Sanofi Launches Beyfortus, an Antibody Injection for RSV Prevention

Infants and Young Children: The Highest Risk Group for RSV

'Beyfortus,' a respiratory syncytial virus (RSV) preventive antibody injection for all newborns and infants, has been launched.

Sanofi Korea announced on the 6th that Beyfortus, which received approval from the Ministry of Food and Drug Safety (MFDS) in April last year, entered the domestic prescription market starting the day before. Beyfortus can be administered at major hospitals and clinics nationwide.

RSV is a highly contagious virus infecting 90% of children under the age of two. Especially when infants contract RSV, symptoms can worsen into bronchiolitis and pneumonia, requiring hospitalization. Since there is currently no treatment for RSV, the importance of prevention is drawing attention.

Preventive antibody injections differ from vaccines in that antibodies targeting the virus or other antigens are directly injected into the body, allowing antibodies and antigens to fight. The effect appears immediately but lasts only a few months, which is a limitation. They are mainly used when immediate effect is needed, such as for newborns and high-risk groups. Vaccines take several weeks to show effects but provide protection for several years.

Beyfortus is a preventive antibody injection that can be administered to all infants experiencing their first RSV season (October to March) after birth. It is characterized by being available to all newborns and infants during the season regardless of underlying conditions. Existing RSV preventive antibody injections were only available for infants such as preterm babies and those with congenital heart disease.

Currently, Beyfortus demonstrates RSV preventive efficacy through real-world evidence consistent with the phase 3 clinical trial results that served as the basis for its approval. Notably, Galicia, Spain, which was the first in the world to introduce Beyfortus into its national immunization program, has been conducting a longitudinal study since September 2023, closely monitoring infants who received Beyfortus. According to an interim analysis published in the medical journal 'The Lancet' in May last year, hospitalization due to RSV in infants under six months who received Beyfortus decreased by 82% compared to those who did not receive it. This study will continue for a total of three years until October 2026.

Park Hee-kyung, head of Sanofi’s vaccine business division, said, "Given the current nationwide RSV outbreak, we hope that the launch of Beyfortus will allow infants at high risk of RSV infection to benefit from RSV prevention." She added, "Since Beyfortus has significantly reduced RSV-related hospitalizations overseas, it is expected to contribute to reducing the burden on families with infants in Korea as well."

This content was produced with the assistance of AI translation services.