AstraZeneca (AZ) and Sanofi have shared new positive real-world data for Beyfortus (nirsevimab) in infant respiratory syncytial virus (RSV) from an ongoing study published in The Lancet.
As part of the three-year NIRSE-GAL study, the new results echo real-world evidence from several broad immunisation programmes across the US, Spain and France during the 2023 to 2024 RSV season.
Currently the most-leading cause of hospitalisation in infants worldwide, RSV is a highly contagious virus that is the most common cause of lower respiratory tract disease in infants, with most RSV hospitalisations occurring in healthy infants born at term.
Running from September 2023 to March 2024, the study has been measuring the impact of Beyfortus on RSV hospitalisations among infants born during the RSV season, infants aged under six months at the beginning of the season and children aged six to 24 months who were vulnerable to severe RSV disease at the start of the season.
The study demonstrated that Beyfortus reduced RSV hospitalisations in infants aged under six months by 82% during the 2023 to 2024 RSV season, compared to infants who received no RSV intervention.
In addition, the treatment demonstrated a favourable safety profile, which is consistent with clinical study results.
Earlier this year, in January, AZ and Sanofi shared positive results from the HARMONIE trial, which demonstrated that Beyfortus could significantly reduce hospitalisations in infants under the age of 12 months.
Thomas Triomphe, executive vice president, vaccines, Sanofi, commented: “A growing body of evidence from these programmes support policymakers, healthcare providers and parents who share our collective ambition to safeguard babies from RSV disease.”
Designed to bind the fusion protein on the surface of the RSV virus, the human monoclonal antibody injection previously received approval from the European Commission and the US Food and Drug Administration to treat newborns and infants during their first RSV season.
The ongoing expansion of Beyfortus’ manufacturing network will allow AZ and Sanofi to triple manufacturing capacity to meet global commitments and both companies aim to produce the RSV treatment in advance of the RSV season, with the majority of doses planned to be available by October 2024.