Moderna Receives U.S. FDA Approval for RSV Vaccine, mRESVIA, in Adults Aged 18–59 at Increased Risk for RSV Disease

Rhea-AI Summary

Moderna (NASDAQ:MRNA) has received FDA approval for mRESVIA (mRNA-1345), its RSV vaccine, for adults aged 18-59 who are at increased risk for RSV disease. This expands the previous approval from May 2024 for adults 60 and older. The approval is based on Phase 3 study results showing comparable immune responses to those in older adults. Over one-third of adults aged 18-59 have underlying conditions putting them at increased risk of severe RSV disease. The vaccine demonstrated consistent immunogenicity across age subgroups and was generally well-tolerated, with common side effects including injection site pain, fatigue, headache, myalgia, and arthralgia. Moderna plans to make mRESVIA available for both age groups during the 2025-2026 respiratory virus season.

Positive

• 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

Negative

• 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

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?

mRESVIA is now approved for adults aged 18-59 who are at increased risk for RSV disease, as well as all adults aged 60 and older.

What were the results of Moderna's Phase 3 study for mRESVIA in younger adults?

The Phase 3 study showed that immune responses in adults 18-59 met non-inferiority criteria compared to older adults, with comparable neutralizing antibodies across 18-49 and 50-59 age subgroups.

What are the common side effects of Moderna's mRESVIA vaccine?

The most commonly reported side effects were injection site pain, fatigue, headache, myalgia and arthralgia.

When will Moderna's mRESVIA be available for the newly approved age group?

Moderna plans to make mRESVIA available for both younger at-risk adults (18-59) and older adults (60+) during the 2025-2026 respiratory virus season.

What percentage of adults aged 18-59 are at increased risk for severe RSV disease?

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.