WHO Adds First Mpox Vaccine To Prequalification List

The World Health Organization (WHO) has officially added the MVA-BN vaccine to its prequalification list, marking a significant milestone in the fight against mpox. This vaccine, developed by Bavarian Nordic A/S, is the first to receive such prequalification status for mpox, which is expected to improve access and distribution in regions facing outbreaks.

Prequalification by WHO involves evaluating the quality, safety, and efficacy of medical products to ensure they meet international standards and are suitable for use in low- and middle-income countries. The MVA-BN vaccine’s prequalification is based on data reviewed by the European Medicines Agency, which confirms its readiness for broader deployment.

WHO Director-General Dr. Tedros Adhanom Ghebreyesus emphasized that this approval is a crucial step in combating the current mpox outbreaks in Africa and preparing for future ones. He highlighted the need for increased procurement, donations, and rollout to ensure the vaccine reaches those in need.

The MVA-BN vaccine is administered in two doses, four weeks apart, and can be stored at 2-8 degrees Celsius for up to eight weeks. It has shown an estimated 76% effectiveness with a single dose and 82% with the two-dose schedule. While currently not licensed for individuals under 18, it may be used off-label for infants, children, and pregnant or immunocompromised individuals in outbreak settings, pending further safety data.

Since the global outbreak began in 2022, over 120 countries have reported more than 103,000 cases of mpox, with significant numbers in 14 African nations. The WHO has previously declared the outbreak a public health emergency of international concern.