Bavarian Nordic seeks EU’s approval to extend mpox vaccine to adolescents
Following the European Medicines Agency’ review, the vaccine’s marketing authorisation could be extended to include adolescents during the fourth quarter, the company said | Photo: Shutterstock
Danish biotech Bavarian Nordic said on Friday it had submitted data to the European Union’s drug regulator for approval to extend the use of the company’s mpox and smallpox vaccine to adolescents aged 12 to 17 years.
Mpox has been declared a global public health emergency by the World Health Organization, with children and adolescents being particularly vulnerable to the disease.
“Children and adolescents are disproportionally 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 CEO Paul Chaplin said in a statement.
Following the European Medicines Agency’ review, the vaccine’s marketing authorisation could be extended to include adolescents during the fourth quarter, the company said.
It is also preparing to conduct a clinical trial to assess the vaccine’s safety in children aged 2-12 years, potentially extending its use further.
The trial, partially funded by the Coalition for Epidemic Preparedness Innovations, is scheduled to start in the Democratic Republic of Congo and Uganda later this year, Bavarian said.
There have been 27,000 cases and more than 1,100 deaths, mainly among children, in Congo since the current outbreak began in January 2023.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
First Published: Aug 16 2024 | 12:40 PM IST
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