The Danish pharmaceutical company, Bavarian Nordic, has announced its intention to seek approval from European authorities to use its mpox vaccine in adolescents between the ages of 12 and 17.
This decision was made following the World Health Organization’s declaration of a global public health emergency caused by the rapid spread of a more dangerous strain of mpox known as Clade 1b.
NAIJATRAFFIC had previously reported on the WHO’s warning about the mpox outbreak in Africa becoming a global public health emergency.
The WHO convened a meeting of experts to assess the situation and advise the UN health agency’s director-general, Tedros Adhanom Ghebreyesus.
Tedros confirmed the emergency committee’s recommendation that the situation is a public health emergency of international concern.
Currently, Bavarian Nordic’s mpox vaccine is only approved for individuals aged 18 and older, but CEO Paul Chaplin stressed the importance of expanding vaccine eligibility to younger age groups.
“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,” Chaplin noted in a statement.
The company said it had presented the European Medicines Agency with clinical data from a study that showed “non-inferiority of immune responses from mpox/smallpox vaccination in adolescents and (a) similar safety profile compared to adults.”
The US Food and Drug Administration granted emergency use authorization for the mpox vaccine for adolescents during the 2022 outbreak .
However, the virus continues to spread globally, with recent cases reported in Sweden and Pakistan, marking the first instances outside Africa .
The World Health Organization warns of additional imported cases in Europe, and the outbreak has had severe consequences in Africa, particularly in the Democratic Republic of Congo, where mpox has claimed 548 lives this year .
The virus causes fever, muscle aches, and large boil-like skin lesions, and is transmitted from animals to humans and through close human contact .
With the escalation of the mpox outbreak and the emergence of the Clade 1b strain, the need for expanded vaccine availability and proactive health measures has never been more pressing.
