Universal Immunization Program for Infants During Ontario's RSV Season

The Ontario Ministry of Health has announced the first publicly funded universal program with Beyfortus® (nirsevimab) for all newborns and infants born in 2024 and through the 2024-2025 respiratory syncytial virus (RSV) season in the Northern Hemisphere.

Beyfortus single-dose administration can be timed to the start of the RSV season.

RSV is a common respiratory virus that often impacts children and can lead to lung infections such as bronchiolitis and pneumonia.

As of July 25, 2024, this new passive immunization program also includes some high-risk children up to 24 months old.

Beyfortus is administered directly to newborns and infants and offers rapid protection via an antibody without requiring immune system activation.

Delphine Lansac, General Manager, Vaccines, Sanofi Canada. commented in a press release on July 25, 2024, "Today's announcement by the Government of Ontario is a significant milestone. Providing universal access to Beyfortus® to help protect all infants in Ontario means that parents can focus on the joys of a new baby and worry less about experiencing a severe RSV infection."

"This new program builds on our 110-year heritage as a committed partner supporting public health in Canada. Our objective continues to be protecting the health of Canadians with innovative solutions and introducing Beyfortus® is a step forward to protect babies and make a positive difference for families and the healthcare system."

Health Canada issued a Notice of Compliance for Beyfortus in April 2023. Additionally, the single-dose, extended half-life monoclonal antibody was approved by the U.S. FDA in July 2023 and the European Union in October 2022.

According to media reports, access to Beyfortus is expected to meet demand in the United States during the second half of 2024.

AstraZeneca, responsible for Beyfortus manufacturing, confirmed regulatory applications for two additional filling lines have been submitted to health authorities to expand supply. This production expansion is anticipated to augment capacity compared to the one licensed line.