Lessons learnt during establishment of COVID-19 active vaccine safety surveillance in nine African countries.

Background: Globally, several gaps in vaccine safety surveillance exist, particularly in low- and middle- income countries (LMICs). Establishing and maintaining vaccine surveillance platforms in resource-constrained settings poses significant challenges. These countries often rely on paper-based medical records and immunization cards, lack unique patient identifiers across the healthcare systems, have limited electronic data capture capabilities, and face a shortage of clinical reviewers for case assessments. This report highlights the establishment of two active vaccine safety surveillance studies across nine African countries: (i) Active COVID-19 vaccine safety surveillance (ACVaSS) in eight COVAX 92 Advanced Market Commitment (AMC-92) eligible African countries including Ethiopia, Ghana, Kenya, Mali, Malawi, Mozambique, Nigeria and Eswatini and (ii) the South African COVID-19 vaccine safety surveillance study (SA-CVSS).

Methods: Both ACVaSS and SA-CVSS were hospital-based sentinel active surveillance studies designed to monitor the safety of COVID-19 vaccines in the aforementioned COVAX AMC-92 countries and South Africa, a middle-income African country. Patients presenting to healthcare facilities with illnesses resembling pre-selected adverse events of special interest (AESIs), were enrolled, with informed consent, into the studies. The Brighton Collaboration Case Definitions were applied to classify AESIs.

Findings: Over 60,000 admitted patients were screened and over 12,700 eligible patients were enrolled in 18 months. Despite challenges in accessing and abstracting data from predominantly paper-based medical and vaccination records, the identification of specific AESIs and estimating association with vaccination status was feasible in LMIC healthcare facilities.

Conclusions: The establishment of active vaccine safety surveillance sentinel sites is achievable in LMICs, though the lack of digital medical records hindered data accessibility and availability. Regulatory authorities, health departments and organizations supporting immunization programs must prioritize the development, maintenance and funding of active vaccine safety surveillance systems. Such surveillance is crucial to ensuring that new vaccines are properly monitored and assessed for safety following their introduction and use in these populations.

Funding: The SA-CVSS study was funded by a US CDC Grant to the GVDN (grant reference: CDC Funder Award Number: 1 NU38CK000485-01-00), the South African Medical Research Council (SAMRC) and the Task Force for Global Health (RVD_CDC-COV). Gavi, The Vaccine Alliance, funded the ACVaSS study (Agreement reference: MEL10500921).