Page 183 - SAMRC AnnualReport 2025-26

P E R FOR M A NC E I N FOR M A T I ON

community engagement and support continue.
The trial’s conduct is supported by the SAMRC and
the IVI in Korea.
Once Biovac obtains WHO prequalification for the
oral cholera vaccine, this will increase manufacturing
capacity and add to global stockpiles. Biovac
will then be the sole manufacturer in Africa. This

Sunday Times Article on the launch of
BRILLIANT-011.

SAMRC-IVI-BIOVAC Collaboration
Cholera cases have been increasing globally since
2021, with high case fatality rates. The large number Attendees at the Biovac OCV trial
of outbreaks has led to unprecedented demand for investigators' meeting held in Cape Town in
August 2025.
vaccines. While global oral cholera vaccine supply
has increased 18-fold between 2013 and 2023,
the large and sustained increase in demand has
strained the global stockpile of cholera vaccines. A
major global challenge in cholera control remains a
limited vaccine supply relative to demand.
The SAMRC, together with the International Vaccine
Institute (IVI), Korea, and the Biovac Institute, South
Africa, are collaborating on a Phase I/III, multicentre,
observer-blinded, randomised, active-controlled
trial to evaluate the immune non-inferiority,
safety, and lot-to-lot consistency of the BIOVAC- Prof Glenda Gray, Dr Michelle Mulder,
manufactured oral cholera vaccine (OCV) in healthy Dr Morena Makhoana, together with
participants aged 1 to 45 years. This clinical trial representatives from the Department of
Science, Technology and Innovation, the
aims to establish the immunogenicity and safety National Department of Health, and the
profile of the Biovac OCV compared to the available Gauteng Department of Health, at the launch
WHO pre-qualified vaccine Euvichol®-Plus. The of the trial in Johannesburg in November 2025.
SAMRC has secured and is managing a grant of R78
million from the ELMA Vaccines and Immunisation
Foundation for this clinical trial.

During the financial year, this programme
successfully secured SAPHRA approval for BIOVAC
to manufacture the clinical trial material in May
2025, obtained SAHPRA approval for the clinical
trial in September 2025, and received ethics
approvals for all five clinical trial sites. The trial also
gained approval and endorsement from the South
African Department of Health. It commenced The launch of the clinical trial for South Africa’s
in October 2025 and was widely publicised and first locally developed Oral Cholera Vaccine
celebrated worldwide. All predefined targets for (OCV-S), held at Chris Hani Baragwanath
the clinical trial are being achieved. Data quality is Academic Hospital.
actively monitored and remains satisfactory, while

SA M R C A N N U A L R EP O R T 2 0 2 5 / 2 0 2 6 181