Randomised trials of COVID-19 vaccines in Africa – charting the path forward

Charles S. Wiysonge; Duduzile  Ndwandwe; Lindi Mathebula; Ameena Goga; Glenda Gray

doi:10.17159/sajs.2022/13224

Authors

Charles S. Wiysonge 1.Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa; 2.HIV and Other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa https://orcid.org/0000-0002-1273-4779
Duduzile Ndwandwe Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa https://orcid.org/0000-0001-7129-3865
Lindi Mathebula Cochrane South Africa, South African Medical Research Council, Cape Town, South Africa https://orcid.org/0000-0002-4213-7318
Ameena Goga 1.HIV and other Infectious Diseases Research Unit, South African Medical Research Council, Durban, South Africa; 2.Department of Paediatrics and Child Health, University of Pretoria, Pretoria, South Africa https://orcid.org/0000-0002-2394-6486
Glenda Gray Office of the President and CEO, South African Medical Research Council, Cape Town, South Africa https://orcid.org/0000-0003-4649-1477

DOI:

https://doi.org/10.17159/sajs.2022/13224

Keywords:

COVID-19 vaccines, Africa, pandemic, clinical trials, prospective registration

Abstract

Vaccines have played a critical role in controlling disease outbreaks, hence the proliferation of the development and testing of multiple vaccine candidates during the COVID-19 pandemic. Randomised trials are gold standards for evaluating the safety and efficacy of pharmaceutical interventions such as COVID-19 vaccines. However, contextual differences may attenuate effects of COVID-19 vaccines. Thus, the need to conduct COVID-19 vaccine trials in all settings, including in Africa. We conducted a cross-sectional analysis of planned, ongoing, and completed COVID-19 vaccine trials in Africa. We searched the South African National Clinical Trials Register, Pan African Clinical Trials Registry, and International Clinical Trials Registry Platform (ICTRP) on 12 January and 30 April 2022; and complemented this with a search of ClinicalTrials.gov on 17 May 2022. We screened the search output and included randomised trials with at least one recruitment site in Africa. We identified only 108 eligible trials: 90 (83%) evaluating candidate COVID-19 vaccines, 11 (10%) assessing if existing vaccines could prevent SARS-CoV-2 infection, and 7 (7%) evaluating interventions for improving COVID-19 vaccination coverage. South Africa had the highest number of trials at 58 (54%). Beyond South Africa, countries with more than 10 trial sites include Kenya, Ghana, Egypt, Uganda, and Zimbabwe. Among the trials, 14 (13%) do not have principal investigators based in Africa, 39 (30%) are funded by industry, and 91 (84%) are funded by institutions based outside the host country. COVID-19 vaccine trials with recruitment sites in Africa represented only 7% of the 1453 COVID-19 vaccine trials in the ICTRP. The paucity of COVID-19 vaccine trials conducted on the African continent is a cause for concern. This has implications for the role that Africa may play in future pandemics.

Significance:

There are generally very few vaccine trials conducted in Africa, relative to the rest of the world.
The limited vaccine trials in Africa could be attributed to limited expertise and resources, both human and material, as well as lack of perceived market.
It is reassuring that many COVID-19 vaccines are planned, being conducted, or have been conducted in multiple African countries; but there is a need for more African public sector funding for vaccine trials on the continent.