Monkeypox: Bavarian Nordic applies for registration of vaccine for adolescents
Kyiv • UNN
Bavarian Nordic has submitted clinical data to the EMA to extend the approval of its monkeypox vaccine to adolescents aged 12-17. This is due to the epidemic in Africa, where children and adolescents are disproportionately affected by the virus.
The Bavarian Scandinavian company hopes that the European Medicines Agency (EMA) will approve a smallpox vaccine for children aged 12 to 17.
Writes UNN with reference to Avisen Danmark.
Details
Leading Danish biotechnology company Bavarian Nordic has submitted clinical data to the European Medicines Agency (EMA) to expand the approval of its monkeypox vaccine (Mpox).
Interim results of the clinical trial indicate no differences in immune responses to smallpox and smallpox vaccine in adolescents and a safety profile similar to that of adults
Currently, the use of the vaccine is limited to adults, according to the Handelsblatt newspaper. However, according to Bavarian Nordic CEO Paul Chaplin, the company is seeking to expand the scope of the vaccine to 12-17-year-olds.
“Children and adolescents are disproportionately affected by chickenpox during the ongoing epidemic in Africa, underscoring the importance and urgency of expanding access to vaccines and treatment for this vulnerable population,” Paul Chaplin, CEO of Bavarian Nordic, said in a statement.
Recall
The African Union Health Agency has declared a "public health emergency" due to the smallpox epidemicthat has swept the continent.
At present, the strong rebound of the disease in Africa is mainly due to a new strain, clade 1b, which is more contagious and dangerous than the previous ones.
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