On May 31, 2024, Moderna Inc. announced that the FDA approved the mRNA RSV vaccine, which will be marketed as mRESVIA. The novel mRNA RSV vaccine is indicated to protect adults aged 60 years and older from lower respiratory tract disease (LRTD) caused by RSV infection. The approval was granted under a breakthrough therapy designation, marking Moderna’s second FDA-approved mRNA vaccine.

mRESVIA is an RSV vaccine containing an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the virus’s surface and is essential for infection by helping it enter host cells. The prefusion conformation of the F protein is an essential target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine utilizes the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines.

Stéphane Bancel, CEO of Moderna, stated, “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform. mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.”

The FDA’s approval of mRESVIA was based on positive data from the phase III clinical trial ConquerRSV—a global study that included an estimated 37,000 adults aged 60 years or older in 22 countries.

The primary analysis with 3.7 months of median follow-up discovered a vaccine efficacy against RSV LRTD of 83.7% (95.88% CI, 66.0%, 92.2%). These results were published in The New England Journal of Medicine. A follow-up analysis of the primary endpoint was performed during the FDA review, including cases that started before the primary analysis cutoff date but were not confirmed until afterward. The results were consistent with the primary analysis vaccine effectiveness (VE) 78.7% (CI 62.9%, 87.8%) and were included in the U.S. package insert. Data from an additional longer-term analysis disclosed continued protection against RSV LRTD over 8.6 months' median follow-up.

In the phase III trial no serious safety concerns were identified, and the most commonly reported (≥10%) adverse reactions were injection-site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (25.6%), arthralgia (21.7%), axillary (underarm) swelling or tenderness (15.2%), and chills (11.6%).

Moderna anticipates having the novel mRNA vaccine available for eligible populations in the United States by the 2024/2025 respiratory virus season. Moreover, Moderna has filed for mRNA-1345 approval with regulators in multiple markets worldwide.

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