Drug updated on 12/11/2024
Dosage Form | Injection (intramuscular; 0.5 mL) |
Drug Class | Vaccines |
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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Mresvia (Respiratory Syncytial Virus Vaccine) Prescribing Information. | 2024 | Moderna US, Inc., 5 Vaughn Drive Princeton, NJ |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults | 35,413Subjects F: 49% M: 51% | 2023 | The New England Journal of Medicine |
Sex Distribution:
F:49%
M:51%
35413Subjects
Year:
2023
Source:The New England Journal of Medicine
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Use of Respiratory Syncytial Virus Vaccines in Adults Aged ≥60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. | 2024 | Morbidity and Mortality Weekly Report |