Why is this important?
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If approved for sale, RSVPreF3 OA will be the first prophylactic therapy and first vaccine to receive licensing for older adults at risk of having exacerbations of other illnesses, being hospitalized or dying from RSV infection.
Principle results
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24,966 participants received 1 dose of RSVPreF3 OA vaccine (n=12,467) or placebo (n=12,499).
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The mean age was 69.5 years, and approximately 39% of participants in each group had comorbidities known to be associated with an increased risk of serious RSV infection (eg, chronic obstructive pulmonary disease [BPCO]asthma, any chronic respiratory or lung disease, chronic heart failure, type 1 or 2 diabetes, or advanced liver or kidney disease).
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RSV vaccine efficacy in participants with confirmed RSV (exposed population) followed for a median of 6.9 months was 82.6%.
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Vaccine efficacy once morest RSV-related severe lower respiratory tract disease was 94.1% (1 case in vaccine group, 17 in placebo group) and 71.7% once morest RSV-related acute respiratory infections. RSV.
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Vaccine efficacy once morest RSV subtypes A and B was similar.
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Overall, most adverse events were mild to moderate in severity.
Methodology
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An ongoing Phase III, placebo-controlled study evaluated the efficacy of the single-dose RSVPreF3 OA vaccine once morest RSV-related lower respiratory tract disease in adults (aged 60 years or older) in Africa, South America, North, Asia, Australia and Europe.
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Financement : GlaxoSmithKline Biologicals.
Limits
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Low proportion of participants who are frail or aged 80 or over.
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Public health measures to limit COVID-19 have also limited RSV transmission and altered seasonal occurrence.
