Empowering African Expertise: Enhancing Safety Data Integration and Signal Detection for COVID-19 Vaccines Through the African Union Smart Safety Surveillance Joint Signal Management Group

Victoria Prudence Nambasa (), Hannah May Gunter, Modupe Bamidele Adeyemo, Neetesh Yanish Bhawaneedin, Marc Blockman, George Tsey Sabblah, John Owusu Gyapong, Eric Muriithi Guantai, Tamrat Abebe, Workeabeba Abebe, Henry Jeremy Lawson, Mercedes Chawada Leburu, Abdullahi Mohammed, Kwame Amponsa-Achiano, Mafora Florah Matlala, Uchenna Geraldine Elemuwa, Hudu Mogtari, Alexander Kwadwo Nyarko, Marione Schönfeldt, Mercy Kamupira, Kerrigan McCarthy, Yohannes Lakew Tefera, Asnakech Alemu, Kabir Mawashi Yusuf, Obi Emelife, Ladji Sidibe, Kudakwashe Dandajena, Kenneth Onu, Mojisola Christianah Adeyeye, Delese Mimi Darko, Heran Gerba, Boitumelo Semete, Fred Siyoi, Aggrey Ambali and Johanna Catharina Meyer ()
Additional contact information
Victoria Prudence Nambasa: African Union Development Agency-NEPAD
Hannah May Gunter: University of Cape Town
Modupe Bamidele Adeyemo: African Union Development Agency-NEPAD
Neetesh Yanish Bhawaneedin: Patient Safety Monitoring, Safety and Surveillance Group, Medicines and Healthcare products Regulatory Agency
Marc Blockman: University of Cape Town
George Tsey Sabblah: Food and Drugs Authority (FDA)
John Owusu Gyapong: University of Health and Allied Sciences
Eric Muriithi Guantai: University of Nairobi
Tamrat Abebe: Addis Ababa University
Workeabeba Abebe: Addis Ababa University
Henry Jeremy Lawson: University of Ghana Medical School
Mercedes Chawada Leburu: African Union Development Agency-NEPAD
Abdullahi Mohammed: Ahmadu Bello University Teaching Hospital SHIKA
Kwame Amponsa-Achiano: Ghana Health Service
Mafora Florah Matlala: South African Health Products Regulatory Authority (SAHPRA)
Uchenna Geraldine Elemuwa: National Agency for Food and Drug Administration and Control (NAFDAC)
Hudu Mogtari: African Union Development Agency-NEPAD
Alexander Kwadwo Nyarko: University of Ghana School of Pharmacy, University of Ghana
Marione Schönfeldt: Directorate: Child, Youth and School Health
Mercy Kamupira: Population Council
Kerrigan McCarthy: National Institute for Communicable Diseases
Yohannes Lakew Tefera: Ministry of Health
Asnakech Alemu: Ethiopian Food and Drug Authority
Kabir Mawashi Yusuf: National Primary Health Care Development Agency
Obi Emelife: National Primary Health Care Development Agency
Ladji Sidibe: African Union Development Agency-NEPAD
Kudakwashe Dandajena: African Union Development Agency-NEPAD
Kenneth Onu: African Union Development Agency-NEPAD
Mojisola Christianah Adeyeye: National Agency for Food and Drug Administration and Control (NAFDAC)
Delese Mimi Darko: Food and Drugs Authority (FDA)
Heran Gerba: Ethiopian Food and Drug Authority
Boitumelo Semete: South African Health Products Regulatory Authority (SAHPRA)
Fred Siyoi: Pharmacy and Poisons Board
Aggrey Ambali: African Union Development Agency-NEPAD
Johanna Catharina Meyer: Sefako Makgatho Health Sciences University

Drug Safety, 2025, vol. 48, issue 3, No 4, 233-249

Abstract: Abstract Introduction The COVID-19 pandemic accelerated new vaccine development. Limited safety data necessitated robust global safety surveillance to accurately identify and promptly communicate potential safety issues. The African Union Smart Safety Surveillance (AU-3S) program established the Joint Signal Management (JSM) group to support identification of potential vaccine safety concerns in five pilot countries (Ethiopia, Ghana, Kenya, Nigeria, South Africa), accounting for approximately 35% of the African population. Objective Our objective was to provide an overview of the JSM group’s role in supporting signal management activities for the AU-3S program during the COVID-19 pandemic. Methods Spontaneous, electronically reported COVID-19 vaccine adverse events following immunization (AEFI) from each country's safety data were integrated into the interim Data Integration and Signal Detection system. Statistical disproportionality methods were used to identify and review vaccine–event combinations (VECs) for potential safety concerns. The JSM group—which comprised pharmacovigilance and subject matter experts from National Medicine Regulatory Authorities, Expanded Programs on Immunization, and vaccine safety committees—conducted signal detection activities on cross-country safety data and provided recommendations. Results From April 2021 to December 2023, a total of 48,294 spontaneously reported AEFI were analyzed for six COVID-19 vaccines (NRVV Ad [ChAdOx1 nCoV-19]; Ad26.COV2.S; Elasomeran; Tozinameran; Covid-19 vaccine [Vero Cell], Inactivated; NRVV Ad26 [Gam-Covid-Vac]) administered in Ethiopia (34.6%), Nigeria (30.3%), South Africa (16.9%), Ghana (13.5%), and Kenya (4.7%). Overall, 2,742 VECs were validated. A causal association between the COVID-19 vaccines and the reported AEFI cannot be inferred, as data were reported spontaneously. JSM group recommendations included monitoring for further evidence, no immediate action required, engaging marketing authorization holder(s) for additional information, or sensitizing healthcare providers and/or the public about events. Although no new safety signals were identified, nine safety-related recommendations were issued, including patient and healthcare provider education. Conclusions The JSM group established a scalable and replicable model for future signal management of other priority health products in low- and middle-income countries, fostering ongoing collaboration and capacity building. Knowledge and experience gained from this pilot initiative will guide stakeholders in future safety surveillance initiatives within the African continent.

Date: 2025
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DOI: 10.1007/s40264-024-01493-7

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