GSK announced that it is licensing altSonflex1-2-3, its Shigella vaccine candidate, to Bharat Biotech for further development and potential distribution in low- and middle-income countries. According to the company, results from a Phase I trial and interim Phase II data show the candidate met key immunogenicity benchmarks. The vaccine utilizes Generalized Modules for Membrane Antigens (GMMA) technology, which uses outer membrane vesicles from bacteria to elicit strong immune responses, often without adjuvants.¹

How will GSK and Bharat Biotech's Partnership Expand Access to the altSonflex1-2-3 Shigella Vaccine?

“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,” said Thomas Breuer, chief global health officer, GSK, in a press release. “With no licensed vaccines widely available, the development of our Shigella vaccine candidate which has demonstrated promising clinical trial results, fills us with immense pride. We are proud to collaborate with Bharat Biotech, whose expertise in developing and supplying vaccines for infectious diseases, especially as a trusted supplier to Gavi, the Vaccine Alliance, and UNICEF, positions them to further advance this important work. This agreement allows us to combine our strengths in science, research, and technology with Bharat Biotech's capacity to develop and deliver vaccines at scale, potentially preventing illness and saving lives around the world."

GSK and Bharat Biotech Deepen Global Health Collaboration

As part of the agreement, GSK will support Phase III trial design and help Bharat Biotech pursue external funding. The move builds on a previous 2021 partnership between the companies for the world’s first malaria vaccine, RTS,S.¹

“As the market leader in vaccines for diarrhoeal infections—including rotavirus, typhoid, polio, non-typhoidal salmonella, cholera, and paratyphi—Bharat Biotech is proud to collaborate partner with GSK with the ambition to develop a Shigella vaccine candidate,” said Krishna Ella, executive chairman, Bharat Biotech, in the press release. “Shigellosis continues to be a serious public health concern, particularly among children under the age of five in low- and middle-income countries, where access to timely and effective medical intervention can be limited. The absence of a licensed vaccine, combined with the growing threat of antimicrobial resistance, underscores the urgency of developing effective, and affordable preventive solutions.”

Addressing Shigella’s Global Burden and Antimicrobial Resistance

According to the Centers for Disease Control and Prevention (CDC), approximately 450,000 cases of shigellosis occur in the United States annually, 242,000 of which are antimicrobial-resistant.2 Children younger than five years of age have the highest risk of getting it; however, people can get it at any age. Additionally, gay, bisexual, and other men who have sex with men are at increased risk for infection. The CDC estimates direct medical costs associated with shigellosis total approximately $93 million annually.³

“Bharat Biotech is committed to leveraging its expertise in vaccine development and manufacturing to ensure that, if successful, this innovative vaccine reaches those who need it most,” continued Ella, in the press release. “This licensing agreement reflects our shared commitment to global health equity and positions us to advance altSonflex1-2-3 through late-stage development, and if successful, through regulatory pathways, and large-scale manufacturing. The use of GMMA technology represents a potential breakthrough in vaccine design that aligns with our mission to make science-driven, accessible vaccines. Together with GSK, we aim to contribute to the fight against Shigella, prevent suffering, and help combat the rise of antimicrobial resistance, which continues to threaten millions of lives worldwide.”

References

1. GSK licenses Shigella vaccine candidate to Bharat Biotech for continued development. GSK. June 12, 2025. Accessed June 12, 2025. https://www.gsk.com/en-gb/media/press-releases/gsk-licenses-shigella-vaccine-candidate-to-bharat-biotech-for-continued-development/

2. Clinical Overview of Shigellosis. CDC. Accessed June 12, 2025. https://www.cdc.gov/shigella/hcp/clinical-overview/index.html

3. About Shigella Infection. CDC. Accessed June 12, 2025. https://www.cdc.gov/shigella/about/index.html#:~:text=Shigella%20cause%20an%20estimated%20450%2C000,Shigella%20flexneri