Status of Group B Streptococcus (GBS) for Vaccination in Pregnancy (ViP)

We are aware of two vaccines in late clinical development (Phase 2 completed) globally to address a significant medical need for pregnant women and their offspring, one from Pfizer in the United States and one from Minervax in Denmark. Here is a summary Pfizer GBS6 maternal vaccinePfizer’s GBS6 vaccine is a hexavalent capsular polysaccharide–protein conjugate that includes purified capsular polysaccharides from serotypes Ia, Ib, II, III, IV, and V of Streptococcus agalactiae, each individually conjugated to the CRM197 mutant diphtheria toxin carrier protein, formulated in a histidine buffer with polysorbate 80, sodium chloride and optionally aluminum phosphate as adjuvant. Status: A global phase 3 trial of Pfizer’s hexavalent polysaccharide‑conjugate GBS vaccine (GBS6) in pregnant women has been initiated. Trial: BEATRIX, a randomized, placebo‑controlled, double‑blind phase 3 study evaluating safety, tolerability and immunogenicity of multivalent GBS6 in pregnant participants with infant follow‑up (ClinicalTrials.gov NCT07160244). When: Regulatory and public announcements in mid‑2025; trial listing shows phase...