Post-Pandemic Real-World Safety Profile and Neurological Adverse Events Associated with the Sinopharm Vaccine: A Global Perspective
Background: The widespread administration of coronavirus disease 2019 (COVID-19) vaccines has substantially reduced morbidity and mortality worldwide. Among the vaccines deployed globally, the Sinopharm BBIBP-CorV vaccine has been extensively utilized across Asia, Africa, the Middle East, and several developing countries. Although its overall safety profile has been reported as favorable, concerns regarding rare neurological adverse events continue to warrant systematic evaluation in post-pandemic settings.
Objective: To investigate the real-world safety profile of the Sinopharm vaccine with particular emphasis on neurological adverse events reported following immunization and to identify factors associated with serious neurological outcomes.
Methods: A multicenter pharmacovigilance-based observational study is proposed utilizing post-marketing surveillance reports collected from international adverse event databases between January 2021 and December 2025. Neurological events reported following Sinopharm vaccination will be identified, classified, and analyzed according to demographic characteristics, vaccination dose, onset interval, severity, and clinical outcomes. Disproportionality analyses and multivariable regression models will be employed to evaluate associations between patient characteristics and serious neurological adverse events.
Results: It is anticipated that most reported neurological adverse events will be mild and self-limiting, including headache, dizziness, paresthesia, and transient fatigue-related neurological symptoms. Serious neurological complications are expected to remain uncommon. Advanced age, pre-existing neurological disorders, and multiple comorbidities may demonstrate associations with increased reporting of severe outcomes.
Conclusion: Comprehensive post-marketing surveillance is essential for maintaining public confidence in vaccination programs and identifying rare neurological complications. The proposed study is expected to contribute valuable evidence regarding the long-term neurological safety profile of the Sinopharm vaccine in diverse populations.
Keywords: Sinopharm Vaccine, Neurological Adverse Events, Pharmacovigilance
