Serious Adverse Events Following Immunization (SAE) with the Covid 19 Vaccine in Morocco: Pharmacovigilance Centre Database: An International Journal of Medical Toxicology and Drug Experience

ABSTRACT

Background/Introduction: Since the beginning of the national vaccination strategy development, The Moroccan pharmacovigilance centre was involved in the national vaccination campaign to ensure a successful covid 19 AEFIs surveillance. Objective/Aim: This study is a descriptive analysis of (SAE) with covid 19 vaccines in Morocco during the vaccination campaign 2021 Methods: Data on adverse events following immunisation (AEFI) was collected since January 28, 2021 through the national passive and stimulated surveillance systems. The AEFIs including serious adverse events (SAEs) were classified using the MedDRA terminology. SAE were analyzed according to system organ class, seriousness criterias, patient characteristics, outcome, reporter designation and Covid 19 vaccine brand. Results: In more than 8 Millions vaccines, 15 187 AEFI were reported (1.92 per 1000 immunizations), 181 cases reported at least one SAE (1.2% of total cases), which represents 0.03 cases per 1000 vaccines. The sex ratio is 1.02. 154 cases were reported with the Astra Zeneca (AZ) vaccine, which represents 1.4% out 10 930 cases AZ reported , and 25 cases with the Sinopharm vaccine, which represents 0.6% of the 3859 cases reported with this vaccine. The seriousness criteria was hospitalization in 62.5% of cases. The cases classified as severe reported an average of 3 AEFIs per case classified in the different MedDRA SOCs, represented mainly by neurological conditions (44.1%) and general disorders (28.9%). This study showed that the AEFI reporting rate after covid 19 vaccination was high. Mild systemic reactions accounted for the majority of reported AEFI, and fatal SAEs were rare Conclusion: This study showed the importance of an efficient safety monitoring system which can detect and characterize SAE and set up the safety profile of this new covid 19 vaccines.