China Approves RSV Passive Immunization for Children

AstraZeneca and Sanofi recently announced China's National Medical Products Administration approved Beyfortus™ (Nirsevimab-alip) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI).

Beyfortus is the first approved single-dose (50mg) preventive option to protect infants born healthy at term, preterm, or with specific health conditions that make them vulnerable to severe RSV disease entering or during their first RSV season.

Beyfortus is anticipated to be available in China during the upcoming 2024-2025 RSV season. Its administration can be timed to the start of the local RSV season.

RSV is the most common cause of LRTD in infants, including bronchiolitis and pneumonia, and is also a leading cause of hospitalisation in all infants. China ranks among countries with a high prevalence of RSV infections.

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, commented in a press release on January 2, 2024, "Beyfortus  represents the first opportunity to prevent serious respiratory disease due to RSV for all infants in China."

"We look forward to making Beyfortus available for the 2024/25 season."

While Beyfortus was approved in the United States in 2023, its availability has been limited. As of December 14, 2023, the manufacturers committed 1.4 million doses for delivery in the U.S. before February 2024.

Canada, the European Union, and the United Kingdom have also approved Beyfortus.