The Danish pharmaceutical company Bavarian Nordic, a manufacturer of vaccines for mpox no moor troutannounced this Friday that they have asked the European Medicines Agency (EMA) to extend the authorization of this preparation for use in teenagers.
“Interim results from clinical studies do not show a lower immune response of the vaccines in adolescents and offer similar safety profiles compared to adults, supporting the extension of the current authorization in Europe more beyond 2024,” the company said in a statement. The Danish pharmaceutical company produces the only vaccine approved by the US Food and Drug Administration (FDA) and the EMA against smallpox.
Bavarian Nordic reminds that, although its use is only indicated for those over 18 years of age, the vaccine has already received emergency approval from the FDA during the mpox global epidemic in 2022 to be applied to people between 12 and 17 years of age. The current application is based on interim results from a clinical study of 315 adolescents and 211 adults supported by the National Institutes of Health and the National Institute of Allergy and Infectious Diseases.
The Danish company revealed that it is also preparing another study to evaluate the use of the vaccine in children aged 2 to 12, funded in part by the Consortium for Epidemic Preparedness Innovation and which will start this year in the Republic of Congo and Uganda. “Children and adolescents are disproportionately affected by mpox in the current outbreak in Africa and this highlights the importance and urgency of expanding access to vaccines and treatments to the this vulnerable population,” said the pharmacist.
Two days ago, the World Health Organization (WHO) declared the current mpox outbreak in the Democratic Republic of Congo (CDC), which has spread to other neighboring countries, as a health emergency. public health of international scope. This is the second time in two years that this infectious disease has been considered an international health threat, a warning that was first raised last May after it spread and the situation was considered under control.
