Geneva: The prequalification follows a thorough assessment by WHO and the European Medicines Agency based on data provided by Bavarian Nordic A/S, the vaccine’s manufacturer. WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasized the significance of this step in the context of the current outbreaks in Africa and the future. He now calls for an urgent need to increase procurement, donations and rollout to ensure equitable access.
The MVA-BN vaccine, administered in two doses spaced four weeks apart, is authorized for adults over 18. It has been shown to achieve 82% effectiveness after the full two-dose regimen, while a single-dose, recommended in supply-constrained areas, provides about 76% effectiveness.
Dr. Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, stressed that the prequalification will speed up vaccine procurement by international agencies like Gavi and UNICEF.
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The ongoing mpox outbreak, particularly in the Democratic Republic of the Congo and other African nations, was declared a Public Health Emergency of International Concern (PHEIC) in August 2024, after surges in cases across the region. WHO continues to push for further research on the safety and effectiveness of vaccines like MVA-BN, particularly in outbreak settings where rapid immunization is essential.
With over 103,000 confirmed cases worldwide since the global outbreak began in 2022, and nearly 25,237 suspected and confirmed cases reported in 2024 alone, the MVA-BN vaccine could play a critical role in turning the tide against thee virus.





