RSV Antibody for Infants Preps for Launch

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) is meeting on August 3, 2023, regarding the proposed recommendation for Beyfortus™ (Nirsevimab-alip), the first approved extended half-life monoclonal antibody (mAB) offering passive immunization to prevent lower respiratory tract infections (LRTI) caused by the respiratory syncytial virus (RSV). 

This ACIP meeting draft agenda, from 11:00 am – 3:30 pm EDT, includes presentations on Feasibility/implementation plans for monitoring the safety and effectiveness of this RSV prevention drug and second-season clinical considerations.

The webcast link for this open-to-the-public digital meeting is here.

John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, commented on July 17, 2023, “Today’s approval (Beyfortus) addresses the great need for products to help reduce the impact of RSV disease on children, families, and the health care system.”

The FDA previously approved the Synagis® (Palivizumab) RSV mAb in 1998.

RSV is a virus that causes acute respiratory infection in individuals of all age groups. While most infants and young children experience mild, cold-like symptoms, some infants, especially with their first infection. RSV is transmitted from person to person through close contact with someone who is infected.

In most parts of the U.S., RSV circulation is seasonal, typically starting in Florida during the fall and peaking in the winter.