WHO approves Bavarian Nordic's mpox vaccine for adolescents

October 14, 2024
The World Health Organization (WHO) has approved Bavarian Nordic's mpox vaccine, Jynneos, for adolescents aged 12 to 17. This decision, made on October 8, addresses a vulnerable age group in the ongoing mpox outbreak. The WHO declared mpox a global health emergency in August due to a new strain spreading from the Democratic Republic of Congo. The vaccine was previously approved for adults in September. Bavarian Nordic is now preparing to test the vaccine's safety in children aged 2 to 12. The U.S. FDA has approved Jynneos for adults and granted Emergency Use Authorization for adolescents.
The World Health Organization (WHO) has taken a significant step in addressing the global mpox outbreak by approving Bavarian Nordic's Jynneos vaccine for adolescents aged 12 to 17. This decision, announced on October 8, 2024, comes in response to the particular vulnerability of this age group to mpox outbreaks.
The approval follows the WHO's declaration of mpox as a global public health emergency in August, prompted by the spread of a new type of the virus from the Democratic Republic of Congo to neighboring countries. This marks the second time in two years that mpox has been designated as such an emergency.
The Jynneos vaccine had already received WHO prequalification for use in adults in September, a move aimed at facilitating access to the vaccine in African countries severely affected by the outbreak. The extension of approval to adolescents is particularly crucial given that children, adolescents, and individuals with weakened immune systems are especially susceptible to mpox, which typically causes flu-like symptoms and pus-filled skin lesions.
This WHO decision aligns with the European Union's approval of the vaccine for adolescents in September. Bavarian Nordic is now preparing to conduct a clinical trial, partially funded by the Coalition for Epidemic Preparedness Innovations, to assess the vaccine's safety in children aged 2 to 12. This trial, expected to begin in October, could potentially lead to further expansion of the vaccine's use.
In the United States, the Food and Drug Administration (FDA) has approved the Jynneos shot for adults 18 and older. However, during the 2022 mpox outbreak, the FDA granted Emergency Use Authorization for its use in adolescents.
These developments represent significant progress in the global effort to combat mpox, offering protection to a broader range of age groups and potentially curbing the spread of the virus in vulnerable populations.
