Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease
- FDA approval expands market reach to adults 18-59 at high risk for RSV
- Phase 3 study showed strong immune responses comparable to older adults
- Large addressable market with over one-third of adults 18-59 having qualifying conditions
- Vaccine will be available for 2025-2026 respiratory season, enabling near-term commercialization
- Common side effects reported including injection site pain, fatigue, and other reactions
- Limited to high-risk individuals in 18-59 age group, not general population
Insights
Moderna's RSV vaccine approval for at-risk adults 18-59 expands market reach, strengthening their respiratory vaccine portfolio ahead of the 2025-2026 season.
Moderna has secured an important regulatory win with the FDA's approval of mRESVIA for adults aged 18-59 at increased risk for RSV disease. This expands the eligible population beyond the initial May 2024 approval for adults 60+, potentially broadening the vaccine's commercial reach to include the estimated one-third of adults aged 18-59 with underlying conditions that increase RSV risk.
The approval is supported by compelling Phase 3 data showing that immune responses in younger at-risk adults met non-inferiority criteria compared to those in older adults. Importantly, the vaccine demonstrated consistent immunogenicity across both 18-49 and 50-59 age subgroups, suggesting reliable protection across the expanded indication.
From a market perspective, this approval positions Moderna to compete more effectively in the adult RSV vaccine market, where it faces competition from GSK's Arexvy and Pfizer's Abrysvo. The timing of this approval is strategically valuable, coming well before the 2025-2026 respiratory virus season, giving Moderna sufficient runway for production, distribution, and marketing efforts.
This approval reinforces Moderna's strategy of expanding beyond COVID-19 vaccines to build a diverse respiratory vaccine portfolio. With RSV causing significant healthcare burden and hospitalization rates in at-risk younger adults comparable to or exceeding those in older adults, this expanded indication addresses a substantial unmet medical need and opens a meaningful new revenue opportunity for the company ahead of the next respiratory season.
Expanded indication builds on existing U.S. FDA approval of mRESVIA for adults aged 60 and older
CAMBRIDGE, MA / ACCESS Newswire / June 12, 2025 / 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.
IMPORTANT SAFETY INFORMATION
Who should not get mRESVIA?
You should not get mRESVIA if you had a severe allergic reaction to any ingredient in mRESVIA.
What should you tell your healthcare provider?
Tell your healthcare provider about all of your medical conditions, including if you:
Have any allergies
Had a severe allergic reaction after receiving a previous dose of any other vaccine
Have a fever
Have a bleeding disorder or are on a blood thinner
Are immunocompromised or are on a medicine that affects your immune system
Have received any other RSV vaccine
Have ever fainted in association with an injection
How is mRESVIA given?
mRESVIA is given as an injection into the muscle.
What are the risks of mRESVIA?
There is a very small chance that mRESVIA could cause a severe allergic reaction. A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of mRESVIA. For this reason, your healthcare provider may ask you to stay for a short time at the place where you received your vaccine. Signs of a severe allergic reaction may include:
Trouble breathing
Swelling of your face and throat
A fast heartbeat
A rash all over your body
Dizziness and weakness
Side effects that have been reported in clinical trials with mRESVIA include:
Injection-site reactions: pain, underarm swelling or tenderness in the same arm of the injection, swelling (hardness), and redness
Fatigue, headache, muscle pain, joint pain, chills, nausea or vomiting, fever and hives
These may not be all of the possible side effects of mRESVIA. Ask your healthcare provider about any side effects that concern you. You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov.
Please click for mRESVIA Full Prescribing Information.
Moderna Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the efficacy, safety and tolerability of mRESVIA; the disease burden associated with RSV, particularly in adults with certain risk factors; and the availability of mRESVIA for the 2025-2026 season. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.
Moderna Contacts
Media:
Chris Ridley
Head of Global Media Relations
+1 617-800-3651
Chris.Ridley@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com
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, Inc.
View the original press release on ACCESS Newswire
FAQ
What age groups is Moderna's mRESVIA RSV vaccine now approved for?
What were the results of Moderna's Phase 3 study for mRESVIA in younger adults?
What are the common side effects of Moderna's mRESVIA vaccine?
When will Moderna's mRESVIA be available for the newly approved age group?
What percentage of adults aged 18-59 are at increased risk for severe RSV disease?
