Smart Vaccinovigilance for Smart Vaccines: Digital Surveillance, Real-World Evidence, and the Expanding Role of Pharm D Practitioners

Abstract

The accelerated global immunization success through the introduction of next-generation vaccines, specifically, mRNA and viral vector-based systems, has revolutionized the current practice of immunization, allowing a faster design, mass production, and response to new infectious diseases. Nevertheless, the magnitude and rate of these vaccination efforts have illuminated significant shortcomings in the conventional vaccinovigilance systems, which depends heavily on passive adverse events reporting and they are limited by under-reporting, slow signal identification, and incomplete information. This review introduces the idea of a smart vaccinovigilance, a more sophisticated model that combines digital health tools with real-life evidence to provide the opportunity to monitor vaccine safety continuously and proactively. Electronic health records, mobile health applications, wearable devices, spontaneous reporting systems, and population registries, with the help of artificial intelligence and machine learning, enable early identification of safety, automatic causality, and dynamic benefit-risk analysis. Pharm D professionals, as a growing part of active surveillance, digital pharmacovigilance, patient education, and regulatory safety reporting, are also mentioned in the review. Intelligent vaccinovigilance enhances surveillance of vaccine safety, promotes confidence in the population, and evidence-based immunization policies.