WHO Approves World's First Mpox Vaccine for Use in Selected Areas

Photo : Reuters

New Delhi: The World Health Organization (WHO) has announced the MVA-BN vaccine as the first mpox vaccine to receive prequalification status. This move is expected to improve access to this crucial vaccine in communities experiencing urgent needs, aiming to curb transmission and manage outbreaks effectively, according to a statement on WHO’s website.

The WHO’s 'prequalification' and 'emergency use listing' mechanisms are designed to assess the quality, safety, and efficacy of medical products, including vaccines, diagnostics, and medicines. These evaluations ensure that products meet international standards and are suitable for use in low- and middle-income countries.

The prequalification of the MVA-BN vaccine was based on data submitted by the manufacturer, Bavarian Nordic A/S, which was reviewed by the European Medicines Agency, the regulatory authority responsible for the vaccine.

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In response to this development, WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasized the significance of this milestone. "The first prequalification of a vaccine against mpox represents a crucial advance in our efforts to combat the disease, both in the context of the ongoing outbreaks in Africa and for future preparedness," he stated. Dr. Ghebreyesus highlighted the urgent need for scaling up procurement, donations, and distribution to ensure equitable vaccine access. This, alongside other public health measures, is essential for preventing infections, halting transmission, and saving lives.

The MVA-BN vaccine is approved for use in individuals aged 18 and older, administered as a two-dose series with an interval of four weeks. After initial cold storage, the vaccine can be maintained at a temperature of 2-8°C for up to eight weeks.

The WHO Strategic Advisory Group of Experts (SAGE) on Immunization reviewed the available evidence and recommended the MVA-BN vaccine for use in mpox outbreak situations among individuals at high risk of exposure. While the vaccine is not currently licensed for use in those under 18 years of age, it may be used "off-label" for infants, children, adolescents, pregnant women, and immunocompromised individuals in outbreak settings where the benefits are deemed to outweigh potential risks. The WHO has stressed the importance of gathering additional data on the vaccine’s safety and effectiveness in these groups.

Data shows that the MVA-BN vaccine has an estimated 76% effectiveness with a single dose administered before exposure, and approximately 82% effectiveness with the complete two-dose regimen. Effectiveness is notably lower when the vaccine is administered post-exposure.

The WHO had previously declared the escalating mpox outbreak in the Democratic Republic of the Congo and other affected countries a public health emergency of international concern on August 14. Since the global outbreak began in 2022, over 120 countries have reported more than 103,000 cases. In 2024 alone, there have been 25,237 suspected and confirmed cases, with 723 deaths across 14 African nations.

The prequalification of the MVA-BN vaccine marks a significant step in controlling the mpox outbreak and enhancing global health security.