Canada Approves RSV Antibody for Children

Health Canada today announced it had issued a Notice of Compliance approving BEYFORTUS™ (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants during their first RSV season.

And children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

BEYFORTUS is not a vaccine.

It is an immunizing agent and a long-acting monoclonal antibody (mAB).

The approval on April 24, 2023, was based upon a BEYFORTUS™ clinical development program spanning three pivotal late-stage clinical trials.

Jason Lee, Head of Vaccines Medical Affairs, Sanofi Canada, commented in a press release, "Today is a historical day for RSV prevention as decades of research and development culminate in Canada's approval of the first immunization against RSV disease."

"BEYFORTUS, designed using a long-acting mAB, will help meet a vast unmet need in RSV prevention, providing parents with an option to protect their infants during the first RSV season."

Sanofi stated it is committed to making BEYFORTUS available to newborns and infants for the upcoming 2023/2024 RSV season. 

In the U.S., government agencies are reviewing this mAB for potential authorization this year.

The U.S. Food and Drug Administration (FDA) approved an injectable mAB therapy (Synagis®) in 1998.

RSV is a common and highly contagious seasonal respiratory virus infecting almost all children. It is a leading cause of infant hospitalizations (79%), including infants born at term with no underlying health conditions.

RSV also burdens the health system, with most hospitalized infants needing supplemental oxygen and some requiring ICU admission.

RSV vaccine candidates remain under review in the U.S. and have not been U.S. FDA-approved.