Moderna, Inc. (NASDAQ: MRNA) announced today that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine designed to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. This approval, granted under a breakthrough therapy designation, marks the second approved mRNA product from Moderna.
“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, Chief Executive Officer of Moderna. “mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors. This marks the first time an mRNA vaccine has received approval for a disease other than COVID-19.With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.”
What is RSV and Why is it Important?
RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. It poses a significant health risk, particularly to infants and older adults. In the U.S., RSV infection hospitalizes approximately 60,000-160,000 older adults and causes 6,000-10,000 deaths each year.
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, essential for viral infection, serves as a significant target for potent neutralizing antibodies. It remains highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as Moderna’s COVID-19 vaccines.
Clinical Trial Data
The FDA’s approval of mRESVIA is based on positive data from the Phase 3 clinical trial ConquerRSV, which included approximately 37,000 adults aged 60 years or older from 22 countries. The primary analysis, with a median follow-up of 3.7 months, found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). These results were published in The New England Journal of Medicine. A follow-up analysis performed during the FDA review confirmed consistent results with a vaccine efficacy of 78.7% (CI 62.9%, 87.8%) and included in the U.S. package insert. An additional longer-term analysis showed continued protection against RSV LRTD over a median follow-up of 8.6 months.
Safety Profile
No serious safety concerns were identified in the Phase 3 trial. The most commonly reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.
Availability
Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season. Additionally, Moderna has filed for mRNA-1345 approval with regulators in multiple markets worldwide.
Indication
mRESVIA® is indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 years of age and older.
Important Safety Information
Contraindications:
Do not administer mRESVIA to individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.
Warnings and Precautions:
- Management of Acute Allergic Reactions: Ensure appropriate medical treatment is available to manage potential anaphylactic reactions following administration of mRESVIA.
- Syncope: Fainting may occur following vaccine administration; procedures should be in place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised individuals may have a diminished immune response to mRESVIA.
Adverse Reactions:
The most commonly reported adverse reactions in clinical trials (≥10%) were injection-site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (25.6%), arthralgia (21.7%), axillary (underarm) swelling or tenderness (15.2%), and chills (11.6%).
To report suspected adverse reactions, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Forward-Looking Statements
This announcement includes forward-looking statements that involve risks and uncertainties, including those described under “Risk Factors” in Moderna’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and subsequent filings with the SEC. These statements are based on current expectations and speak only as of the date of this announcement. Moderna disclaims any intention or responsibility for updating forward-looking statements as new information becomes available.
For more information, please visit Moderna’s official website.