83% reduction in RSV infant hospitalizations with Nirssevimab

83.21% reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention shown in the Phase 3b clinical trial from HARMONIE.

The Hospitalized RSV Monoclonal Antibody Prevention study is a large clinical trial aiming to determine the efficacy and safety of a single intramuscular dose of nirsevimab, with data collected in a real-world setting during the 2022-2023 RSV season. The trial recruited more than 8,000 infants and took place at nearly 250 sites across France, Germany and the United Kingdom. The data from HARMONIE were presented at the 41^st Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID).

Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“This winter saw higher rates of RSV-related infant hospitalizations than during pandemic or pre-pandemic years. The HARMONIE data demonstrate the real-world impact nirsevimab has on pediatric hospitalizations, and illustrate its importance for infants, their families and public health.”

Dr Simon Drysdale
Consultant Pediatrician in Infectious Diseases at St. George’s University Hospital NHS Foundation Trust and Co-Chief Investigator of HARMONIE
“RSV-related chest infections lead to high numbers of infants under 12 months old being hospitalized every year. These data reinforce the potential public health benefit of nirsevimab in terms of helping to reduce the strain on hospitals caused each year by RSV.”

The data from HARMONIE also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD by 75.71% (95% CI 32.75 to 92.91; P<0.001).

Additionally, nirsevimab demonstrated a reduction of 58.04% in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention. This means the overall burden on healthcare systems could be reduced significantly if all infants receive nirsevimab. RSV-related direct medical costs, globally — including hospital, outpatient and follow-up care were estimated at €4.82 billion in 2017.

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Related Topics and Keywords

clinical trial, harmonie, nirsevimab, rsv, rsv disease