Abstract
Introduction/Objective: Rapid global approval of coronavirus disease 2019 (COVID-19) vaccines and concurrent introduction in high-income countries and low- and middle-income countries (LMIC) highlights the importance of equitable safety surveillance of adverse events following immunization (AEFIs). We profiled AEFIs to COVID-19 vaccines, explored reporting differences between Africa and the rest of the world (RoW), and analyzed policy considerations that inform strengthening of safety surveillance in LMICs. Methods: Using a convergent mixed-methods design we compared the rate and profile of COVID-19 vaccines’ AEFIs reported to VigiBase by Africa versus the RoW, and interviewed policymakers to elicit considerations that inform the funding of safety surveillance in LMICs. Results: With 87,351 out of 14,671,586 AEFIs, Africa had the second-lowest crude number and a reporting rate of 180 adverse events (AEs) per million administered doses. Serious AEs (SAEs) were 27.0%. Death accounted for about 10.0% of SAEs. Significant differences were found in reporting by gender, age group, and SAEs between Africa and the RoW. AstraZeneca and Pfizer BioNTech vaccines were associated with a high absolute number of AEFIs for Africa and RoW; Sputnik V contributed a considerably high rate of AEs per 1 million administered doses. Funding decisions for safety surveillance in LMICs were not based on explicit policies but on country priorities, perceived utility of data, and practical implementation issues. Conclusion: African countries reported fewer AEFIs relative to the RoW. To enhance Africa’s contribution to the global knowledge on COVID-19 vaccine safety, governments must explicitly consider safety monitoring as a priority, and funding organizations need to systematically and continuously support these programs.
| Original language | English |
|---|---|
| Pages (from-to) | 357-370 |
| Number of pages | 14 |
| Journal | Drug Safety |
| Volume | 46 |
| Issue number | 4 |
| DOIs | |
| Publication status | Published - Apr 2023 |
Bibliographical note
Publisher Copyright:© 2023, The Author(s).
Funding
Comfort K. Ogar received funds from Harvard University and the Ronda Stryker and William Johnston MMSc Fellowship in Global Health Delivery to undertake the research work as part of her master’s thesis work. However, no funding support was received for the writing of the manuscript. The Global Health and Social Medicine (GHSM) department of Harvard Medical School (HMS) paid the fee for open access publication of this article. We wish to acknowledge the contribution of Patrick C. Souverein of Utrecht University, who helped with extracting the VigiBase data that was used for the quantitative study. We acknowledge all the key policymakers from the different organizations that provided their rich perspectives during the interview that informed the qualitative component of this work. We use this opportunity to honor a pharmacovigilance hero, Sten Olsson, who was instrumental in the establishment of a pharmacovigilance system in many countries in Africa. He was a member of the team that developed the protocol for this work. VigiBase, the WHO global database of reported potential side effects of medicinal products, developed and maintained by Uppsala Monitoring Centre (UMC), is the source of the information used for the quantitative component of this study. The information comes from a variety of sources, and the probability that the suspected adverse effect is drug related is therefore not the same in all cases. The information provided in this study does not represent the opinion of the UMC or the WHO.
| Funders |
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| World Health Organization |
| Harvard University |
| Uppsala Monitoring Centre |
