Explore the current approaches to conducting real-world post-authorization studies and surveillance activity for vaccines, including those conducted under the interim EMA guidance for enhanced safety surveillance for seasonal influenza vaccines.

Assessment of the safety and effectiveness of seasonal and pandemic influenza vaccines as well as other newly introduced vaccines presents different considerations and challenges than for other medical products. Widespread use in healthy populations, including children, pregnant women, and the elderly establishes high societal requirements for demonstrated benefit (effectiveness) and product safety.