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South Africa Launches Phase 1 Trials for First Fully Made-in-Country Cholera Vaccine in 50 Years

The Phase 1 start signals a push for African vaccine self-reliance through Biovac’s partnership with the International Vaccine Institute.

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)

Overview

  • Regulator SAHPRA has approved Biovac’s oral cholera vaccine to begin human testing, with Phase 1 underway at Wits PHRU focusing on adult safety.
  • The government formally launched the clinical trials in Johannesburg, led by Health Minister Aaron Motsoaledi and Deputy Minister Nomalungelo Gina, with coordination by the South African Medical Research Council.
  • Biovac is manufacturing the vaccine end to end in South Africa after a 2022 technology transfer from the International Vaccine Institute, marking a shift beyond fill-and-finish to full production for African and global supply.
  • If initial safety results are positive, a larger Phase 3 will compare the candidate to Euvichol Plus at five South African sites, with potential approval projected for 2028 to 2029.
  • Officials cite sporadic imported cholera outbreaks and recent waterborne disease concerns as reasons to build local capacity and strengthen vaccine supply security.