Bharat Biotech International Limited (BBIL) has entered into a licensing agreement with GSK plc to take over the development of altSonflex1‑2‑3, GSK’s promising Shigella vaccine candidate. Shigella is a leading cause of severe diarrhoeal illness and death in children under five in low- and middle-income countries.
The vaccine employs GSK’s innovative GMMA technology—Generalized Modules for Membrane Antigens—which harnesses bacterial outer membrane vesicles to effectively deliver antigens. This platform is cost-efficient, scalable, often adjuvant-free, and capable of addressing multiple Shigella serotypes. The candidate targets four serotypes: S. sonnei and S. flexneri 1b, 2a, 3a.
In early clinical trials, altSonflex1‑2‑3 demonstrated a favourable safety profile and met pre-defined immunogenicity criteria. Phase 1 was conducted in Europe, followed by Phase 2 in African infants aged nine months, where interim results from 2024 confirmed strong immune responses and no safety concerns.
Under the terms of the agreement, Bharat Biotech will lead the Phase 3 trial design, regulatory filings, and large-scale manufacturing, while GSK will support clinical design, funding strategies, and commercialization planning. This collaboration builds on their previous cooperation for the RTS,S malaria vaccine transfer in 2021.
Dr Krishna Ella, Executive Chairman of Bharat Biotech, stated: “Bharat Biotech is proud to collaborate with GSK to develop a next-generation Shigella vaccine… scalable, science‑backed solutions focused on low and middle‑income countries,” highlighting the urgent need amid fragmenting healthcare access and rising antimicrobial resistance .
Thomas Breuer, GSK’s Chief Global Health Officer, added: “With young children in lower‑income countries disproportionately impacted by Shigella, the development of a low‑cost vaccine is an important goal for global public health… [Bharat Biotech’s] capacity to develop and deliver vaccines at scale” will be essential .
Shigella remains a critical public-health threat, exacerbated by increasing antimicrobial resistance. A successful vaccine like altSonflex1‑2‑3 could reduce both the incidence of severe diarrhoeal illness and inappropriate antibiotic use, helping combat AMR.
Looking ahead, the global health community will be watching for the launch and funding of Phase 3 trials, regulatory decisions across target countries, and how swiftly Bharat Biotech can scale up production to deliver this potential first approved Shigella vaccine to vulnerable populations.
