Approaches to Support Streptococcal Vaccine Licensure & Adoption (125806)
Streptococcal diseases pose a significant challenge to global public health, resulting in hundreds of millions of infections annually across all age groups. Although effective vaccines exist for Streptococcus pneumoniae, a considerable disease burden remains due to limited vaccine accessibility and the need for protection against a broader range of serotypes. In contrast, there are currently no vaccines available anywhere to help prevent Group B Streptococcal (GBS) infections. This presentation will explore the advancements toward the potential licensure of Pfizer’s investigational six-valent polysaccharide conjugate vaccine (GBS6) aimed at safeguarding newborns from GBS disease by administering it to pregnant women. Due to the relatively low incidence of GBS disease, efficacy studies are lengthy, costly, and operationally complex compared to previous maternal vaccine trials, such as those for respiratory syncytial virus. The GBS6 vaccine candidate is slated for evaluation in an upcoming global Phase 3 study, along with planned post-licensure effectiveness studies