NOW APPROVED FOR ADULTS AGED 60 OR OLDER
The only RSV vaccine in a
pre-filled syringe (PFS)1-3
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RSV = respiratory syncytial virus.
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 adults 60 years of age and older.
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, 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%).
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.
Please click for mRESVIA Full Prescribing Information.
References
- mRESVIA Prescribing Information. ModernaTX, Inc.
- AREXVY Prescribing Information. GlaxoSmithKline Biologics SA.
- ABRYSVO Product Information. Pfizer Inc.
For Colorado and Connecticut price disclosure, please visit https://modernadirect.com/wac-disclosure
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