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In the wake of the fast-spreading mpox outbreak, the World Health Organization (WHO) has announced that a vaccine named ‘MVA-BN’ will be the first vaccine against mpox to be added to its prequalification list.
The prequalification approval will facilitate timely and increased access to the vaccine for communities with urgent need, to reduce transmission and help contain the outbreak.
WHO’s assessment for prequalification is based on the information provided by the manufacturer, Bavarian Nordic A/S, and further review by the European Medicines Agency, the regulatory agency that oversaw the development 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,” WHO Director-General Tedros Adhanom Ghebreyesus was quoted in a press statement.
“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,” he added.
The MVA-BN vaccine can be administered in people over 18-years of age as a two-dose injection which is given 4 weeks apart. After prior cold storage, the vaccine can be kept at 2–8°C for up to eight weeks.
“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,” she added.
The WHO Strategic Advisory Group of Experts (SAGE) reviewed the available evidence and recommended the use of MVA-BN vaccine in the context of an mpox outbreak for persons at high risk of exposure.
The WHO also recommends single-dose use in supply-constrained outbreak situations and emphasises the need to collect further data on vaccine safety and effectiveness in these circumstances.
The UN body mentioned in the press statement that a single-dose MVA-BN vaccine given before exposure has an estimated 76 per cent effectiveness in protecting people against mpox, with the two-dose schedule achieving an estimated 82 per cent effectiveness.
Since the triggering of the emergency use listing for mpox vaccines by WHO Director-General on August 7 2024, WHO has conducted product and programmatic suitability assessments of MVA-BN vaccine.
“The findings of the assessments are particularly relevant in the context of the declaration of a public health emergency of international concern (PHEIC) related to the upsurge of mpox in Africa,” said Rogerio Gaspar, WHO Director for Regulation and Prequalification.
“We are progressing with prequalification and emergency use listing procedures with manufacturers of two other mpox vaccines: LC-16 and ACAM2000. We have also received 6 expressions of interest for mpox diagnostic products for emergency use listing so far,” he added.
So far, more than 120 countries have confirmed more than 103, 000 cases of mpox since the onset of the global outbreak in 2022. In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from different outbreaks in 14 countries of the African region.