Mrna Vaccines List : Based RSV Vaccine’s Safety and Efficacy
mRNA-Based RSV PreF Vaccine’s Safety and Efficacy in Older Adults
Background information in abstract
In older adults, respiratory syncytial virus (RSV) can result in significant morbidity and mortality. Clinical research is being done on mRNA-1345, an mRNA-based RSV vaccine that encodes the stabilized RSV prefusion F glycoprotein.
METHODS
In this continuous phase 2-3 randomized, double-blind, placebo-controlled study, participants 60 years of age or older were assigned at random, 1:1 ratio, to receive one dose of mRNA-1345 (50 μg) or placebo.
The prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms were the two main efficacy end points.
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The avoidance of acute respiratory disease linked with RSV was a crucial secondary efficacy objective. Safety was evaluated as well.
OUTCOMES
A total of 35,541 individuals were randomized to receive either a placebo (17,748) or the mRNA-1345 vaccine (17,793 participants).
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112 days was the median follow-up period (range: 1 to 379). When at least 50% of the predicted cases of RSV-associated lower respiratory tract disease had materialized, the primary analyses were carried out.
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The effectiveness of the vaccine against RSV-associated lower respiratory tract disease with at least two signs or symptoms was 83.
7% (95.88% confidence interval [CI], 66.0 to 92.2), while the efficacy against the disease with at least three signs or symptoms was 82.4% (96.36% CI, 34.8 to 95.3).
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68.4% (95% CI, 50.9 to 79.7) of the vaccine prevented acute respiratory illness linked to RSV. There was protection against both RSVs.
subgroups based on age and coexisting conditions, and was largely consistent between subtypes (A and B). The incidence of solicited local adverse reactions (58.7% vs. 16.2%) and systemic adverse reactions (47.7% vs.
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32.9%) was higher in the mRNA-1345 group than in the placebo group; the majority of reactions were mild to moderate in severity and were temporary. In each trial group, 2.8% of participants experienced serious adverse events.
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RESULTS
Among adults 60 years of age or older, a single dose of the mRNA-1345 vaccine produced no obvious safety concerns and reduced the incidence of RSV-associated acute respiratory illness and lower respiratory tract disease compared to placebo.
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