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Indication Update: mRESVIA® (Respiratory Syncytial Virus Vaccine)

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Indication Update: mRESVIA®

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Adults with certain medical conditions are at increased risk for severe RSV. 1† Help protect more patients with mRESVIA.1

mRESVIA® Is Now Indicated for the Following Individuals1:

18 through 59 years of age
who are at increased risk† for LRTD caused by RSV
60 years of age and older

*Stored frozen between -40 °C to -15 °C (-40 °F to 5 °F), with the option to thaw at refrigeration or room temperature. A carton of 2 pre-filled syringes can be thawed at refrigeration 2 °C to 8 °C (36 °F to 46 °F) for 100 minutes or at room temperature 15 °C to 25 °C (59 °F to 77 °F) for 40 minutes. A carton of 10 pre-filled syringes can be thawed at refrigeration 2 °C to 8 °C (36 °F to 46 °F) for 160 minutes or at room temperature 15 °C to 25 °C (59 °F to 77 °F) for 80 minutes.1

† Increased risk was defined as documented confirmation of at least one of the following conditions: CAD and/or CHF, chronic lung disease (including but not limited to COPD or persistent asthma), and Type 1 or Type 2 DM.1

Indication

mRESVIA (Respiratory Syncytial Virus Vaccine) 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 and individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

Important Safety Information

Contraindications

Do not administer mRESVIA to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of mRESVIA.

Warnings and Precautions

  • Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mRESVIA.
  • Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including mRESVIA. Procedures should be in place to avoid injury from fainting.
  • Altered Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to mRESVIA.

Adverse Reactions

In a clinical trial conducted in participants 60 years of age and older, the most commonly reported (≥10%) adverse reactions 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%).

In a clinical trial conducted in participants 18 through 59 years of age at increased risk for LRTD caused by RSV, the most commonly reported (≥10%) adverse reactions were injection site pain (73.9%), fatigue (36.9%), headache (33.3%), myalgia (28.9%), arthralgia (22.7%), chills (19.9%), axillary (underarm) swelling or tenderness (17.1%), and nausea/vomiting (10.8%).

To report suspected adverse reactions, contact ModernaTX, Inc. at 1-8‍00-8‍22-79‍67 or VAERS at 1-8‍00-8‍22-7‍96‍7 or https://vaers.hhs.gov/.

Please click for mRESVIA Full Prescribing Information.

Click here for more information on mRESVIA® Product and Reimbursement.

For Colorado and Connecticut price disclosure, please visit https://modernadirect.com/wac-disclosure.

CAD, coronary artery disease; CHF, chronic heart failure; COPD, chronic obstructive pulmonary disease; DM, diabetes mellitus; LRTD, lower respiratory tract disease; RSV, respiratory syncytial virus.

References: 1. mRESVIA Prescribing Information. Moderna; 2025. 2. AREXVY Prescribing Information. GlaxoSmithKline Biologics SA 3. ABRYSVO Product Information. Pfizer Inc.