Lecturer and Pharmacovigilance Consultant Department of Pharmacy Practice, University of Health and Allied Sciences Kumasi, Ghana
Background: Despite the rigor of pre-marketing vaccine trials, the safety of new vaccines is not completely understood from pre-authorization clinical trial data as these trials are conducted in controlled settings different from settings of real-world use. It is therefore imperative to report adverse events following immunization (AEFI) after regulatory approval of vaccines for a better understanding of their safety profiles.
Objectives: This study assessed adverse events following immunizations (AEFIs) associated with COVID-19 vaccines in the open access database, VigiAccess and determined AEFI reporting trend across all continents of the world.
Methods: The was cross-sectional in design. VigiAccess was searched on 10 November 2021 for all reported adverse events following the introduction of COVID-19 vaccines. After entering the search term, “COVID-19 vaccines” in VigiAccess, information on the following brands of COVID-19 vaccines were retrieved from the database: Valneva, MVC-COV1901 (Medigen), Moderna, AstraZeneca UK, Janssen, Pfizer BioNTech, Korea AstraZeneca, MC Pharma, and recombinant adenovirus type 5 vector by Convidecia. Data were captured among age groups, sex, and continents of the world and entered into Statistical Package for Social Sciences (SPSS) version 25. Descriptive data were summarized using tables. Frequencies and percentages were used to categorize descriptive variables.
Results: The top 10 commonly reported AEFI types were as follows: general disorders and vaccine administrative site conditions (1,481,549, 60.1%), nervous system disorders (1,046,928, 42.6%), musculoskeletal and connective tissue disorders (704,657, 28.6%), gastrointestinal disorders (495,997, 20.2%), investigations with undesirable outcomes (341,677, 13.9%), skin and subcutaneous tissue disorders (335,932, 13.6%), respiratory, thoracic and mediastinal disorders (262,158, 10.6%), infections and infestations (180,873, 7.3%), vascular disorders (132,533, 5.3%), and injury, poisoning and procedural complications (122,519, 5%). Moreover, the 10 most commonly reported AEFI manifestations were headache, pyrexia, fatigue, chills, myalgia, nausea, arthralgia, malaise, injection site pain, and pain in extremity. There were no causal associations between the AEFIs and the COVID-19 vaccines studied. Among the continents of the world, AEFI reports were highest for Europe (50%) and lowest for Africa (3%).
Conclusions: There needs to be an improvement in COVID-19-related AEFI reporting particularly in African countries. The general public must be educated on the fact that COVID-19-related AEFIs reported in VigiAccess do not have causal relationships with the vaccines and must therefore not be alarmed.
