FDA Approves Moderna's mRESVIA, First mRNA Vaccine Against RSV, for Adults Aged ≥60 Years

The FDA has approved mRESVIA, previously mRNA-1345, making it the first mRNA technology-based vaccine against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older, according to biotechnology company Moderna.¹ In addition to offering the robust safety and efficacy demonstrated in the pivotal phase 3 ConquerRSV clinical trial, the vaccine will be packaged as a prefilled syringe, a benefit unique to the Moderna product that may help clinicians and pharmacists save time.¹

Moderna projects that mRESVIA, will be available for eligible adults during the upcoming 2024-2025 RSV season.¹

"The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," Stéphane Bancel, Moderna chief executive officer, said in the announcement.¹ "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.¹

The approval is a landmark for mRNA vaccines, representing the “first time an mRNA vaccine has been approved for a disease other than COVID-19,” Bancel continued.¹

The FDA's approval of mRESVIA is based on findings from ConquerRSV, a global randomized, double-blind, placebo-controlled trial that included approximately 37 000 adults aged 60 years and older conducted across 22 countries.² The dual primary efficacy endpoints were based on 2 definitions of RSV-LRTD—RSV-LRTD with 2 or more symptoms and RSV-LRTD with 3 or more symptoms of disease. Participants were randomly assigned to receive a single dose of the investigational vaccine or placebo.²

Based on analyses conducted when at least half of the anticipated cases of RSV-LRTD had occurred, vaccine efficacy was 83.7% against the disease with at least 2 signs or symptoms and 82.4% effective against RSV-LRTD with at least 3 signs or symptoms.² The findings were published in the New England Journal of Medicine in December 2023.²

During the FDA review, ConquerRSV investigators performed a follow-up analysis that included clinical trial cases that had begun before the cut-off date for the primary analysis but were not confirmed until afterward, the company said. Moderna reported vaccine efficacy (VE) findings consistent with results from the initial analysis (VE 78.7%) and the latter were included in the final US package insert. Further, a separate and longer-term analysis demonstrated ongoing protection from RSV LRTD in the older adult population over 8.6 months.¹ Across analyses, mRESVIA provided equal protection against RSV subtypes A and B.

There were no serious safety concerns observed in the phase 3 ConquerRSV trial and the most commonly reported solicited adverse reactions were Local injection site pain, fatigue, headache and arthralgias and myalgias, the company noted. ²

mRESVIA, has a single mRNA sequence encoding for a stabilized prefusion F glycoprotein and uses the same lipid nanoparticles as Moderna’s COVID-19 vaccines. It is the only RSV vaccine based on an mRNA technology platform and the second approved mRNA product from Moderna.

References

1. Moderna receives US FDA approval for RSV vaccine mRESVIA. News release. Moderna. May 31, 2024. Accessed June 2, 2024.
2. Wilson E, Goswami J, Gaqui AG, et al, for the ConquerRSV Study. Efficacy and safety of an mRNA-based RSV PreF Vaccine in older adults. New Eng J Med. 2023;389(24):2233-2244. doi: 10.1056/NEJMoa2307079https://www.nejm.org/doi/full/10.1056/NEJMoa2307079?query=featured_home