Group B Streptococcus or Streptococcus agalactiae is an encapsulated Gram-positive coccus capable of producing a wide range of disease outcomes in humans of all ages. In the neonate, the bacterium is a leading cause of severe life-threatening sepsis, meningitis, and pneumonia (early-onset, EOGBS and late-onset LOGBS disease). GBS is vertically transmitted from the birth canal of colonized females (~18-30% of total) and transmitted during labour. GBS may also contribute to stillbirth, pre-mature birth, neonatal encephalopathy, and long-term neurological outcomes in meningitis survivors. It can cause perinatal clinical syndromes in the mother during pregnancy such as maternal sepsis and chorioamnionitis. Globally, GBS has substantial healthcare impact and in 2021 is estimated to have caused 394,000 cases of invasive neonatal disease resulting in 91,900 deaths (95% CI 44,800-187,800) (Goncalves BP et al 2022).
A prophylactic Group B Streptococcus vaccine is considered a high priority by the World Health Organization which has conducted several analyses to support the development case (WHO Full Value Assessment, 2021). The ideal GBS vaccine could ‘plug the gaps’ in current screening + IAP* strategies (where present) and reduce further the impact of GBS invasive disease (iGBS)/outcomes in several target populations both in Western developed countries and the developing world e.g., GAVI-assisted countries. A vaccine could also occur limit antibiotic exposure, consumption and lessen the likelihood of global resistance.
Several GBS vaccine approaches are ongoing in both preclinical and clinical development with the most advanced being the Pfizer, GBS6 vaccine [PF-06760805], a hexavalent polysaccharide conjugated approach (serotypes Ia, Ib, II, III, IV, and V) which recently reported positive data from an ongoing Phase 2 study [NCT03765073]. Importantly, Pfizer have also a conducted parallel seroepidemiological study in 18,000 mother-infant pairs in South Africa, seeking to establish IgG thresholds that are associated with risk reduction of GBS disease. This could establish an immune correlate of efficacy for their vaccine and avoid a large Phase 3 field efficacy study. Danish-based MinervaX ApS are also developing an adjuvanted protein-based GBS vaccine (GBS-NN, GBS-NN2) for maternal (Phase 2) and adult indications (Phase 1). Other earlier potential approaches are being pursued by Nanjing Agricultural University, China, and the US-biotech, Omniose.
VacZine Analytics’ MarketVIEW: Group B Streptococcus vaccines is a brand-new comprehensive Executive Presentation (>320 slides, .pdf) and interactive MS-Excel forecast model (155 worksheets, .xls) which investigate the commercial potential of Group B Streptococcus vaccines across key target groups (maternal, at risk, elderly) in 118 nations (public/private) worldwide including HI income and GAVI/developing world countries. The analysis includes a thorough review of latest disease background/epidemiology/resistance trends data along with discussion of latest understanding of vaccinology/R&D competitor landscape. A scenario-based commercial assessment of potential GBS vaccine profiles is presented with discussion around target population rationale, potential uptake, pricing, cost-effectiveness, and clinical development feasibility/issues. This MarketVIEW product would ideally suit both developers of GBS vaccines and those wishing an advanced appraisal of this important field.
*Intrapartum Antibiotic Prophylaxis (IAP)
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