| アブストラクト | 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. |
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| ジャーナル名 | Drug safety |
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| 投稿日 | 2023/2/23 |
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| 投稿者 | Ogar, Comfort K; Quick, Jonathan; Gilbert, Hannah N; Vreman, Rick A; Mantel-Teeuwisse, Aukje K; Mugunga, Jean Claude |
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| 組織名 | Department of Global Health and Social Medicine, Harvard Medical School, Boston,;USA. kunacom@yahoo.com.;Utrecht Centre for Pharmaceutical Policy and Regulation, Division of;Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for;Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.;kunacom@yahoo.com.;USA.;Duke Global Health Institute, Duke University School of Medicine, Durham, USA.;Partners In Health, Boston, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36811813/ |
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