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Real-World Safety Profile of Microneedle-Array Influenza Vaccines: A Pharmacovigilance Study

Rongqiang Zhang¹, Hui Liu², Mohammad Tarique³*


Affiliations:

¹ Shaanxi University of Chinese Medicine, Xianyang 712046, China

² Lanzhou University, Lanzhou 730000, China

³ University of Missouri, Columbia 65211, USA


*Corresponding Author:Mohammad Tarique, Email:tariqueunmatched@gmail.com

Abstract

Background: While clinical trials have demonstrated the safety of microneedle array (MNA) influenza vaccines, real-world evidence remains limited. This study aimed to characterize the post-marketing safety profile of MNA influenza vaccines using spontaneous adverse event reporting system data.This large-scale pharmacovigilance study demonstrates that MNA influenza vaccines have a favorable safety profile in real-world use, characterized by predominantly mild, local application site reactions and fewer systemic adverse events compared to conventional influenza vaccines. These findings support the continued use and monitoring of MNA vaccine platforms

Keywords: Microneedle Array; Influenza Vaccine; Pharmacovigilance; Vaccine Safety; Real-World Evidence; Adverse Events

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