Pharmacovigilance in Vaccines and Biologics
Vaccines and biologics present unique pharmacovigilance challenges due to their complex structures, immune-mediated mechanisms, and wide-scale population use. Post-marketing surveillance for these products is vital to detect rare or long-term adverse events that may not be captured during pre-approval studies. Pharmacovigilance efforts must focus on passive and active surveillance systems, vaccine safety datalink (VSD) analyses, and signal detection tools tailored to biological therapies. Regulatory agencies such as the FDA and EMA mandate rigorous safety evaluations, periodic safety update reports (PSURs), and risk management plans (RMPs) specifically adapted to biologics. Transparency in communicating safety data and fostering public trust is also essential, especially in the context of vaccine hesitancy. The evolving landscape of biosimilars further demands refined pharmacovigilance strategies to assess immunogenicity and batch consistency. This session explores the integration of real-world data, post-authorization safety studies (PASS), and collaborative global safety initiatives that ensure comprehensive pharmacovigilance for vaccines and biologics.
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