Bharat Biotech Leads GSK Shigella Vaccine Phase 3 Development

Bharat Biotech International Limited has partnered with GSK plc to advance the development of the Shigella vaccine candidate altSonflex1-2-3, targeting Shigellosis—a severe bacterial diarrhoea primarily affecting children under five in low- and middle-income countries. The vaccine has shown a favorable safety profile and strong immune response in early Phase 1 trials in Europe and Phase 2 trials in Africa, including in the primary target population of 9-month-old infants, with no safety concerns reported. Bharat Biotech will lead Phase 3 clinical trials, regulatory processes, and large-scale manufacturing, while GSK will support clinical trial design, funding, access, and commercialization strategies. The vaccine utilizes an innovative GMMA platform, allowing cost-effective production and broad serotype coverage, addressing the urgent need for a scalable and affordable solution amid rising antimicrobial resistance. This collaboration reflects a critical effort to develop the first licensed Shigella vaccine and improve global health equity by reducing illness and antibiotic use in vulnerable populations. Both companies emphasize the vaccine's potential to combat antimicrobial resistance and save lives worldwide.