EU approves Bavarian Nordic's mpox vaccine for adolescents

Mpox, declared a global public health emergency by WHO, has disproportionately affected children and adolescents

The European Union’s drug regulator has approved Bavarian Nordic's mpox vaccine for use in adolescents aged 12 to 17, expanding its availability amid the ongoing outbreak in parts of Africa.

This approval strengthens the case for broader immunization efforts in younger populations who are particularly vulnerable to the disease.

Mpox, declared a global public health emergency by the World Health Organization (WHO), has disproportionately affected children and adolescents.

Bavarian Nordic’s vaccine, branded as IMVANEX® in the EU, was initially approved for adults but has now received authorization for younger individuals after 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.

The results demonstrated that immune responses in adolescents were on par with adults, with a similar safety profile observed across both groups after receiving two standard doses of the vaccine.

This marks the second approval of a Bavarian Nordic vaccine for younger populations in the EU, following the approval of Mvabea® in 2020, a prime-boost vaccine against Ebola.

That vaccine was approved for individuals as young as one year old, supported by studies involving over 3,300 people, including 800 children and adolescents across Europe, the US, and Africa.

Paul Chaplin, CEO of Bavarian Nordic, praised the EMA’s expedited review, calling the decision an important 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 said.

While the WHO has endorsed the off-label use of the vaccine for individuals under 18, this approval solidifies its official use in the adolescent population across the EU.

However, countries outside of Europe, like the Democratic Republic of Congo (DRC), have yet to include adolescents in their initial vaccination rollouts. The DRC, the country worst-hit by the current outbreak, continues to struggle with rising infection rates, with over 25,000 cases and more than 720 deaths reported across Africa this year.

Global health initiatives are also stepping in to support vaccination efforts. The international vaccine alliance Gavi announced plans to purchase 500,000 doses of Bavarian Nordic's mpox vaccine to distribute in affected regions.

Meanwhile, a clinical study funded by the Coalition for Epidemic Preparedness Innovations (CEPI) is set to begin next month, assessing the vaccine's immunogenicity and safety in children aged 2 to 12.

Bavarian Nordic's vaccine, branded under different names in various countries—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.

Initially developed for smallpox, it has proven effective in curbing mpox outbreaks, particularly in populations at higher risk, 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.