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 WHO website says.
The vaccine is manufactured by the Danish laboratory Bavarian Nordic A/S.
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 and review by the European Medicines Agency, the regulatory agency of record for this vaccine.
«This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future,» said WHO Director-General Dr Tedros Adhanom Ghebreyesus. «We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives.»
The MVA-BN vaccine can be administered in people over 18-years of age as a 2-dose injection given 4 weeks apart.
«The WHO prequalification of the MVA-BN vaccine will help accelerate ongoing procurement of the mpox vaccines by governments and international agencies such as GAVI and UNICEF to help communities on the frontlines of the ongoing emergency in Africa and beyond,» said Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. «The decision can also help national regulatory authorities to fast-track approvals, ultimately increasing access to quality-assured mpox vaccine products.»
On 14 August, the WHO Director-General declared the escalating mpox outbreak in the Democratic Republic of the Congo and other countries a global health emergency.
Since the start of the global outbreak in 2022, more than 103,000 cases of mpox have been confirmed in more than 120 countries. In 2024 alone, 25,237 suspected and confirmed cases and 723 deaths were reported from various outbreaks in 14 countries in the African Region.
- 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 a 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.
