WHO Approves First Monkeypox Vaccine
The World Health Organization (WHO) has recently announced the addition of the MVA-BN vaccine to its prequalification list as the first vaccine against mpox. This crucial development is expected to enhance access to the vaccine in communities with an urgent need, aiding in reducing transmission and containing outbreaks.
Manufactured by the Danish laboratory Bavarian Nordic A/S, the MVA-BN vaccine has received prequalification approval, streamlining the process for communities to obtain the vaccine promptly. WHO’s assessment for prequalification was based on information provided by the manufacturer and reviewed by the European Medicines Agency.
Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO, emphasized the significance of this milestone in combating the disease, emphasizing the need for scaling up procurement, donations, and rollout to ensure equitable access to vaccines where they are most needed. The MVA-BN vaccine is designed for individuals over 18 years old and requires a two-dose injection given four weeks apart.
Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, highlighted that the prequalification of the MVA-BN vaccine will accelerate the procurement of mpox vaccines by governments and international agencies to support communities affected by the outbreak in Africa and beyond.
With the global outbreak of mpox escalating, WHO declared it a global health emergency on August 14. Since the beginning of the outbreak in 2022, over 103,000 cases of mpox have been confirmed in more than 120 countries. In 2024 alone, there were 25,237 suspected and confirmed cases, resulting in 723 deaths in 14 countries in the African Region.
WHO Prequalification (PQ) and Emergency Use Listing (EUL) play a critical role in evaluating the quality, safety, and efficacy of medical products like vaccines. These mechanisms help facilitate international, regional, and country procurement decisions, supporting efforts to combat global health crises effectively.
