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Peer-reviewedCC BY 4.0PLOS Global Public Health

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

  • Anila Naz AliSher1
  • Shabnam Shaik2
  • Nellie Myburgh2,3
  • Nomsa Ndaba2
  • Alex Hinga4
  • Winnie Okore4
  • Samuel Sang4
  • Salima Siraj1
  • Thabisile Qwabi2
  • Kimberley Gutu5
  • Allan Matano4
  • Antonia Di Castri6,7
6 more authors
  • Sonali Kochhar8,9
  • Eunice Wangeci Kagucia4
  • Ziyaad Dangor2
  • Clare L. Cutland5
  • Karina A. Top6,10
  • for the International Network of Special Immunization Services (INSIS) Investigators
10 affiliations
  1. 1Faculty of Nursing, University of Alberta, Edmonton, Alberta, Canada
  2. 2South African Medical Research Council, Vaccines and Infectious Diseases Analytics Research Unit, University of the Witwatersrand, Johannesburg, Gauteng, South Africa
  3. 3Africa Health Research Institute (AHRI), Durban, South Africa
  4. 4KEMRI - Wellcome Trust Research Programme, Kilifi, Kenya
  5. 5Wits African Leadership in Vaccinology Expertise (Wits-Alive), School of Pathology, Faculty of Health Science, University of the Witwatersrand, Johannesburg, Gauteng, South Africa
  6. 6Canadian Center for Vaccinology, IWK Health, Dalhousie University, Halifax, Nova Scotia, Canada
  7. 7Social and Behavioural Health Sciences Division, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada
  8. 8Department of Global Health, University of Washington, Seattle, Washington, United States of America
  9. 9Global Healthcare Consulting, New Delhi, India
  10. 10Department of Pediatrics and School of Public Health, University of Alberta, Edmonton, Alberta, Canada
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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.

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Cite

BibTeXRIS
BibTeX
@article{alisher2026strengthening,
  title = {{Strengthening post-market COVID-19 vaccine safety surveillance and research: An interpretive description study from Kenya, South Africa, and Canada}},
  author = {Anila Naz AliSher and Shabnam Shaik and Nellie Myburgh and Nomsa Ndaba and Alex Hinga and Winnie Okore and Samuel Sang and Salima Siraj and Thabisile Qwabi and Kimberley Gutu and Allan Matano and Antonia Di Castri and Sonali Kochhar and Eunice Wangeci Kagucia and Ziyaad Dangor and Clare L. Cutland and Karina A. Top and for the International Network of Special Immunization Services (INSIS) Investigators},
  journal = {PLOS Global Public Health},
  year = {2026},
  month = oct,
  doi = {10.1371/journal.pgph.0006142},
  url = {https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0006142},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Strengthening post-market COVID-19 vaccine safety surveillance and research: An interpretive description study from Kenya, South Africa, and Canada
AU  - Anila Naz AliSher
AU  - Shabnam Shaik
AU  - Nellie Myburgh
AU  - Nomsa Ndaba
AU  - Alex Hinga
AU  - Winnie Okore
AU  - Samuel Sang
AU  - Salima Siraj
AU  - Thabisile Qwabi
AU  - Kimberley Gutu
AU  - Allan Matano
AU  - Antonia Di Castri
AU  - Sonali Kochhar
AU  - Eunice Wangeci Kagucia
AU  - Ziyaad Dangor
AU  - Clare L. Cutland
AU  - Karina A. Top
AU  - for the International Network of Special Immunization Services (INSIS) Investigators
PY  - 2026
DA  - 2026/10/27
JO  - PLOS Global Public Health
DO  - 10.1371/journal.pgph.0006142
UR  - https://journals.plos.org/globalpublichealth/article?id=10.1371/journal.pgph.0006142
AB  - 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.
SN  - 2767-3375
ER  -