The World Health Organization (WHO) announced on Monday that it has approved the Bavarian Nordic’s Jynneos vaccine for adolescents aged 12 to 17 years, a demographic identified as particularly vulnerable to mpox outbreaks.
The decision, reported today by Reuters, follows the WHO’s August announcement of a renewed global public health emergency due to mpox. The move aims to widen access to the vaccine amid rising concerns over the viral infection.
According to the news service, the WHO’s prequalification for the Jynneos vaccine (MVA-BN) was approved on Oct. 8. The vaccine was initially authorized for adult use last month, facilitating access for African countries significantly impacted by mpox.
WHO prequalification verifies that crucial medicines meet the organization’s standards for quality, safety, and effectiveness. This process aids National Regulatory Authorities, particularly in regions like Africa where resources are limited, by simplifying their task of approving medications.
Mpox, characterized by flu-like symptoms and painful lesions, emerged as a global concern when a new strain spread from the Democratic Republic of Congo to neighboring countries. Children, adolescents, and people with weakened immune systems are at a higher risk for severe illness.
In addition to the WHO’s recent approval, the EU recommended the use of the Jynneos vaccine for adolescents in September. Bavarian Nordic is preparing to conduct a clinical trial to assess the vaccine’s safety in children aged 2 to 12, partially funded by the Coalition for Epidemic Preparedness Innovations, a global partnership working to speed development of vaccines and other countermeasures against epidemic and pandemic threats. The trial is expected to begin in October.
“We applaud EMA [European Medicines Agency] for their expedited review and decision to recommend approval of MVA-BN for adolescents,” Paul Chaplin, president and chief executive officer of Bavarian Nordic, said in a statement. “This represents an important milestone in our efforts to make our vaccine available for all populations and will help improve access for some of the most vulnerable individuals mostly impacted by the ongoing mpox outbreak in Africa.”
While the U.S. Food and Drug Administration approved the Jynneos vaccine for adults 18 and older in May, it allowed an Emergency Use Authorization for adults at higher risk during the mpox outbreak in 2022. In Japan, another Mpox vaccine, LC16, developed by KM Biologics, has been approved for administration to children.
As the global response to Mpox continues to evolve, health officials state the importance of vaccination in curbing the spread and protecting vulnerable populations.