Early clinical trials have shown promising safety and immune response, with Phase 3 trials now underway.
Vaccine maker Bharat Biotech International entered into a partnership with GSK plc to develop and potentially use the Shigella vaccine candidate to prevent Shigellosis.
Shigellosis. is a severe form of bacterial diarrhoea that disproportionately affects children under five in low- and middle-income countries.
As part of this agreement, Hyderabad-based Bharat Biotech will lead the further development of the vaccine candidate (altSonflex1-2-3), including Phase 3 clinical trials, regulatory advancement, and large-scale manufacturing. GSK will continue to support the programme by assisting with clinical trial design, securing external funding, and contributing to the access and delivery plans and commercialisation strategy.
“With no approved vaccine currently available and antimicrobial resistance on the rise, there is an urgent need for scalable, science-backed solutions focused on low and middle-income countries. This collaboration combines our strengths in innovation, manufacturing, and global health commitment,” Krishna Ella, Executive Chairman of Bharat Biotech, said in a release on Thursday.
Thomas Breuer, Chief Global Health Officer of GSK, said: “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.”
The in-licensed Shigella vaccine candidate has already shown encouraging results in early-stage clinical trials.
“A Phase 1 study conducted in Europe demonstrated a favourable safety profile and strong immune response. Subsequent Phase 2 trials in Africa, including vaccination of 9-month-old infants reported no safety concerns. Interim results from 2024 confirmed that the candidate met its pre-set immunogenicity goals,” the Hyderabad-based company said. The vaccine is now entering Phase 3 trials under Bharat Biotech’s leadership.
Published on June 12, 2025
Comments
Comments have to be in English, and in full sentences. They cannot be abusive or personal. Please abide by our community guidelines for posting your comments.
We have migrated to a new commenting platform. If you are already a registered user of TheHindu Businessline and logged in, you may continue to engage with our articles. If you do not have an account please register and login to post comments. Users can access their older comments by logging into their accounts on Vuukle.