WHO Prequalifies First Vaccine Against Mpox

The World Health Organization (WHO) has added the MVA-BN vaccine to its prequalification list as the first approved vaccine for mpox. This prequalification aims to ensure timely and expanded access to the vaccine in areas with urgent needs, reducing transmission and containing the outbreak effectively. The approval follows an assessment based on information from the manufacturer, Bavarian Nordic A/S, and a review by the European Medicines Agency (EMA), the regulatory authority for this vaccine.

“This prequalification of a vaccine against mpox marks a significant milestone in our battle against the disease, both in current outbreaks in Africa and in future scenarios,” said WHO Director-General Dr. Tedros Adhanom Ghebreyesus. “We urgently need to scale up procurement, donations, and distribution to ensure equitable vaccine access, alongside other public health measures to prevent infections, halt transmission, and save lives.”

The MVA-BN vaccine is administered in two doses, four weeks apart, to individuals over 18 years of age. It can be stored at 2–8°C for up to 8 weeks after initial cold storage.

“The WHO prequalification of the MVA-BN vaccine will accelerate procurement efforts by governments and international agencies like Gavi and UNICEF, supporting frontline communities in Africa and beyond,” stated Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “This decision also aids national regulatory authorities in fast-tracking approvals, thus increasing access to quality-assured mpox vaccines.”

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization reviewed all available evidence and recommended the MVA-BN vaccine for use during mpox outbreaks in high-risk individuals. Although currently not licensed for those under 18, the vaccine may be used “off-label” in infants, children, adolescents, pregnant, and immunocompromised individuals where the benefits outweigh the risks.

WHO also advises single-dose use in outbreak situations with limited supply and emphasizes the need for further data on vaccine safety and effectiveness under these conditions.

Data shows that a single-dose MVA-BN vaccine offers about 76% protection against mpox if administered before exposure, while the two-dose regimen provides approximately 82% effectiveness. Post-exposure vaccination is less effective.

The vaccine’s safety profile and effectiveness have been consistently demonstrated in clinical trials and real-world usage during the ongoing outbreak since 2022. Given the evolving epidemiology and emergence of new virus strains, ongoing data collection on the vaccine’s safety and efficacy is crucial.

Following the emergency use listing triggered by WHO on August 7, 2024, WHO has assessed the MVA-BN vaccine’s product and programmatic suitability. “These assessments are crucial in the context of the public health emergency declared due to the rise in mpox cases in Africa,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification. “We are also progressing with prequalification and emergency use listings for other mpox vaccines, such as LC-16 and ACAM2000, and have received expressions of interest for mpox diagnostic products.”

The escalating mpox outbreak in the Democratic Republic of the Congo and other countries was declared a Public Health Emergency of International Concern (PHEIC) on August 14, 2024. Over 120 countries have reported more than 103,000 mpox cases since the global outbreak began in 2022. In 2024 alone, there were 25,237 suspected and confirmed cases and 723 deaths from various outbreaks in 14 African countries (data as of September 8, 2024).

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