tetano
Editor, Senior Moderator
Drug Saf
. 2023 Feb 22.
doi: 10.1007/s40264-023-01279-3. Online ahead of print.
Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study
Comfort K Ogar[SUP] 1 2 [/SUP], Jonathan Quick[SUP] 3 4 [/SUP], Hannah N Gilbert[SUP] 3 [/SUP], Rick A Vreman[SUP] 5 [/SUP], Aukje K Mantel-Teeuwisse[SUP] 5 [/SUP], Jean Claude Mugunga[SUP] 3 6 [/SUP]
Affiliations
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.
. 2023 Feb 22.
doi: 10.1007/s40264-023-01279-3. Online ahead of print.
Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study
Comfort K Ogar[SUP] 1 2 [/SUP], Jonathan Quick[SUP] 3 4 [/SUP], Hannah N Gilbert[SUP] 3 [/SUP], Rick A Vreman[SUP] 5 [/SUP], Aukje K Mantel-Teeuwisse[SUP] 5 [/SUP], Jean Claude Mugunga[SUP] 3 6 [/SUP]
Affiliations
- PMID: 36811813
- DOI: 10.1007/s40264-023-01279-3
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.