Pharma company seeks approval for mpox vaccine among adolescents
Danish pharmaceutical company Bavarian Nordic wants to make its vaccine against mpox available to children aged 12 to 17, it announced on Friday. The company has submitted an application to the European Medicines Agency.
Bavarian Nordic is the only pharma company that currently has a vaccine against mpox – the viral disease previously known as monkeypox – on the market. However, the vaccine, marketed in the EU under the name Imvanex, is only approved for adults, while the recent outbreak of a new, more dangerous variant also affects children.
The company has submitted data from a clinical trial in 315 adolescents and 211 adults showing that the effectiveness and side effects of the vaccine remain unchanged in young people.
It hopes to obtain approval by the last quarter of 2024. The company is also preparing a clinical trial in children aged between two and 12.
Global health emergency
On Wednesday, the World Health Organization declared a global health emergency in relation to the new, more server variant of mpox, after the African Centres for Disease Control declared it a public health emergency. The centre of the outbreak is in the Democratic Republic of the Congo, and a first case in Europe was reported in Sweden on Thursday.
Mpox spreads from animals to humans and between humans through close contact. Symptoms include rashes, flu-like symptoms and lesions. If untreated it can be deadly.
A widespread outbreak of a less harmful variant of the disease occurred in 2022, including in Europe.
Meanwhile, China announced on Friday that it was tightening its controls on people and goods that may have come into contact with the disease, with immediate effect.
People coming from countries or regions where mpox is prevalent and who have been exposed to the disease or are showing symptoms must report to customs officers upon arrival in China. Transport vehicles, containers or goods from affected areas “that are contaminated or potentially contaminated” must be decontaminated, the announcement said.
A healthcare worker in France prepares a dose of Imvanex, August 2022 © PHOTO CHRISTOPHE SIMON / AFP
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