The World Health Organization (WHO) has officially prequalified the MVA-BN vaccine as the first vaccine against mpox, marking a significant milestone in global public health efforts to combat the ongoing outbreaks.

⁰The prequalification approval will streamline the vaccine’s availability in areas hardest hit by mpox, particularly in Africa, and facilitate timely procurement through global health agencies like Gavi and UNICEF.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, called the move an “important step” in the fight against mpox, emphasizing the urgent need for increased vaccine distribution to curb transmission and save lives.

“We now need urgent scale-up in procurement, donations, and rollout to ensure equitable access to vaccines,” Ghebreyesus said.

The MVA-BN vaccine, manufactured by Bavarian Nordic, has been rigorously assessed by the WHO, based on information from the company and a review by the European Medicines Agency (EMA).

It is approved for use in individuals over 18 years old, administered as a two-dose injection four weeks apart. The vaccine is stable at 2–8°C for up to eight weeks, making it suitable for distribution in areas with limited cold chain infrastructure.

While the vaccine has shown high efficacy—up to 82% with the two-dose regimen—WHO’s Strategic Advisory Group of Experts (SAGE) recommends its use in individuals at high risk during outbreaks, especially in high-transmission areas. In certain outbreak situations with supply constraints, a single-dose administration may be used.

“We are progressing with prequalification and emergency use listing procedures with manufacturers of two other mpox vaccines, LC-16 and ACAM2000,” said Dr. Rogerio Gaspar, WHO Director for Regulation and Prequalification.

This move is part of WHO’s broader efforts to combat the escalating mpox crisis, which has seen more than 103,000 cases worldwide since the outbreak began in 2022. In 2024 alone, Africa has recorded over 25,000 suspected and confirmed cases.

The WHO’s decision follows the declaration of a Public Health Emergency of International Concern (PHEIC) in August 2024 due to the upsurge of cases in the Democratic Republic of the Congo and other African nations.

As the virus continues to spread, the prequalification of the MVA-BN vaccine is expected to provide a critical tool in reducing transmission and mitigating the impact of the disease globally.