Efficacy for mRESVIA® (Respiratory Syncytial Virus Vaccine)

In a clinical trial, mRESVIA was proven to protect adults aged 60 or older against RSV, regardless of comorbidities.¹*

Primary analyses (3.7 months median follow-up):

81%

effective against RSV-LRTD with ≥3 signs/symptoms

(95% CI: 50.1-92.7)^1†‡

79% effective against RSV-LRTD with ≥2 signs/
symptoms (95% CI: 62.8-87.9)^1†§

mRESVIA clinical trial design¹

mRESVIA was evaluated in a large study of diverse older adults.¹ This randomized, placebo-controlled, observer-blind, case-driven clinical study evaluated the safety and efficacy of a single dose of mRESVIA (0.5 mL) to prevent RSV-LRTD in adults aged 60 or older, with or without underlying medical conditions, for up to 24 months following vaccination. Participants were randomized in a 1:1 ratio to mRESVIA or placebo. The primary efficacy endpoints were the prevention of a first episode of RSV-LRTD with ≥2 or ≥3 signs or symptoms starting 14 days after vaccination.^1||

36,412

adults from 22
different countries¹

10,609

adults had ≥1
preexisting
comorbidity¹*

*Comorbidities included chronic cardiopulmonary conditions, including congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD), asthma, and other chronic respiratory conditions as well as diabetes, advanced liver disease, and advanced kidney disease.¹

^†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 at least 2 or more (or 3 or more) 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.¹

^‡Five out of 17,561 cases with mRESVIA vs 26 out of 17,503 cases with placebo.¹

^§Fifteen out of 17,561 cases with mRESVIA vs 70 out of 17,503 cases with placebo.¹

^||The primary efficacy analysis population included 35,064 participants who received either mRESVIA (n=17,561) or placebo (n=17,503). Randomization was stratified by age and risk factors for LRTD.¹

CI = confidence interval; RSV = respiratory syncytial virus; RSV-LRTD = respiratory syncytial virus–associated lower respiratory tract disease.

Indication and Important Safety Information

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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