Breakthrough in Mpox Fight: WHO Approves First Vaccine

The World Health Organization (WHO) has made a significant stride in combating the mpox (formerly monkeypox) outbreak by prequalifying the MVA-BN vaccine. This milestone approval marks the first vaccine against mpox to receive WHO’s prequalification, paving the way for improved access to the vaccine in communities facing urgent needs.

A Crucial Step Forward

WHO’s Director-General, Dr. Tedros Adhanom Ghebreyesus, emphasized the significance of this development, stating that prequalification represents an essential step in controlling mpox outbreaks in Africa and globally. The approval is based on a thorough review of data submitted by Bavarian Nordic A/S, the vaccine’s manufacturer, and the European Medicines Agency.

Key Benefits of Prequalification

The MVA-BN vaccine’s prequalification is expected to:

1. Enhance access to the vaccine for high-risk groups.
2. Accelerate procurement by governments and international organizations.
3. Benefit communities affected by the mpox outbreak.
   

Vaccine Details

The MVA-BN vaccine:

1. Is approved for adults aged 18 and over.
2. Administered as a two-dose injection, four weeks apart.
3. Can be stored at 2–8°C for up to eight weeks after removal from cold storage.
   

WHO Recommendations

The WHO’s Strategic Advisory Group of Experts (SAGE) on Immunization recommends the MVA-BN vaccine for:

1. High-risk groups in mpox outbreak contexts.
2. Off-label use for children, pregnant women, and immunocompromised individuals where benefits outweigh risks.
3. Single-dose administration in cases of limited supply.
   

Data-Driven Decision-Making

Studies demonstrate that:

1. A single dose provides 76% protection against mpox.
2. The two-dose regimen increases effectiveness to 82%.
3. Vaccination after exposure is less effective.

Ongoing Efforts

WHO continues to assess other mpox vaccines, including LC-16 and ACAM2000, and six diagnostic products for emergency use.

The Mpox Outbreak

Since 2022, over 120 countries have reported more than 103,000 mpox cases. In 2024, 25,237 suspected and confirmed cases have been reported, with 723 deaths across 14 countries in the African region.

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