Respiratory Syncytial Virus Vaccine

(Mresvia®)

Mresvia®

Drug updated on 12/11/2024

Dosage FormInjection (intramuscular; 0.5 mL)
Drug ClassVaccines
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.

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Summary
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  • This summary is based on the review of one randomized controlled trial. [1]
  • The mRNA-1345 vaccine showed significant efficacy in preventing RSV-associated lower respiratory tract disease (LRTD) with at least two signs or symptoms, with a vaccine efficacy of 83.7% (95.88% confidence interval (CI), 66.0 to 92.2). For respiratory syncytial virus (RSV)-associated LRTD with at least three signs or symptoms, the vaccine efficacy was 82.4% (96.36% CI, 34.8 to 95.3).
  • The vaccine demonstrated an efficacy of 68.4% (95% CI, 50.9 to 79.7) in preventing RSV-associated acute respiratory disease. Protection was consistent across RSV subtypes (A and B) and subgroups defined by age and coexisting conditions, showing broad applicability in adults aged 60 years or older.
  • In the mRNA-1345 group, 58.7% of participants experienced local adverse reactions, compared to 16.2% in the placebo group. Systemic adverse reactions were reported in 47.7% of the mRNA-1345 group and 32.9% of the placebo group. Most reactions were mild to moderate in severity and transient.
  • Serious adverse events occurred in 2.8% of participants in both the mRNA-1345 and placebo groups, with no notable safety concerns identified.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Mresvia (Respiratory Syncytial Virus Vaccine) Prescribing Information.2024Moderna US, Inc., 5 Vaughn Drive Princeton, NJ

Randomized Controlled Trials

Document TitleSex DistributionYearSource
Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults
35,413Subjects
F: 49%
M: 51%
2023The New England Journal of Medicine

Sex Distribution:

F:49%
M:51%
35413Subjects

Year:

2023

Source:The New England Journal of Medicine

Clinical Practice Guidelines