Author(s)
Shilanand Baban Pattebahadur, Shubham Vaidya
- Manuscript ID: 120601
- Volume 2, Issue 6, May 2026
- Pages: 463–501
Subject Area: Pharmaceutical Science and Pharmacology
DOI: https://doi.org/10.5281/zenodo.20426548Abstract
Pharmacovigilance (PV) and drug safety monitoring are essential components of healthcare systems aimed at ensuring the safe use of medicines. The primary goal of pharmacovigilance is to detect, assess, understand, and prevent adverse drug reactions (ADRs) and other drug-related problems. Continuous monitoring of medicines after their market release helps in identifying rare, delayed, or long-term side effects that may not be observed during clinical trials. The rapid development and worldwide administration of COVID-19 vaccines created an urgent need for strong global pharmacovigilance systems to monitor vaccine safety. Pharmacovigilance plays a critical role in detecting, assessing, understanding, and preventing adverse events following immunization (AEFIs). This research paper explores the global safety monitoring mechanisms established for COVID-19 vaccines and evaluates the effectiveness of international pharmacovigilance programs during the pandemic. Data from regulatory agencies, healthcare organizations, spontaneous reporting systems, and real-world evidence studies were reviewed to identify common adverse reactions, rare safety signals, and risk management strategies associated with different COVID-19 vaccines. The study highlights the contribution of organizations such as World Health Organization, national regulatory authorities, and vaccine surveillance databases in ensuring vaccine safety and maintaining public confidence. Furthermore, the paper discusses challenges including underreporting, misinformation, data inconsistency, and the need for advanced digital monitoring technologies. The findings indicate that continuous global collaboration and active pharmacovigilance significantly improved the detection of rare adverse events and supported evidence-based regulatory decisions. Strengthening international vaccine safety networks and integrating artificial intelligence with pharmacovigilance systems may enhance preparedness for future public health emergencies. This study emphasizes that effective global safety monitoring is essential for ensuring vaccine safety, improving public trust, and supporting successful immunization programs worldwide.