US FDA approves expanded use of Moderna's RSV vaccine for at-risk adults

The FDA has expanded the approved use of Moderna's mRESVIA, an mRNA-based RSV vaccine, to include adults aged 18-59 at increased risk, in addition to the previously approved 60+ age group. This decision was based on trial data showing significant immune responses and tolerability in the younger at-risk group; however, CDC recommendation is still required for the vaccine to be available for this expanded population. Concurrently, concerns are rising regarding potential impacts on public confidence in vaccines, stemming from recent appointments to the CDC's vaccine advisory panel of members with anti-vaccine views.

Analysis

The U.S. Food and Drug Administration (FDA) has expanded the approved use of Moderna's (MRNA) respiratory syncytial virus (RSV) vaccine, mRESVIA, to include adults aged 18 to 59 years at increased risk for the disease, a significant development as this is Moderna's second commercial product and its first non-COVID-19 mRNA vaccine. This approval, based on late-stage trial data demonstrating significant immune responses and good tolerability within this younger demographic, broadens the potential market for mRESVIA beyond its initial approval for adults aged 60 and older where it demonstrated 79% efficacy in preventing at least two symptoms. However, commercial availability for the 18-59 age group is contingent upon a forthcoming recommendation from the U.S. Centers for Disease Control and Prevention (CDC), whose Advisory Committee on Immunization Practices (ACIP) is scheduled to meet later this month. The competitive landscape is established, with Pfizer's (PFE) Abrysvo already approved for at-risk adults 18-59 and GSK's (GSK) Arexvy approved for at-risk adults 50-59. A notable uncertainty arises from the recent replacement of all members of the CDC's ACIP, with some new appointees reportedly holding anti-vaccine views, which could influence the CDC's recommendation and potentially impact public confidence in vaccines, despite an estimated 15,000–20,000 annual RSV-associated hospitalizations in the U.S. for adults aged 50 to 59.

Key Decisions for Investors

• For Moderna (MRNA), the FDA's expanded approval for mRESVIA offers a potential revenue upside, but investors should closely monitor the upcoming CDC advisory panel's recommendation and subsequent market adoption dynamics given existing competition from Pfizer and GSK.
• Investors should consider the broader implications of the reconstituted CDC advisory panel, as changes in its composition and guidance could impact vaccine sentiment and uptake beyond just RSV, potentially affecting other vaccine manufacturers and the overall public health landscape.
• Closely track the outcomes of the upcoming ACIP meeting, as its recommendations will be a critical determinant for mRESVIA's access to the 18-59 at-risk population and may signal shifts in U.S. public health policy regarding vaccinations.