Bavarian Nordic, the Danish pharmaceutical company, is seeking European regulatory approval to extend the use of its mpox vaccine to adolescents aged 12 to 17. This move comes in response to the World Health Organization’s (WHO) recent declaration of a global public health emergency following a surge in a new, more virulent strain of the mpox virus.
The WHO’s emergency designation this week highlighted the rapid spread of Clade 1b, a concerning new variant of mpox. This strain has been classified as a public health emergency of international concern (PHEIC), the highest level of alert issued by the UN agency.
Currently, Bavarian Nordic’s vaccine is approved for use only in individuals 18 years and older. However, with the escalating threat posed by Clade 1b, the company has submitted a request to the European Medicines Agency (EMA) to expand the vaccine’s approval to include adolescents.
The company has provided the EMA with clinical data from recent studies that demonstrate the vaccine’s effectiveness in adolescents. The data show that the immune response elicited by the mpox/smallpox vaccine in teenagers is non-inferior to that observed in adults, and the safety profile is comparable between the two age groups.
Mpox, a disease caused by a virus transmitted from animals to humans and capable of human-to-human transmission through close contact, manifests with symptoms such as fever, muscular aches, and distinctive large boil-like skin lesions.
The recent surge in cases, driven by the Clade 1b variant, has raised concerns about a potential increase in transmission rates and severity of illness, particularly among younger populations.
Bavarian Nordic’s request reflects growing global concern over the spread of mpox and the need for expanded vaccination strategies to protect vulnerable populations, including adolescents who may be at higher risk during outbreaks.
The EMA’s decision on the application is anticipated to play a crucial role in the broader public health response to the current mpox crisis.