Second Shigella Vaccine Candidate May Protect Children from Diarrhea

GSK plc recently announced that it has licensed its Shigella vaccine candidate, altSonflex1-2-3, to India-based Bharat Biotech International Limited (BBIL).

This agreement paves the way for the ongoing development and potential distribution of the vaccine in low- and middle-income countries where Shigella, an acute human infection of the large intestine, is the leading bacterial cause of diarrhoea, posing a significant health threat to children under five.

The urgent challenge posed by increasing antimicrobial-resistant enteric bacteria, including Shigella, highlights the broader impact a vaccine could have beyond helping to reduce illness and mortality rates.

If approved, a Shigella vaccine has the potential to indirectly reduce antibiotic consumption and help combat the rise of antimicrobial resistance.

As of June 18, 2025, there are no U.S. Food and Drug Administration (FDA)- approved Shigella vaccines.

Thomas Breuer, Chief Global Health Officer at GSK, stated in a press release, "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."

Following the technology transfer, GSK will collaborate with BBIL on its design of the Phase 3 trial and support BBIL's efforts to secure external funding. This collaboration builds on GSK's existing relationship with the Indian Biotech company, following a product transfer and license agreement in 2021 for the world's first malaria vaccine, RTS,S (Mosquirix™).

Currently, Valneva SE and LimmaTech Biologics AG are co-developing the Shigella4V2 second-generation tetravalent bioconjugate vaccine candidate against shigelllosis, which is progressing in clinical trials.