WHO prequalifies the first vaccine against mpox
The World Health Organization (WHO) has announced the MVA-BN vaccine as the first vaccine against mpox to be added to its prequalification list. The prequalification approval is expected to facilitate timely and increased access to this vital product in communities with urgent need, to reduce transmission and help contain the outbreak. WHO’s assessment for prequalification is based on information submitted by the manufacturer, Bavarian Nordic A/S, and review by the European Medicines Agency, the regulatory agency of record for this vaccine. The MVA-BN vaccine can be administered in people over 18-years of age as a 2-dose injection given 4 weeks apart. After prior cold storage, the vaccine can be kept at 2–8°C for up to 8 weeks. WHO Prequalification (PQ) and Emergency Use Listing (EUL) are mechanisms used to evaluate quality, safety and efficacy of medical products, such as vaccines, diagnostics and medicines (optional: including biotherapeutics), and product suitability for use in an