Moderna's FDA-approved mRNA vaccine, mRESVIA (mRNA-1345), protects adults 60 and older from RSV-related lower respiratory tract disease with 83.7% efficacy, aiming for U.S. availability by 2024/2025.

PARIS, FRANCE: Moderna, Inc. has announced the FDA approval of mRESVIA (mRNA-1345), a groundbreaking mRNA vaccine designed to protect adults aged 60 and older against lower respiratory tract disease caused by respiratory syncytial virus (RSV). This marks a significant milestone as the second mRNA product from Moderna to receive FDA approval under breakthrough therapy designation.

RSV, a highly contagious seasonal virus, poses a substantial health burden, particularly among infants and older adults in the U.S., where it annually leads to 60,000-160,000 hospitalizations and 6,000-10,000 deaths. The FDA's decision is supported by positive results from the Phase 3 clinical trial Conquer RSV, involving approximately 37,000 adults aged 60 and older across 22 countries. The primary analysis demonstrated an impressive vaccine efficacy of 83.7% against RSV lower respiratory tract disease (LRTD) after 3.7 months of median follow-up, as published in The New England Journal of Medicine. A subsequent FDA review confirmed consistent results, showing a vaccine efficacy of 78.7% over the longer term (8.6 months median follow-up).

Safety data from the trial indicated no serious concerns, with common adverse reactions including injection site pain, fatigue, headache, myalgia, and arthralgia. Moderna anticipates making mRESVIA available to eligible populations in the U.S. by the 2024/2025 respiratory virus season and has initiated approvals in other global markets.

mRESVIA works by utilizing mRNA technology to encode a stabilized prefusion F glycoprotein, critical for RSV infection, and employs lipid nanoparticles (LNPs) akin to those used in Moderna’s successful COVID-19 vaccines.

Moderna, a pioneer in mRNA medicine, continues to revolutionize healthcare through rapid and efficient development of vaccines and therapeutics across infectious diseases, immuno-oncology, rare diseases, and autoimmune conditions. With a commitment to advancing human health through innovative mRNA solutions, Moderna aims to address significant medical challenges globally.

Stéphane Bancel, Chief Executive Officer of Moderna said, “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.”