Mpox vaccine maker seeks approval for use in teens
The Peninsula
Copenhagen: Danish drugmaker Bavarian Nordic said Friday it was seeking European approval to use its mpox vaccine in children aged 12 to 17, after the...
Copenhagen: Danish drugmaker Bavarian Nordic said Friday it was seeking European approval to use its mpox vaccine in children aged 12 to 17, after the WHO declared the current virus surge a global public health emergency.
The World Health Organization (WHO) this week declared the rapid spread of the new, more dangerous mpox strain, dubbed Clade 1b, a public health emergency of international concern -- the highest alarm the UN agency can sound.
Bavarian Nordic's vaccine is currently only approved for people 18 years and older.
"Children and adolescents are disproportionately affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to vaccines and therapies for this vulnerable population," Bavarian Nordic chief executive Paul Chaplin said in a statement.
The company said it had presented the European Medicines Agency with clinical data from a study which showed "non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and (a) similar safety profile compared to adults."