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

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...

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Main Authors: Charles S. Wiysonge, Duduzile Ndwandwe, Lindi Mathebula, Ameena Goga, Glenda Gray
Format: Article
Language:English
Published: Academy of Science of South Africa 2022-05-01
Series:South African Journal of Science
Subjects:
Online Access:https://sajs.co.za/article/view/13224
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author Charles S. Wiysonge
Duduzile Ndwandwe
Lindi Mathebula
Ameena Goga
Glenda Gray
author_facet Charles S. Wiysonge
Duduzile Ndwandwe
Lindi Mathebula
Ameena Goga
Glenda Gray
author_sort Charles S. Wiysonge
collection DOAJ
description 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.
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spelling doaj.art-e294c99d1b4c41e2ae5619ae7ad5258c2022-12-22T00:23:30ZengAcademy of Science of South AfricaSouth African Journal of Science1996-74892022-05-011185/610.17159/sajs.2022/13224Randomised trials of COVID-19 vaccines in Africa – charting the path forwardCharles S. Wiysonge0Duduzile Ndwandwe1Lindi Mathebula2Ameena Goga3Glenda Gray41.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 AfricaCochrane South Africa, South African Medical Research Council, Cape Town, South AfricaCochrane South Africa, South African Medical Research Council, Cape Town, South Africa1.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 AfricaOffice of the President and CEO, South African Medical Research Council, Cape Town, South Africa 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. https://sajs.co.za/article/view/13224COVID-19 vaccinesAfricapandemicclinical trialsprospective registration
spellingShingle Charles S. Wiysonge
Duduzile Ndwandwe
Lindi Mathebula
Ameena Goga
Glenda Gray
Randomised trials of COVID-19 vaccines in Africa – charting the path forward
South African Journal of Science
COVID-19 vaccines
Africa
pandemic
clinical trials
prospective registration
title Randomised trials of COVID-19 vaccines in Africa – charting the path forward
title_full Randomised trials of COVID-19 vaccines in Africa – charting the path forward
title_fullStr Randomised trials of COVID-19 vaccines in Africa – charting the path forward
title_full_unstemmed Randomised trials of COVID-19 vaccines in Africa – charting the path forward
title_short Randomised trials of COVID-19 vaccines in Africa – charting the path forward
title_sort randomised trials of covid 19 vaccines in africa charting the path forward
topic COVID-19 vaccines
Africa
pandemic
clinical trials
prospective registration
url https://sajs.co.za/article/view/13224
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