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Nirsevimab is a long-acting antibody designed for all infants for protection against RSV disease from birth through their first RSV season with a single dose, is being developed jointly by Sanofi and AstraZeneca. Nirsevimab has been developed to offer newborns and infants direct RSV protection via an antibody to help prevent medically attended lower respiratory tract infections caused by RSV.

RSV virion/CDC

On Friday, Sanofi announced new data from the Hospitalized RSV Monoclonal Antibody Prevention (HARMONIE) Phase 3b clinical trial showing an 83.21% reduction in hospitalizations due to (RSV)-related lower respiratory tract disease (LRTD) in infants under 12 months of age who received a single dose of nirsevimab, compared to infants who received no RSV intervention.

The data also show that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD (patients whose oxygen level is under 90% and require oxygen supplementation) by 75.71%. Lastly, nirsevimab demonstrated a reduction of 58.04% in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention.

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Thomas Triomphe, Executive Vice President, Vaccines, Sanofi said, “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.”

RSV, a common and highly contagious seasonal virus, infects nearly all infants and young children by the age of two. In 2019 there were approximately 33 million cases globally leading to more than three million hospitalizations and it was estimated that there were 26,300 in-hospital deaths of children younger than five years.