WHO Authorizes First Mpox Vaccine, Citing Urgent Need Amid Global Outbreak and Criticism

The World Health Organization (W.H.O.) has granted authorization for the first vaccine designed to protect against mpox. This decision, announced with surprising haste on a Friday, took even the head of the manufacturing company, Bavarian Nordic, by surprise. The vaccine, named Jynneos, is produced by the Danish company Bavarian Nordic and has already received approval from regulatory authorities in Europe and the United States, as well as other high-income countries, following the global mpox outbreak in 2022. However, low- and middle-income countries rely on the W.H.O. to determine the safety and efficacy of drugs, vaccines, and health technologies for prequalification, through which they allocate limited health funding. Until now, the W.H.O. had declined to take action in this regard.

Criticism and Authorization

The W.H.O. faced mounting criticism for declaring a global public health emergency for mpox last month without providing a prequalification stamp of approval for the vaccine, nor a provisional form of approval such as emergency use authorization. In 2023, Bavarian Nordic submitted safety and effectiveness data for the Jynneos vaccine to the W.H.O. The organization had defended its slow pace of review, citing the need for careful study of the vaccine and its compatibility with low-resource settings like Central Africa, which involve different factors compared to high-income countries.

However, in a surprising turn of events, the W.H.O. announced the authorization of the vaccine on Friday morning. Dr. Tedros Adhanom Ghebreyesus, the W.H.O. director-general, emphasized the significance of this milestone, stating, “This first prequalification of a vaccine against mpox is an important step in our fight against the disease, both in the context of the current outbreaks in Africa, and in future.” This sudden development marks a crucial advancement in the global response to mpox, particularly in addressing the ongoing outbreaks in Africa and preventive measures for future occurrences.