Oral Presentation: Adverse Events to COVID-19 Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Introduction: As of April 3, 2022, 31 COVID-19 vaccines had received approval for use globally (1). With the fast-tracked development and concurrent introduction of vaccines in all countries, there is a need for equitable safety surveillance to monitor adverse events following immunization (AEFIs) in high-income and low- and middle-income countries (LMICs). Objective: To profile the AEFIs to COVID-19 vaccines, explore the difference in reported AEs between Africa and the rest of the world (RoW), and understand the policy considerations that inform the decision by funding organizations to strengthen safety surveillance systems in LMICs. Methods: We used a convergent mixed methods design involving secondary analysis of 14,671,586 AEFIs to COVID-19 vaccines reported to VigiBasea by countries in the WHO Africa Region and the RoW between December 2020 and March 2022. The qualitative component consisted of 12 in-depth interviews with key policymakers from some donor/funding organizations. Results: With 87,351 out of 14,671,586 total reported AEFIs to COVID-19 vaccines (0.6%) Africa had the second-lowest crude AEFI reporting rate of 180 AEs per 1million administered doses. Reports from females made up 73.6% of reports from African and RoW compared to 24.4% for males. The highest number of reports came from persons 18-44 years. 26.0% of the reports were serious, with death being the reason for seriousness in 5% of the reports. Statistically significant differences in AEFI reporting by gender, age group, and serious AEs were found between Africa and the RoW. AstraZeneca, PfizerBioNtech, and Janssen vaccines were the most frequently associated with AEFIs in terms of the absolute number of AEs for Africa and RoW. Sputnik V contributed the highest percentage of AEs per vaccine for Africa. Headache, pyrexia, injection site pain, dizziness, and chills were the top 5 reported AEs for Africa and RoW. Qualitative findings revealed decisions of many funding organizations to fund safety surveillance in LMICs were influenced by considerations about country priorities, the perceived utility of the evidence generated for local decision making, and the contributions to global health by safety surveillance systems. Conclusion: Countries in Africa reported fewer AEFIs to COVID-19 vaccines in VigiBase relative to the RoW, with statistically significant differences in reporting of key parameters that warrant further investigation. Funding decisions by donor organizations were influenced by country priorities and the perceived value added by data generated from safety surveillance systems in LMICs to local and global decision making.