Pharma Focus Asia

FDA Approves Moderna's RSV Vaccine, mRESVIA(R)

Monday, June 03, 2024

Moderna, Inc. (NASDAQ: MRNA) has received approval from the U.S. Food and Drug Administration (FDA) for mRESVIA (mRNA-1345), an mRNA vaccine designed to combat respiratory syncytial virus (RSV) in adults aged 60 years and older. This breakthrough therapy designation marks Moderna's second mRNA product approval, highlighting the versatility and effectiveness of its mRNA platform.

Moderna, emphasized the significance of this milestone, noting mRESVIA's ability to protect older adults from severe RSV-related lower respiratory tract disease. Notably, mRESVIA is the first mRNA vaccine approved for a disease other than COVID-19. Its unique pre-filled syringe design aims to streamline administration, saving time and minimizing potential errors for vaccinators.

RSV is a highly contagious respiratory virus, particularly impactful in infants and older adults, causing a substantial burden of disease including lower respiratory tract infections and pneumonia. In the U.S. alone, RSV leads to tens of thousands of hospitalizations and thousands of fatalities among older adults annually.

The FDA's approval of mRESVIA is based on positive outcomes in the Phase 3 clinical trial ConquerRSV, involving over 37,000 adults aged 60 and above across 22 countries. The trial demonstrated significant vaccine efficacy against RSV lower respiratory tract disease, with follow-up analysis confirming sustained protection over an extended period.

Safety remains a paramount concern, and the Phase 3 trial revealed no serious safety issues. Commonly reported adverse reactions included mild symptoms such as injection site pain, fatigue, headache, myalgia, and arthralgia.

Moderna anticipates making mRESVIA available for eligible populations in the U.S. ahead of the 2024/2025 respiratory virus season and has initiated regulatory filings for mRNA-1345 in various international markets.

mRESVIA, encoding a stabilized prefusion F glycoprotein, targets the F protein critical for RSV infection. This prefusion conformation represents a key target for neutralizing antibodies, offering broad protection against both RSV-A and RSV-B subtypes. Utilizing the same lipid nanoparticle technology as Moderna's COVID-19 vaccines, mRESVIA promises to advance the fight against infectious diseases on a global scale.



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