{ "abstract": "Post-market vaccine safety surveillance and research are essential to detect and evaluate rare adverse events following immunization (AEFIs) not identified in pre-licensure clinical trials, such as myocarditis post-COVID-19 vaccination. AEFI surveillance infrastructure varies between jurisdictions. Factors that enable or hinder vaccine safety evaluation across diverse settings are not well understood. The study objective was to examine clinical, social, and structural/system factors that enable AEFI case identification, reporting, data and biosample collection in high-income countries (HICs) and low-and middle-income countries (LMICs). We conducted a qualitative study informed by Interpretive Description in Kenya, South Africa, and Canada. Three participant groups were recruited using purposive and snowball sampling: (1) key informants with leadership roles in AEFI surveillance and research, (2) healthcare workers, research and laboratory staff involved in vaccine safety evaluation, and (3) past participants in COVID-19 vaccine safety studies. Data were collected through semi-structured interviews and focus group discussions. Thematic analysis was conducted. Eighteen key informants, 37 healthcare workers and research staff, and 27 past research participants were enrolled. Facilitators and barriers were identified across 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 for AEFI surveillance and research 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), and cumbersome research approval processes. Findings underscore the need for globally harmonized standards and locally tailored strategies to support AEFI surveillance and research in LMICs and HICs that are patient/participant-centered and include sustainable investments in infrastructure and workforce capacity.", "abstract_shown": true, "affiliations": [ "Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada", "South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Johannesburg, Gauteng, South Africa", "Africa Health Research Institute (AHRI), Durban, South Africa", "KEMRI - Wellcome Trust Research Programme, Kilifi, Kenya", "Wits African Leadership in Vaccinology Expertise (Wits-Alive), School of Pathology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, Gauteng, South Africa", "Canadian Center for Vaccinology, IWK Health, Dalhousie University, Halifax, Nova Scotia, Canada", "Social and Behavioural Health Sciences Division, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada", "Department of Global Health, University of Washington, Seattle, Washington, United States of America", "Global Healthcare Consulting, New Delhi, India", "Department of Pediatrics and School of Public Health, University of Alberta, Edmonton, Alberta, Canada" ], "article_type": "Research Article", "arxiv": null, "author_total": 18, "authors": [ { "affs": [ 0 ], "name": "Anila Naz AliSher" }, { "affs": [ 1 ], "name": "Shabnam Shaik", "orcid": "0000-0001-9455-4554" }, { "affs": [ 1, 2 ], "name": "Nellie Myburgh", "orcid": "0000-0001-6180-7826" }, { "affs": [ 1 ], "name": "Nomsa Ndaba" }, { "affs": [ 3 ], "name": "Alex Hinga" }, { "affs": [ 3 ], "name": "Winnie Okore" }, { "affs": [ 3 ], "name": "Samuel Sang" }, { "affs": [ 0 ], "name": "Salima Siraj", "orcid": "0009-0001-3428-1934" }, { "affs": [ 1 ], "name": "Thabisile Qwabi" }, { "affs": [ 4 ], "name": "Kimberley Gutu", "orcid": "0009-0005-3857-2762" }, { "affs": [ 3 ], "name": "Allan Matano" }, { "affs": [ 5, 6 ], "name": "Antonia Di Castri", "orcid": "0000-0002-6318-5394" }, { "affs": [ 7, 8 ], "name": "Sonali Kochhar" }, { "affs": [ 3 ], "name": "Eunice Wangeci Kagucia" }, { "affs": [ 1 ], "name": "Ziyaad Dangor" }, { "affs": [ 4 ], "name": "Clare L. Cutland" }, { "affs": [ 5, 9 ], "name": "Karina A. Top" }, { "name": "for the International Network of Special Immunization Services (INSIS) Investigators" } ], "bibtex": "https://research.draconitic.com/paper/dbshd8392fcyq.bib", "cited_by": 