FDA approves RSV monoclonal antibody for infants, young children at high risk
The Food and Drug Administration approved a monoclonal antibody to protect infants and young children from severe illness caused by RSV on Monday, a potential game-changer for a disease that is the No. 1 cause of hospitalization of babies in this country.
Use of the antibody treatment, the brand name for which is Beyfortus, still needs to be recommended by the Advisory Committee on Immunization Practices, an independent expert panel that advises the Centers for Disease Control and Prevention. A special meeting of the ACIP has been set for Aug. 3 to vote on whether to recommend the antibody, and on whether to add it to the Vaccines for Children program, which would require the federal government to pay for it for children without health insurance.
