Providing nirsevimab (Beyfortus) to all newborns and high-risk infants during the 2024-2025 RSV season represents an advancement in protecting infant health.
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The Ontario Ministry of Health has introduced a universal public health program, providing Beyfortus (nirsevimab) to all newborns and infants born in 2024, as well as high-risk children up to 24 months old, throughout the 2024-2025 RSV season. This initiative marks Ontario's first publicly funded, broad-based infant protection program against Respiratory Syncytial Virus (RSV), a common respiratory pathogen that can cause severe lung infections like bronchiolitis and pneumonia.1
The National Advisory Committee on Immunization (NACI) recommended a universal RSV immunization program with nirsevimab due to the significant burden of RSV on infants and the healthcare system. NACI highlighted that almost all children are infected with RSV by age two, with severe cases often occurring in previously healthy infants. A recent study published in The Lancet found that 80% of hospitalized infants with RSV were healthy and born at term.1
Sanofi reported that nirsevimab reduced hospitalizations for infants under 6 months old by 82% compared to those who did not receive RSV intervention. These interim results, from the first RSV season after nirsevimab's introduction, are part of the ongoing NIRSE-GAL study. 2
The interim analysis included data from September 25 to December 31, 2023, involving infants born up to December 15, 2023. Out of 10,259 eligible infants, 9,408 received nirsevimab, 6,220 in the seasonal group, and 3,188 in the catch-up group. In the high-risk group, 360 participants were offered nirsevimab, with 348 receiving the immunization. The study focused on the seasonal and catch-up groups due to insufficient events in the high-risk group.3
In total, 30 of 9,408 infants who received nirsevimab and 16 (1.9%) of 851 who did not receive it were hospitalized for RSV-related lower respiratory tract infections (LRTIs).3
Delphine Lansac, General Manager of Vaccines at Sanofi Canada, highlighted the importance of the program, stating, "Providing universal access to Beyfortus means parents can focus on their new baby without worrying about severe RSV infections. This program aligns with Sanofi's long-standing commitment to public health and aims to significantly benefit families and the healthcare system."1
In July 2023, the US FDA approved Sanofi and AstraZeneca’s nirsevimab for the prevention of RSV LRTD in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.4
Nirsevimab received a Notice of Compliance from Health Canada in April 2023 and has been approved by the FDA and the European Union. It offers a single-dose, long-acting antibody designed to prevent RSV lower respiratory tract disease during an infant’s first RSV season, with protection lasting at least five months.
Overall, Ontario’s new RSV protection program, offering nirsevimab to all newborns and high-risk infants, aims to significantly reduce severe RSV cases during the 2024-2025 season. With interim study results showing an 82% reduction in hospitalizations, this initiative should improve infant health outcomes and ease the burden on the healthcare system.
