02.2024
Author Prof E. Harms, Münster University Children’s Hospital (Germany)
RSV infections are among the most common reasons for hospitalisation in the first year of life. A double-blind, placebo-controlled, randomised phase 3 trial conducted in 18 countries examined whether vaccinating pregnant women at 24 through 36 weeks’ gestation with a bivalent RSV prefusion F protein-based (RSVpreF) vaccine prevents their children from developing a severe RSV-associated lower respiratory tract illness during the first six months of life [1].
The study population was randomised with an allocation ratio of 1:1, whereby 3682 pregnant women received the vaccine. All RSV-associated lower respiratory tract illness of both groups (vaccine and placebo group) were recorded. The overall vaccine efficacy was 57% after 90 days and 51% after 180 days; vaccine efficacy against severe cases (hospitalisation, some in intensive care) was 82% after 90 days and 69% after 180 days.