Tuesday, June 18, 2024

Respiratory Syncytial Virus Vaccine mResvia Gains FDA Approval, Bolstering Moderna’s Market Position

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Respiratory syncytial virus (RSV) vaccine mResvia (formerly mRNA-1345) has secured FDA approval, marking a significant milestone for Moderna as it seeks to diversify its revenue sources amidst declining sales of its COVID-19 vaccine, Spikevax. The mRNA-based mResvia is approved to protect older adults aged 60 and over from lower respiratory tract disease caused by respiratory syncytial virus infection, positioning it to compete with GSK’s Arexvy and Pfizer’s Abrysvo in the U.S. market.

According to mResvia’s prescribing information, the vaccine demonstrated 78.7% efficacy in preventing respiratory syncytial virus with two or more symptoms at 3.7 months of follow-up. However, this efficacy dropped to 62.5% at 8.6 months, a figure slightly lower than what was reported in the pivotal trial published in the New England Journal of Medicine. This revised efficacy data caused a slight dip in Moderna’s shares upon the approval announcement, as noted by analysts at William Blair.

Despite the revised efficacy, mResvia’s performance is competitive. It is slightly less effective than GSK’s Arexvy but slightly more effective than Pfizer’s Abrysvo, though these comparisons are based on different study designs. A key advantage for mResvia is its prefilled syringe formulation, which enhances convenience, and the absence of reported cases of Guillain-Barré syndrome (GBS), a rare side effect associated with both GSK and Pfizer’s respiratory syncytial virus vaccines.

mResvia Awaits CDC Endorsement to Enter Respiratory Syncytial Virus Vaccine Market

Before mResvia can compete directly with Arexvy and Abrysvo, it must receive an endorsement from the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP), which is expected to meet from June 26th to 28th. This endorsement is crucial for mResvia’s market entry and subsequent commercial success.

Currently, GSK’s Arexvy leads the market, generating approximately $1.6 billion in sales last year, followed by Pfizer’s Abrysvo with $890 million, the latter also approved for maternal use to prevent respiratory syncytial virus in newborns and infants. Analysts at William Blair project that mResvia could capture around 27% of the U.S. market, translating to approximately $1.5 billion in revenue by 2033.

Respiratory Syncytial Virus

mResvia’s Market Potential and Impact on Moderna’s Revenue Growth Strategy

While mResvia may not have the top efficacy profile, it holds significant market potential due to its ease of administration and safety profile. The focus will now shift to the ACIP’s recommendation and the potential for commercial contracting, both critical for Moderna’s strategy to boost top-line revenue growth by 2025 and achieve breakeven by 2026.

Moderna’s Spikevax generated $6.7 billion in sales last year, a sharp decline from $18.4 billion in the previous year, with sales further dropping to $167 million in the first quarter of 2024. The company anticipates total revenues of $4 billion this year, primarily driven by sales of its updated Spikevax version and mResvia.

The FDA’s approval of mResvia represents a pivotal step for Moderna as it strives to establish a stable revenue stream beyond its COVID-19 vaccine. With the expected ACIP endorsement and successful market entry, mResvia has the potential to significantly impact the respiratory syncytial virus vaccine market, offering a new option for older adults and contributing to Moderna’s long-term financial stability and growth.

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Resource: Moderna, May 31, 2024

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