GSK Licenses Shigella Vaccine Candidate to Bharat Biotech for Development

In a significant step towards combating Shigellosis, GSK plc has announced the licensing of its Shigella vaccine candidate, altSonflex1-2-3, to Bharat Biotech International Limited (BBIL). This collaboration, reported on June 12, 2025, aims to advance the development and potential distribution of the vaccine in low- and middle-income countries where Shigella poses a considerable health risk, particularly for children under five years of age.

Shigella is recognized as the leading bacterial cause of diarrheal diseases in these regions, often resulting in severe complications and fatalities. According to the World Health Organization (WHO), approximately 165 million cases of Shigellosis occur globally each year, with the most affected being vulnerable populations in developing nations (WHO, 2024). The urgency for a vaccine is amplified by the rise of antimicrobial-resistant strains of Shigella, which complicate treatment options and threaten public health.

GSK’s vaccine candidate employs innovative Generalized Modules for Membrane Antigens (GMMA) technology, a platform developed to utilize outer membrane vesicles (OMVs) from bacteria to deliver antigens that effectively stimulate the immune system. This low-cost and scalable technology is particularly well-suited for producing vaccines that can be afforded by low-income countries, as stated by Dr. Thomas Breuer, Chief Global Health Officer at GSK. He emphasized the importance of developing a vaccine that is both effective and accessible, given the lack of licensed vaccines available to combat Shigella infections.

Dr. Krishna Ella, Executive Chairman of Bharat Biotech, expressed pride in collaborating with GSK, noting the company’s extensive experience in vaccine development for infectious diseases. Bharat Biotech has previously partnered with GSK in 2021 to develop the world’s first malaria vaccine, RTS,S, and aims to leverage its expertise to ensure the Shigella vaccine reaches those most in need.

The Phase 1 clinical trial and interim analyses from Phase 2 trials have reported promising results, confirming the immunogenicity success criteria necessary for advancing to later stages of testing. The vaccine, designed to provide broad protection against prevalent Shigella serotypes, represents a critical advancement in vaccine research for enteric diseases.

Both GSK and Bharat Biotech are now focused on designing the Phase 3 trial and securing external funding. The anticipated collaboration positions them to navigate regulatory pathways and large-scale manufacturing, which are crucial for the potential impact of the vaccine on global health.

Shigellosis not only poses immediate health risks but also contributes to broader public health challenges, including the exacerbation of antimicrobial resistance (AMR). The successful development of an effective vaccine could reduce the reliance on antibiotics and help combat the rising tide of resistant infections, as highlighted in the 2024 WHO Bacterial Priority Pathogens List, which underscores the importance of vaccines in the fight against AMR.

In summary, this licensing agreement marks a pivotal moment in the fight against Shigella, aligning the strengths of GSK’s scientific innovation with Bharat Biotech’s production capabilities, with the shared goal of addressing global health challenges and improving health outcomes for vulnerable populations.

This collaboration highlights a broader trend in the pharmaceutical industry focused on developing affordable vaccines for neglected tropical diseases, aiming to bridge the gap in healthcare access for low-income regions. As GSK and Bharat Biotech move forward, the potential for this vaccine to save lives and reduce disease burden remains a critical priority for both organizations and the global health community at large.