EU backs Bavarian Nordic mpox vaccine for adolescents after WHO approval

The European Commission has approved Bavarian Nordic's mpox vaccine for adolescents aged 12 to 17, following a positive review by the European Medicines Agency. This decision comes shortly after the World Health Organization granted approval for the vaccine's use in adults. The clinical study involved 211 adults and 312 adolescents, demonstrating a similar safety profile and non-inferiority of immune responses between the two age groups after two doses. This marks a significant step in expanding vaccine access to younger populations, particularly in light of the ongoing mpox outbreak in Africa, which has resulted in 723 deaths this year out of approximately 25,000 suspected cases. Bavarian Nordic's CEO, Paul Chaplin, emphasized the importance of this milestone in making the vaccine available to vulnerable individuals affected by the outbreak. The company is also preparing to initiate a clinical trial to evaluate the vaccine's safety and effectiveness in children aged 2 to 12, expected to start next month. This proactive approach aims to ensure that younger children are also protected against mpox, which has been a growing concern in various regions. The approval for adolescents is particularly crucial as it addresses the urgent need for vaccination in populations that are at risk. The ongoing outbreak has highlighted the vulnerability of certain demographics, and the availability of the vaccine for younger individuals is a vital step in public health efforts. As the situation evolves, the focus will remain on ensuring equitable access to vaccines for all age groups affected by mpox. In summary, the approval of the mpox vaccine for adolescents represents a significant advancement in the fight against the disease, with the potential to save lives and curb the outbreak's impact, especially in regions like Africa where the disease has been particularly devastating.