Executive Summary of WHO Informal Consultation on the Standardization of Biological Products for Mpox and other Emerging Pathogens

Overview

Recent resurgence and cross-regional transmission of Mpox (formerly known as monkeypox), particularly in Africa, have underscored the importance of strengthening global and regional preparedness for emerging pathogens. While vaccines and therapeutics originally developed for smallpox are currently being used for Mpox, Mpox-specific biological products remain limited, and reference standards, widely validated assays, and broader regulatory experience are not yet fully established to support consistent evaluation and use. To address these gaps and to facilitate the availability of safe, effective, and quality-assured biological products, a WHO informal consultation on the standardization of biological products for Mpox and other emerging pathogens was held in Tunis, Tunisia, from 24 to 25 November 2025. The detailed agenda is attached to this summary.