W.H.O. Approves First Vaccine for Mpox Amid Global Health Concerns

World Health Organization Approves First Vaccine for Mpox

The World Health Organization (W.H.O.) has made a significant breakthrough by granting authorization for the first vaccine to combat mpox, a decision that was announced with surprising urgency on Friday, catching even the CEO of the manufacturing company off guard. The vaccine, developed by the Danish company Bavarian Nordic, has already received approval from regulatory authorities in Europe, the United States, and several other high-income nations following a global outbreak of mpox in 2022.

However, for low- and middle-income countries, the W.H.O. plays a crucial role in determining which medications, vaccines, and health technologies are deemed safe and effective. This evaluation process, known as prequalification, is essential for these nations as they navigate the challenges of limited healthcare funding. Until now, the W.H.O. had refrained from acting, despite increasing criticism for declaring mpox a global public health emergency last month without providing the vaccine with the necessary prequalification stamp of approval or even an emergency use authorization.

Bavarian Nordic initially submitted its data regarding the vaccine’s safety and efficacy, named Jynneos, to the W.H.O. in 2023. The organization, defending its slower review process, emphasized the need for thorough evaluation due to the vaccine’s original design as a smallpox immunization. Moreover, they highlighted the complexities of administering the vaccine in low-resource settings, such as Central Africa, which differ significantly from conditions in wealthier countries.

In an unexpected announcement on Friday morning, the W.H.O. declared its approval of the vaccine. “This first prequalification of a vaccine against mpox is a crucial step in our battle against the disease, especially in light of the ongoing outbreaks in Africa and for future prevention,” stated Dr. Tedros Adhanom Ghebreyesus, the director-general of the W.H.O.

Paul Chaplin, the chief executive of Bavarian Nordic, expressed his surprise at the rapid decision. “We’ve reached this milestone eventually — I’m not entirely sure how,” he remarked. “But it’s undoubtedly good news. This will streamline the regulatory pathway significantly.”