The European Union’s drug regulator has granted approval for Bavarian Nordic’s mpox vaccine to be used in adolescents aged 12 to 17, enhancing vaccination efforts during the ongoing outbreak in parts of Africa. This decision underscores the importance of immunizing younger populations, who are particularly vulnerable to the disease.
Mpox, which the World Health Organization (WHO) has declared a global public health emergency, has disproportionately affected children and adolescents. Bavarian Nordic’s vaccine, known as IMVANEX® in the EU, was initially authorized for adults but has now been expanded to include younger individuals following a swift review by the European Medicines Agency (EMA).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) based its decision on data from a clinical study involving 315 adolescents and 211 adults, which demonstrated that immune responses in adolescents matched those of adults, with a similar safety profile observed in both groups after two standard doses.
This marks the second approval for a Bavarian Nordic vaccine aimed at younger populations in the EU, following the 2020 approval of Mvabea®, a prime-boost vaccine against Ebola, which is authorized for individuals as young as one year old.
Paul Chaplin, CEO of Bavarian Nordic, hailed the EMA’s expedited review as a significant milestone. “This approval will help improve access to vaccines for some of the most vulnerable populations, particularly in Africa, where the mpox outbreak is still rampant,” he stated.
While the WHO has endorsed the off-label use of the vaccine for those under 18, this new approval solidifies its official use within the adolescent demographic across the EU. However, countries outside Europe, including the Democratic Republic of Congo (DRC), have not yet included adolescents in their initial vaccination rollouts. The DRC, currently the hardest-hit country by the outbreak, continues to face rising infection rates, reporting over 25,000 cases and more than 720 deaths across Africa this year.
Global health initiatives are stepping in to support vaccination efforts, with Gavi, the international vaccine alliance, announcing plans to purchase 500,000 doses of Bavarian Nordic’s mpox vaccine for distribution in affected regions. Additionally, a clinical study funded by the Coalition for Epidemic Preparedness Innovations (CEPI) is set to begin next month, focusing on the vaccine’s immunogenicity and safety in children aged 2 to 12.
Bavarian Nordic’s vaccine, marketed under different names globally—JYNNEOS® in the US, IMVAMUNE® in Canada, and IMVANEX® in the EU—is the only non-replicating mpox vaccine approved in several regions, including Switzerland, Singapore, Mexico, and the U.K. Originally developed for smallpox, it has shown effectiveness in controlling mpox outbreaks, particularly among high-risk populations, such as immunocompromised individuals. The company is committed to expanding access to its vaccines and is preparing to launch additional clinical studies to further extend their use to younger populations.