The World Health Organization (WHO) announced on Monday that it has approved Bavarian Nordic’s mpox vaccine, Jynneos, for use in adolescents aged 12 to 17 years, a group considered particularly vulnerable to outbreaks. The approval, granted on October 8, aims to address rising global concern about the spread of the disease.
Mpox, a viral infection that causes flu-like symptoms and skin lesions, was declared a global public health emergency by the WHO in August after a new strain spread from the Democratic Republic of Congo to neighboring countries. Previously, the vaccine had been approved for adults, with the goal of improving access in severely affected regions, particularly in Africa.
The decision to approve the vaccine for adolescents follows the European Union’s approval in September, and Bavarian Nordic is preparing for a clinical trial to assess the vaccine’s safety in children aged two to 12. The trial, partly funded by the Coalition for Epidemic Preparedness Innovations, is expected to begin in October.
While the U.S. Food and Drug Administration has approved the vaccine for adults, it granted Emergency Use Authorization for adolescents during the 2022 mpox outbreak. Meanwhile, Japan’s KM Biologics produces another mpox vaccine, LC16, which is already authorized for children in Japan.
Bavarian Nordic has not yet commented on the WHO prequalification.
