Danish pharmaceutical company Bavarian Nordic has applied for European approval to extend the use of its mpox vaccine to children aged 12 to 17. This move comes in response to the World Health Organization’s (WHO) declaration of a global public health emergency due to the rapid spread of a new, more dangerous strain of the mpox virus, known as Clade 1b.
Currently, Bavarian Nordic’s vaccine is approved for individuals aged 18 and older. However, the company’s CEO, Paul Chaplin, highlighted the urgency of expanding vaccine access to younger populations, noting that children and adolescents have been disproportionately affected by the ongoing outbreak in Africa.
The company has submitted clinical data to the European Medicines Agency (EMA) showing that the immune responses in adolescents are comparable to those in adults, and that the vaccine’s safety profile is similar across age groups.
In addition to seeking European approval, Bavarian Nordic’s vaccine has already received “emergency use authorization” from the US Food and Drug Administration (FDA) for adolescents during the 2022 global mpox outbreak.
The virus has caused significant outbreaks in the Democratic Republic of Congo, with 548 deaths reported this year alone. Recently, Sweden and Pakistan have identified cases of the virus outside Africa, with the WHO anticipating further imported cases in Europe.
Mpox, transmitted to humans from animals and through close physical contact, leads to symptoms such as fever, muscle aches, and large, boil-like skin lesions.
Bavarian Nordic also announced its readiness to produce up to 10 million vaccine doses by 2025, pending orders from countries.
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