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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

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  Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mRESVIA.
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  Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including mRESVIA. Procedures should be in place to avoid injury from fainting.
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  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 1-866-663-3762 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.