In a groundbreaking development, a global trial known as HARMONIE has demonstrated the potential to significantly decrease hospitalizations among infants by up to 80% through the use of a novel antibody treatment. The trial, conducted collaboratively by the National Institute for Health and Care Research (NIHR), Sanofi, and AstraZeneca, involved 8,058 infants under the age of 12 months from the UK, France, and Germany, all approaching their first Respiratory Syncytial Virus (RSV) season.
RSV stands as the primary cause of infant hospitalization, exerting substantial pressure on NHS resources. Annually, more than 30,000 children under the age of five are hospitalized due to RSV, leading to over 20 to 30 infant deaths, often attributed to severe respiratory issues like bronchiolitis and pneumonia.
Dr. Matthew Hallsworth, NIHR Director of Strategic Industry Relationships, hailed the HARMONIE trial as a stellar example of collaboration between industry and NIHR. He emphasized NIHR’s pivotal role in executing the study across secondary and primary care settings, showcasing the effectiveness of the collaboration.
The trial’s findings indicate that immediate protection against RSV can be achieved with a single dose of the nirsevimab antibody, potentially reducing RSV-related infant hospitalizations by an impressive 83%. This breakthrough has the potential to alleviate the strain on NHS resources during the winter period. Approval for the treatment has already been secured in the UK, with considerations for its inclusion in a national immunization program.
Professor Saul Faust, Director of NIHR Southampton Clinical Research Facility and co-leader of the study, underscored the significance of these results. He highlighted the safety of the long-acting antibody and its potential to protect a significant number of infants from hospitalization under conditions mirroring routine clinical practice. The findings are deemed crucial for informing future decisions regarding the implementation of a national RSV immunization program in the UK.
