Moderna gets USFDA nod for RSV Vaccine mRESVIA in adults aged 18-59 at increased risk for RSV disease
Cambridge: Moderna, Inc. has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for mRESVIA (mRNA-1345), the Company's respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18-59 years of age who are at increased risk for disease.
This approval expands the previous indication of mRESVIA, which was approved in May 2024 for adults aged 60 years and older.
"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," said Stéphane Bancel, Chief Executive Officer of Moderna. "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."
While the risk of RSV is well recognized in infants and older adult populations, adults aged 18-59 years with chronic conditions are also vulnerable. Over one-third of adults aged 18-59 years have at least one underlying condition that puts them at increased risk of severe RSV disease, with disease burden and hospitalization rates in this population being comparable, or even exceeding, that observed in older adults.
This approval was supported by results from Moderna's Phase 3 study (NCT06067230), which evaluated the safety and immunogenicity of mRESVIA in adults aged 18-59 with underlying health conditions. The immune responses against both RSV-A and RSV-B met prespecified non-inferiority immunobridging criteria when compared to those observed in adults aged 60 years and older in the pivotal Phase 3, placebo-controlled safety and efficacy study. Comparable levels of neutralizing antibodies were observed across both the 18-49 and 50-59 age subgroups, supporting the vaccine's consistent immunogenicity profile in this at-risk, younger adult population. These findings were presented at the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) meeting in April 2025 and have been published in Clinical Infectious Diseases.
The vaccine was generally well-tolerated, and the most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia.
Moderna intends to have mRESVIA available for both younger adults at increased risk (ages 18-59) and older adults (ages 60+) in the U.S. for the 2025-2026 respiratory virus season.
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