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South Africa Begins Phase 1 Trials of First Locally Developed Oral Cholera Vaccine in 50 Years

The SAHPRA-cleared safety study at Wits’ PHRU signals a push for African vaccine self-reliance ahead of larger multi-site trials.

South African Medical Research Council head Prof Glenda Grey administers a cholera vaccine to Shadrack Makutu, a participant in the clinical trials for the vaccine developed by Biovac at the Chris Hani Baragwanath Hospital in Soweto, South Africa, Tuesday, Nov. 11, 2025. (AP Photo/ Alfonso Nqunjana)
Health Minister Dr Aaron Motsoaledi speaks at the launch of the clinical trial for the oral cholera vaccine, the first vaccine to be fully developed in SA in over 50 years, at Chris Hani Baragwanath Hospital in Johannesburg on 11 November. (Photo: Supplied / Biovac)

Overview

  • Biovac’s orally administered candidate entered Phase 1 in October at Wits’ Perinatal HIV Research Unit, focusing on safety in adults.
  • The South African Medical Research Council is coordinating the program following regulatory authorization from SAHPRA.
  • Built through a 2022 technology transfer from the International Vaccine Institute, the vaccine is being manufactured end-to-end in South Africa for the first time in more than five decades.
  • A planned Phase 3 will run at five sites in Johannesburg, Durban and East London to assess immunogenicity and compare the candidate with Euvichol Plus.
  • Officials say, if trial outcomes are positive, the vaccine could be available for use in Africa around 2028, with philanthropic backing from the Gates Foundation, Wellcome, Open Philanthropy and ELMA responding to recurring outbreaks and global supply shortages.