Moderna has received the US Food and Drug Administration (FDA) approval for mRESVIA, its respiratory syncytial virus (RSV) vaccine for adults at increased risk of RSV disease.
The FDA approval expands the vaccine’s initial approval, granted in May 2024, for administration in adults aged 60 and older.
mRESVIA employs an mRNA sequence encoding a stabilised prefusion F glycoprotein, crucial for RSV infection.
The glycoprotein facilitates viral entry into host cells and is a key target for neutralising antibodies.
The vaccine leverages lipid nanoparticles identical to those in Moderna’s Covid-19 vaccines, ensuring effective delivery.
Moderna CEO Stéphane Bancel said: “RSV poses a serious health risk to adults with certain chronic conditions, and today’s approval marks an important step forward in our ability to protect additional populations from severe illness from RSV.
“We appreciate the FDA’s review and thank all the participants in our clinical trial as well as the Moderna team for their dedication to protecting people against RSV.”
The FDA’s decision was based on results from Moderna’s Phase 3 study (NCT06067230), which assessed the vaccine’s safety and immunogenicity in adults aged 18-59 with underlying health conditions.
The study demonstrated that immune responses against RSV-A and RSV-B met prespecified non-inferiority criteria compared to responses in adults aged 60 and older.
Consistent levels of neutralising antibodies were observed across the 18-49 and 50-59 age groups, indicating a reliable immunogenicity profile for at-risk younger adults.
The findings were shared at the US Centres for Disease Control and Prevention’s (CDC) Advisory Committee on Immunisation Practices meeting in April 2025.
The vaccine was generally well-tolerated, with common adverse reactions including injection site pain, fatigue, headache, myalgia, and arthralgia.
Moderna plans to make mRESVIA available for both younger and older adults in the US during the 2025-2026 respiratory virus season.
Last year, Moderna announced that its manufacturing facility in Laval, Quebec, secured a Drug Establishment License (DEL) from Health Canada.
The certification affirms the facility’s compliance with rigorous safety and quality standards, authorising it to produce drug substance.
