Equities

Moderna's Dual Covid-Flu Shot Aces Trials, Targets 2025 Launch

Moderna's combined Covid and flu vaccine shows efficacy in 8,000 adults, aiming for FDA approval by next summer.

By Bill Bullington

6/10, 07:20 EDT
Moderna, Inc.
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Key Takeaway

  • Moderna's combined Covid-19 and flu vaccine matched the efficacy of single shots in a phase-three trial with over 8,000 adults.
  • The company aims to launch the combined shot by winter 2025, targeting the $8 billion seasonal flu market.
  • Despite a projected decline in Covid jab sales, Moderna's share price has risen 37% this year due to interest in its H5 pandemic flu vaccine candidate.

Combined Vaccine Efficacy

Moderna announced on Monday that its combined Covid-19 and flu vaccine has matched the efficacy of single shots in late-stage trial results. The phase-three trial, which studied antibody responses in over 8,000 adults aged 50 and above, demonstrated that the combination vaccine was as effective as Moderna's standalone Covid shot. The trial also compared the combined vaccine to two popular seasonal flu jabs, Fluzone and Fluarix, which were administered selectively to different age groups. Notably, the combined shot showed higher efficacy when targeting three specific seasonal flu strains, including H1N1 swine flu. Moderna plans to publish the interim data in a peer-reviewed journal and submit it for US regulatory approval later this year. The company anticipates that the US Food and Drug Administration (FDA) could make an approval decision by next summer, potentially allowing the launch of the first combined Covid and flu shot by the 2025 winter season. Moderna also reported that the combined shot exhibited an "acceptable tolerability and safety profile."

Market Expansion and Diversification

With its share price down approximately 67% from its pandemic peak in late 2021, Moderna is actively working to diversify its product pipeline beyond Covid-related products. The company aims to leverage its messenger RNA (mRNA) vaccine platform to address other viruses and diseases, including cancer. Stéphane Bancel, Moderna's chief executive, highlighted that the launch of the first combined shot would grant the company access to the $8 billion seasonal flu jab market, which is larger than the market for Covid jabs. Bancel emphasized the added convenience of the combined shot, stating, "When you talk to doctors, they love the idea of combinations as they will result in higher uptake as it appeals to people who don’t like needles." Other companies, including Pfizer, BioNTech, Novavax, and Sanofi, are also developing dual-acting jabs. According to the Centers for Disease Control and Prevention (CDC), flu vaccine coverage in the US was more than double that of Covid shots in the latest season, with 48.5% of adults aged 18 and over receiving a flu shot, compared to 22.5% who received a Covid jab.

Financial Performance and Future Prospects

Moderna's global sales of its Covid jab are projected to total $3.9 billion this year, a 40% decline from the $6.6 billion in revenues last year. Despite this, Moderna's share price has risen 37% so far this year, giving the company a market value of $57 billion. This uptick has been driven by investor interest in the biotech's H5 pandemic flu vaccine candidate, which could be used to combat the US bird flu outbreak if it were to spill over from animals into humans. The improving share price has also led traders who have shorted Moderna's stock to close their positions, further boosting the share price. Bancel noted that the company's pipeline has proven that mRNA shots enable "speed of development, combo shots and vaccines that could tackle complex biology," adding, "Those are huge proof points for our platform." Last month, Moderna received US regulatory approval for its second-ever product: a vaccine targeting respiratory syncytial virus (RSV).

Street Views

  • Michael Yee, Jefferies (Bullish on Moderna):

    "The key test for Moderna’s combined jab was it proving 'non-inferior' to separately administered shots. Positive phase-three data from its combined shot trial could be a 'nice catalyst' for the stock."

Management Quotes

  • Stéphane Bancel, CEO of Moderna:

    "When you talk to doctors, they love the idea of combinations as they will result in higher uptake as it appeals to people who don’t like needles."
    "[Moderna] had proven through its pipeline that mRNA shots enabled 'speed of development, combo shots and vaccines that could tackle complex biology'. Those are huge proof points for our platform."