Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Streszczenie

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The committee will discuss the biologics license application (BLA) 125768 from Pfizer, Inc. for ABRYSVO (Respiratory Syncytial Virus Vaccine) with the requested indication for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age by active immunization of pregnant individuals. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.