Danish Bavarian Nordic has submitted an application for expanded use of the company’s mpox vaccine so that it can also be given to young people aged 12-17.
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The outbreak of the new variant of mpox, which caused the WHO to issue a global health emergency, seems to hit children and young people particularly hard. But currently, Bavarian’s vaccine Imvanex, the only mpox vaccine approved by both the EMA and the FDA, can only be given to people aged 18 and over.
Now the company has submitted clinical data to the European Medicines Agency EMA to get the vaccine approved for the 12-17 age group as well, according to a press release.
– Children and young people are disproportionately affected by mpox in the ongoing outbreak in Africa, which underlines the importance and urgency of broadening access to vaccines and therapies for this vulnerable population, says Paul Chaplin, president and CEO of Bavarian Nordic, in a press release.
The application is based on interim results from a clinical study with 315 young people aged 12-17 and 211 adults aged 18 and over, which, according to the company, shows that the immune response is not worse in the younger group and the safety profile is similar after vaccination with two standard doses of the vaccine .
Bavarian expects an extended approval to come in the last quarter of this year.
In connection with the previous mpox outbreak in 2022, the vaccine received an emergency approval by the US FDA for use in adolescents.
Bavarian is also preparing a clinical study to test the immune response and safety profile of the vaccine in children aged 2-12 years with the aim of further expanding the indication.
