Moderna, Inc.

Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older CAMBRIDGE, MA, USA I June 12, 2025 I Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved 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. 1 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, 2 with disease burden and hospitalization rates in this population being comparable, or even exceeding, that observed in older adults. 3 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. About mRESVIA® (Respiratory Syncytial Virus Vaccine) mRESVIA® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines. About Moderna Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines. Moderna’s mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn. mRESVIA® is a registered trademark of Moderna. INDICATION mRESVIA is a vaccine to protect you against lower respiratory tract disease caused by Respiratory Syncytial Virus (RSV). mRESVIA is for people 60 years of age and older and also for people 18 through 59 years of age who are at increased risk for RSV (people with medical conditions such as diabetes or with diseases affecting the lungs and heart). Vaccination with mRESVIA may not protect all people who receive the vaccine. mRESVIA does not contain RSV. mRESVIA cannot give you lower respiratory tract disease caused by RSV. Please click for mRESVIA Full Prescribing Information. 1 Prasad N, Walker TA, Waite B, et al. Respiratory syncytial virus-associated hospitalizations among adults with chronic medical conditions. Clin Infect Dis 2021; 73(1): e158-e63. 2 Wilker E, Jiang M, Francis B, et al. Burden of chronic medical conditions that are risk factors for severe RSV among adults aged 18-59 years in the United States. Poster presented at: ESCMID; April 2025; Vienna, Austria. 3 Weycker D, Averin A, Houde L, et al. Rates of Lower Respiratory Tract Illness in US Adults by Age and Comorbidity Profile. Infect Dis Ther 2024; 13(1): 207-20. SOURCE: Moderna

Bengaluru: GSK has applied to the European Medicines Agency to expand use of its respiratory syncytial virus (RSV) vaccine to adults below the age of 50 who are at risk of the disease, the British drugmaker said on Friday. If approved in the European Union, the vaccine, Arexvy , would compete in the 18-49 age group with Pfizer 's Abrysvo. Arexvy is currently only approved in the EU for adults aged 60 and above, and for preventing RSV-related disease in at-risk adults aged 50 to 59. RSV is a common respiratory virus that causes seasonal infections such as the flu and is a leading cause of pneumonia and death in infants and older adults. While GSK's vaccine was the first RSV vaccine to be approved by European and U.S. authorities in 2023 for older adults, it has since lagged behind rivals and sales have fallen sharply. In the first quarter, Arexvy generated revenue of just 78 million pounds ($105.72 million), down 57% from a year earlier. GSK had expected Arexvy to be a blockbuster product, estimating peak annual sales of 3 billion pounds, but sales have missed market expectations for several quarters. An expanded approval could help GSK better compete with Pfizer's Abrysvo and Moderna's mRESVIA vaccine, and revive sales. On Thursday, U.S. regulators approved use of mRESVIA in adults aged 18 to 59 years at increased risk of disease. The EU's health regulator is expected to decide in the first half of 2026 on the expanded use of Arexvy, GSK said, adding that it was working on making similar applications to U.S. and Japanese regulators as well. In January, the U.S. Food and Drug Administration announced that GSK and Pfizer's RSV vaccines will carry warnings that the vaccines can increase the risk of developing Guillain-Barre syndrome, a rare neurological disorder. ($1 = 0.7378 pounds) (Reporting by Pushkala Aripaka in Bengaluru; Editing by Rashmi Aich and Susan Fenton)

Moderna gained expanded FDA approval of its respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345), allowing use of the mRNA-based shot in individuals 18-59 years of age who are at increased risk of disease. The jab was first cleared just over a year ago for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.Despite being only the third RSV vaccine approved in the US — behind GSK's Arexvy and Pfizer's Abrysvo — mRESVIA has so underperformed, bringing in sales of only $2 million in the first quarter of 2025, far below analyst estimates. CEO Stéphane Bancel previously conceded that Moderna had been "too optimistic" about its ability to break into the market.The executive also highlighted guidance from the Centers for Disease Control and Prevention (CDC) that voted last year to limit use of RSV vaccines to individuals 75 and older, as well as high-risk adults between the ages of 60 and 74, having previously said that all adults over the age of 60 "may receive" an RSV jab. More recently, the Advisory Committee on Immunization Practices (ACIP) voted to widen its recommendation to include adults ages 50 to 59 who are at an increased risk of severe RSV disease.Expanded approval of mRESVIA was supported by findings from a Phase III study in  adults aged 18-59 with underlying health conditions. Results showed that immune responses against both RSV-A and RSV-B met prespecified non-inferiority immunobridging criteria when compared to those seen in adults aged 60 years and older. Comparable levels of neutralising antibodies were also observed across both the 18-49 and 50-59 age subgroups.Moderna said that mRESVIA will be available for both younger adults at increased risk and older adults in time for the 2025-2026 respiratory virus season.