Study maps barriers to COVID-19 vaccine safety surveillance in Kenya, South Africa, and Canada

Post-market vaccine safety surveillance is essential for detecting rare adverse events following immunization (AEFIs) that pre-licensure clinical trials cannot capture, such as myocarditis after COVID-19 vaccination. A qualitative study conducted in Kenya, South Africa, and Canada has now examined which clinical, social, and structural factors help or hinder the identification, reporting, and investigation of AEFIs, as well as data and biosample collection, across high-income countries (HICs) and low- and middle-income countries (LMICs).

The research, informed by the Interpretive Description methodology, recruited three participant groups through purposive and snowball sampling: key informants with leadership roles in AEFI surveillance and research, healthcare workers and research or laboratory staff involved in vaccine safety evaluation, and past participants in COVID-19 vaccine safety studies. In total, 18 key informants, 37 healthcare workers and research staff, and 27 past research participants were enrolled. Data were collected through semi-structured interviews and focus group discussions and analyzed thematically.

Findings fell into two domains: AEFI surveillance and investigation, and vaccine safety research participation. AEFI surveillance and investigation were shaped by trust in system responsiveness, beliefs and awareness around AEFI reporting, digital innovation, and implementation gaps. Research participation was shaped by altruism and social influence, logistics and research infrastructure, and institutional policies and privacy.

Facilitators included established policies and procedures for surveillance, digital tools, empathic communication about AEFIs, and convenient research processes. Barriers included limitations in workforce capacity, diagnostic testing, and funding—especially in LMICs—alongside cumbersome research approval processes. The authors conclude that globally harmonized standards combined with locally tailored strategies are needed to support AEFI surveillance and research in both LMICs and HICs, with approaches that are patient- and participant-centered and backed by sustainable investment in infrastructure and workforce capacity.

Subject of Research: Factors enabling and hindering post-market COVID-19 vaccine adverse event surveillance and research in Kenya, South Africa, and Canada

Article Title: Strengthening post-market COVID-19 vaccine safety surveillance and research: An interpretive description study from Kenya, South Africa, and Canada

Article References: Naz AliSher, A., Shaik, S., Myburgh, N., Ndaba, N., Hinga, A., Okore, W., Sang, S., Siraj, S., Qwabi, T., Gutu, K., Matano, A., Di Castri, A., Kochhar, S., Kagucia, E. W., Dangor, Z., Cutland, C. L., Top, K. A., & for the International Network of Special Immunization Services (INSIS) Investigators (2026). Strengthening post-market COVID-19 vaccine safety surveillance and research: An interpretive description study from Kenya, South Africa, and Canada. PLOS Global Public Health, 6(10), e0006142. https://doi.org/10.1371/journal.pgph.0006142

Image Credits: AI Generated

DOI: 10.1371/journal.pgph.0006142

Keywords: vaccine safety, AEFI surveillance, COVID-19 vaccines, pharmacovigilance, Kenya, South Africa, Canada, qualitative research, LMICs, health systems, Strengthening, post-market