Hyderabad-based vaccine manufacturer Bharat Biotech International and global biopharma giant GSK have entered into a strategic partnership to accelerate the development of GSK’s investigational Shigella vaccine, altSonflex1-2-3. Announced on June 12, the collaboration aims to address a significant unmet public health need by progressing the vaccine candidate through its final stages of development.
Bharat Biotech to Lead Clinical and Manufacturing Efforts
Under the agreement, Bharat Biotech will spearhead the Phase 3 clinical trials, navigate regulatory approvals, and scale up large-scale manufacturing of the vaccine. Meanwhile, GSK will support the program by contributing to clinical trial design, external funding initiatives, and the access, delivery, and commercialisation strategy.
Urgent Need for a Shigella Vaccine
Shigellosis, caused by Gram-negative Shigella bacteria, is a serious inflammatory disease of the large intestine. It typically presents with watery diarrhoea, fever, abdominal pain, and bloody, mucus-filled stools. Despite its global impact—particularly among young children—no licensed vaccine currently exists to prevent the disease.
Promising Candidate Enters Final Clinical Stage
Now entering Phase 3 trials, altSonflex1-2-3 is positioned to become the first scalable, affordable, and globally accessible Shigella vaccine. According to Bharat Biotech, this in-licensed vaccine candidate addresses a critical public health gap.
Breakthrough Technology Behind the Vaccine
The vaccine is based on GSK’s Generalized Modules for Membrane Antigens (GMMA) platform, which uses bacterial outer membranes to deliver the O Antigen directly to the immune system. This technology enables high-yield, cost-effective production, making it well-suited for low-resource settings.
Strong Clinical Results Boost Confidence
As reported by The Hindu, the vaccine has already shown robust safety and immunogenicity across multiple studies. A Phase 1 trial in Europe reported a strong immune response and a favourable safety profile. Later, Phase 2 trials in Africa, including immunisation of nine-month-old infants—the primary target population—confirmed the vaccine’s safety. Interim 2024 results further validated the candidate, as it met all pre-set immunogenicity goals.
Leadership Highlights Collaborative Strengths
“This collaboration combines our strengths in innovation, manufacturing, and global health commitment,” said Krishna Ella, Executive Chairman of Bharat Biotech. “The use of GMMA technology underscores our mission to develop accessible vaccines that protect and improve lives worldwide.”
Thomas Breuer, GSK’s Chief Global Health Officer, echoed the sentiment. “This agreement allows us to combine our scientific and technological expertise with Bharat Biotech’s proven ability to develop and deliver vaccines at scale,” he said. “It’s a synergy that could save countless lives globally.”
Building on a Proven Partnership
This collaboration builds on the companies’ existing partnership, following their 2021 agreement to transfer and license the world’s first malaria vaccine, RTS,S, to Bharat Biotech. The continued alliance signals a shared vision to expand global access to life-saving vaccines.