. MFlusiva received traditional approval for adults aged 50 to 64, while its approval for people aged 65 and older was granted under the FDA’s accelerated pathway. Moderna must conduct an additional study to confirm its effectiveness among older patients.

The technology could offer an important advantage over traditional flu vaccines. Many existing shots are produced using eggs, a process that can take months and requires manufacturers to select targeted flu strains well before the season begins. An mRNA vaccine can be developed and updated more quickly, potentially allowing it to better match the strains that eventually circulate.

For Moderna, however, this is also a business test. Revenue from its Covid vaccine has fallen sharply since the height of the pandemic, leaving the company searching for products that can justify its research spending and rebuild investor confidence.

MFlusiva will enter a competitive market with established vaccines from Sanofi, GSK and CSL Seqirus. Moderna must persuade doctors, pharmacies and health systems that its improved trial results are enough to support adoption. The vaccine is also unlikely to make a significant financial contribution immediately because many purchasing decisions for the coming flu season have already been made.

Even so, the approval gives Moderna a product aimed at a large and recurring market. Seasonal flu vaccination is needed every year, offering a more predictable opportunity than emergency pandemic demand.

MFlusiva will not settle every question surrounding Moderna’s future. It does, however, move mRNA into one of the world’s largest established vaccine markets. The next challenge is proving that scientific success can become a durable commercial business.