Mpox, recently declared a global public health emergency by the World Health Organization (WHO), poses a significant threat to children and adolescents, who are particularly vulnerable to the disease.
In response to this growing concern, Danish biotech company Bavarian Nordic announced on Friday that it has submitted data to the European Union’s drug regulator seeking approval to extend the use of its mpox and smallpox vaccine to adolescents aged 12 to 17 years.
The urgency of this request is underscored by recent developments in global health. On Thursday, officials confirmed a new strain of the mpox virus in Sweden, linking it to a burgeoning outbreak in Africa, signaling the virus’s spread beyond the continent.
“Children and adolescents are disproportionately affected by mpox in the ongoing outbreak in Africa,” Bavarian Nordic CEO Paul Chaplin stated. “This highlights the importance and urgency of broadening access to vaccines and therapies for this vulnerable population.”
The European Medicines Agency’s (EMA) review of the submitted data could lead to an extension of the vaccine’s marketing authorization to include adolescents by the fourth quarter of this year. Additionally, Bavarian Nordic is preparing to conduct a clinical trial to assess the vaccine’s safety in children aged 2 to 12 years, potentially broadening its use further.
This upcoming trial, partly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is set to begin later this year in the Democratic Republic of Congo and Uganda.
Since the current outbreak began in January 2023, the Democratic Republic of Congo has reported 27,000 cases and more than 1,100 deaths, primarily among children.
