| Drug Name |
MRESVIA™ (Respiratory Syncytial Virus Vaccine, mRNA) |
| Active Ingredient |
Respiratory Syncytial Virus Vaccine, mRNA |
| Date of Approval |
5/31/24 |
| Manufacturer |
Moderna, Inc. |
| Approval Pathways and Indications |
Approval Pathway: BLA
Indication: MRESVIA™ is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. |
| Therapeutic Class |
Vaccine, mRNA |
| Formulation |
Injectable Suspension, for Intramuscular Use |
| MoA |
MRESVIA™ induces an immune response against RSV pre-F protein that protects against LRTD caused by RSV. |
| Dosing and Administration |
For intramuscular use.
Administer a single dose (0.5 mL). |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia that causes a particularly large burden of disease in infants and adults. Every year between 60,000-160,000 older adults are hospitalized, and 6,000-10,000 die due to RSV infection. MRESVIA™ protects older adults from the severe outcomes of RSV infection.
MRESVIA™ is the first mRNA vaccine approved for a disease other than COVID-19 and 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. |
| Expected Market Launch Date |
Availability is anticipated fall of 2024. |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
FDA approval was based on the ConquerRSV study, a randomized, placebo‐controlled, observer‐blind, case‐driven clinical study (NCT05127434), that enrolled around 37,000 adults aged 60 or older across 22 countries. Participants were randomized to a single dose of MRESVIA™ or placebo (in a 1:1 ratio). Randomization was stratified by age (60 to 74 years; ≥75 years) and risk factors for LRTD, which were defined as congestive heart failure (CHF) and/or chronic obstructive pulmonary disease (COPD) at screening.
The primary endpoint analysis of the MRESVIA™ vaccine's efficacy against Respiratory Syncytial Virus-Lower Respiratory Tract Disease (RSV-LRTD) was conducted over a median follow-up period of 3.7 months. The primary efficacy endpoints were the prevention of a first episode of RSV-LRTD with either ≥2 signs/symptoms or ≥3 signs/symptoms starting 14 days after vaccination. RSV-LRTD was defined based on the following criteria: The participant must have had RT-PCR-confirmed RSV infection and experienced new or worsening of ≥2 (or ≥3) of the following signs/symptoms for at least 24 hours: shortness of breath, cough and/or fever (≥37.8°C [100.0°F]), wheezing and/or rales and/or rhonchi, sputum production, tachypnea (≥20 breaths per minute or increase of ≥2 breaths per minute from baseline measurement in those who have baseline tachypnea), hypoxemia (new oxygen saturation ≤93% or new or increasing use of supplemental oxygen), or pleuritic chest pain. If signs/symptoms could not be captured, radiologic evidence of pneumonia with RT-PCR-confirmed RSV infection was also counted as RSV-LRTD.
For RSV-LRTD with 2 or more signs/symptoms, the MRESVIA™ group reported 15 cases (0.09%) out of 17,561 participants, while the placebo group reported 70 cases (0.40%) out of 17,503 participants. This resulted in a vaccine efficacy of 78.7% (95% CI: 62.8, 87.9). For RSV-LRTD with 3 or more signs/symptoms, the MRESVIA™ group had 5 cases (0.03%) compared to 26 cases (0.15%) in the placebo group, yielding a vaccine efficacy of 80.9% (95% CI: 50.1, 92.7). |
| Sources |
1. Kilpatrick, C. (2024, June 3). US FDA approval for Moderna’s mresvia in older adults. VaccineNation. https://vaccinenation.org/technology/us-fda-approval-for-modernas-mresvia-in-older-adults/ |