Current ACOG/SMFM/CDC guidelines for the prevention of Group B Strep neonatal infection are aimed at prevention of early onset GBS neonatal disease. But late onset infections still occur worldwide and are devastating for the newborn. This is why there is a new Group B Strep (GBS6) vaccine in the pipeline! On September 22, 2022 the FDA granted this vaccine “Breakthrough Therapy designation”. In this session, we will review what that designation means, why this vaccine is needed, and where we are in the process.