0, "doi": "10.1371/journal.pgph.0006142", "fulltext_url": "https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0006142", "id": "dbshd8392fcyq", "issns": [ "2767-3375" ], "landing_url": "https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0006142", "language": "en", "licence": "CC-BY-4.0", "licence_label": "CC BY 4.0", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "heading", "Adverse Events" ], [ "heading", "Africa" ], [ "heading", "Biology and Life Sciences" ], [ "heading", "Canada" ], [ "heading", "Clinical Research Design" ], [ "heading", "Covid 19" ], [ "heading", "Geographical Locations" ], [ "heading", "Geographical locations" ], [ "heading", "Immunology" ], [ "heading", "Infectious Disease Control" ], [ "heading", "Infectious Diseases" ], [ "heading", "Kenya" ], [ "heading", "Medical Conditions" ], [ "heading", "Medicine and Health Sciences" ], [ "heading", "North America" ], [ "heading", "People and Places" ], [ "heading", "People and places" ], [ "heading", "Preventive Medicine" ], [ "heading", "Public and Occupational Health" ], [ "heading", "Research Article" ], [ "heading", "Research Design" ], [ "heading", "Research and Analysis Methods" ], [ "heading", "South Africa" ], [ "heading", "Vaccination and Immunization" ], [ "heading", "Vaccine Development" ], [ "heading", "Vaccines" ], [ "heading", "Viral Diseases" ], [ "openalex", "3005|Pharmacovigilance and Adverse Drug Reactions" ], [ "plos", "/Biology and life sciences/Immunology/Vaccination and immunization" ], [ "plos", "/Biology and life sciences/Immunology/Vaccination and immunization/Vaccine development" ], [ "plos", "/Medicine and health sciences/Immunology/Vaccination and immunization" ], [ "plos", "/Medicine and health sciences/Immunology/Vaccination and immunization/Vaccine development" ], [ "plos", "/Medicine and health sciences/Medical conditions/Infectious diseases/Infectious disease control/Vaccines" ], [ "plos", "/Medicine and health sciences/Medical conditions/Infectious diseases/Viral diseases/COVID 19" ], [ "plos", "/Medicine and health sciences/Public and occupational health/Preventive medicine/Vaccination and immunization" ], [ "plos", "/Medicine and health sciences/Public and occupational health/Preventive medicine/Vaccination and immunization/Vaccine development" ], [ "plos", "/People and places/Geographical locations/Africa/Kenya" ], [ "plos", "/People and places/Geographical locations/Africa/South Africa" ], [ "plos", "/People and places/Geographical locations/North America/Canada" ], [ "plos", "/Research and analysis methods/Research design/Clinical research design/Adverse events" ] ], "openalex": "W7223995809", "pdf_url": "https://journals.plos.org/globalpublichealth/article/file?id=10.1371/journal.pgph.0006142&type=printable", "pmcid": "PMC13712616", "pmid": "42945272", "published": "2026-10-27", "publisher": "Public Library of Science", "ris": "https://research.draconitic.com/paper/dbshd8392fcyq.ris", "sources": [ { "first_seen": "2026-10-30T12:17:17Z", "native_id": "10.1371/journal.pgph.0006142", "source": "plos", "url": "https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0006142" }, { "first_seen": "2026-10-31T12:23:09Z", "native_id": "PMC13712616", "source": "pmc", "url": "https://doi.org/10.1371/journal.pgph.0006142" } ], "subjects": [ { "field": "biology", "origin": "plos:immunology", "subfield": "immunology" }, { "field": "medicine", "origin": "plos:public and occupational health", "subfield": "epidemiology-public-health" }, { "field": "medicine", "origin": "plos:infectious diseases", "subfield": "infectious-disease" } ], "title": "Strengthening post-market COVID-19 vaccine safety surveillance and research: An interpretive description study from Kenya, South Africa, and Canada", "title_text": "Strengthening post-market COVID-19 vaccine safety surveillance and research: An interpretive description study from Kenya, South Africa, and Canada", "type": "peer-reviewed", "updated_at": "2026-10-31T12:23:09Z", "url": "https://research.draconitic.com/paper/dbshd8392fcyq", "venue": "PLOS Global Public Health", "versions": [] }