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Does Moderna's mRNA Flu Shot Face a New Challenge From GSK?

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Key Takeaways

  • Moderna's mFlusiva is the first mRNA-based seasonal flu vaccine approved by the FDA.
  • GSK's mRNA flu candidate targets HA and NA, generating higher immune responses in a phase II study.
  • Moderna has time to establish mFlusiva before GSK's candidate potentially reaches the market.

Moderna (MRNA - Free Report) recently secured FDA approval for mFlusiva, the first mRNA-based seasonal flu vaccine. The decision is a significant milestone for the company, which gets an opportunity to establish a foothold in another multibillion-dollar market while further diversifying its revenue base beyond COVID-19 vaccines.

However, even before Moderna has had much time to establish its newly approved vaccine in the market, a new competitive challenge has emerged. GSK plc (GSK - Free Report) recently announced plans to advance its investigational mRNA-based flu vaccine into late-stage development later this month, following positive phase II study results.

GSK’s Move Reinforces Confidence in Moderna’s mRNA Platform

Moderna has recently undergone a significant shift in investor sentiment following the positive late-stage results for its personalized mRNA cancer therapy developed with partner Merck (MRK - Free Report) . The results have helped reinforce the potential of Moderna’s mRNA technology beyond infectious diseases, particularly oncology, providing another indication that the platform could support growth across multiple therapeutic areas.

GSK’s decision to advance an mRNA-based flu vaccine into phase III development could also be viewed as another sign that large pharmaceutical companies increasingly see mRNA as a viable next-generation technology. Rather than being viewed solely as a competitive development, GSK’s investment in the technology could further strengthen confidence in the broader mRNA platform and its potential across vaccine applications.

GSK’s Vaccine Could Also Raise the Competitive Bar for Moderna

GSK’s candidate is important not simply because it uses mRNA, but because it is designed to target two proteins on the surface of the flu virus — hemagglutinin (HA) and neuraminidase (NA). HA helps the virus attach to and enter cells, while NA facilitates the spread of newly formed virus particles from infected cells. By targeting both proteins, GSK is pursuing a potentially broader approach to flu prevention.

That distinction matters for Moderna because, like most existing flu vaccines, mFlusiva is based on targeting HA. GSK’s advancement of the mRNA vaccine is supported by results from a phase II study, which showed that its flu vaccine generated higher immune responses than standard-dose vaccines in younger adults and high-dose vaccines in older adults.

This could potentially position GSK’s candidate as a differentiated competitor to Moderna once it reaches the market. However, GSK’s vaccine is still at least a couple of years away from reaching the market and is subject to phase III results, where its efficacy will be tested. This gives Moderna valuable time to establish mFlusiva in the market and build awareness before GSK potentially arrives.

Meanwhile, Moderna’s mFlusiva will compete for market share against established non-mRNA-based flu vaccines marketed by GSK, Sanofi (SNY - Free Report) and CSL Seqirus, all of which have a significant presence in the seasonal influenza market.

MRNA’s Price Performance, Valuation & Estimates

Shares of Moderna have skyrocketed more than 400% year to date, significantly outperforming the industry’s 10% growth.

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From a valuation standpoint, the company is currently trading at a premium to the industry. Based on the price-to-sales (P/S) ratio, the stock trades at 24.28 times forward 12-month sales, higher than the industry average of 1.94 times.

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Estimates for Moderna’s 2026 and 2027 loss per share have improved over the past 30 days.

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Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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