WHO prequalifies the first vaccine against mpox

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 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 low- and middle-income country context. PQ or EUL listed products assist decision for international, regional and country procurement by UN and partner procurement agencies and member states. PQ is based on the review of full set of quality, safety and efficacy data on medical products, including risk management plan and programmatic suitability. EUL is a risk benefit assessment to address urgent demands during public health emergencies based on available limited data. Under EUL, the manufacturers are required to commit to continue generating missing information to fulfil prequalification requirements. Once this information becomes available, a PQ application should be submitted to complete the full process to achieve recommendation for international procurement in both emergency and non-emergency settings. 

WHO News

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