The World Health Organization (WHO) announced on Monday that it has approved Bavarian Nordic’s mpox vaccine for adolescents aged 12 to 17, a demographic particularly vulnerable to outbreaks of this globally concerning disease.
The WHO stated that the Jynneos vaccine received prequalification for this age group on October 8. This approval follows the WHO’s declaration of mpox as a global public health emergency for the second time in two years, prompted by a new strain of the virus spreading from the Democratic Republic of Congo to neighboring countries.
In September, the WHO had already authorized the use of the vaccine for adults, facilitating access for severely impacted African nations. Children, adolescents, and individuals with weakened immune systems are especially susceptible to mpox, a viral infection characterized by flu-like symptoms and pus-filled skin lesions.
The recent WHO decision aligns with the European Union’s approval of the vaccine for adolescents in September. Bavarian Nordic is also planning to conduct a clinical trial to evaluate the vaccine’s safety in children aged two to 12, potentially broadening its application. This trial, which is partially funded by the Coalition for Epidemic Preparedness Innovations, is expected to begin in October.
While the U.S. Food and Drug Administration has approved Bavarian’s vaccine for adults aged 18 and older, it granted Emergency Use Authorization for adolescents during the mpox outbreak in 2022.
Additionally, another mpox vaccine, LC16, produced by Japan’s KM Biologics, is already approved for use in children, though it requires a special type of needle.
Bavarian Nordic has not yet responded to inquiries regarding the prequalification.