Manufacturer of Mpox vaccine applies for approval for use in teenagers

Danish pharmaceutical company Bavarian Nordic said on Friday that it was seeking European approval for the use of its Mpox vaccine in children aged 12 to 17, after the WHO declared the current virus wave a global public health emergency.

The World Health Organization (WHO) this week declared the rapid spread of the new, more dangerous Mpox strain, called Clade 1b, an international health emergency – the highest level of alert that the UN agency can issue.

The Bavarian Nordic vaccine is currently only approved for people aged 18 and over.

“In the ongoing outbreak in Africa, children and adolescents are disproportionately affected by Mpox, underscoring the importance and urgency of expanding access to vaccines and therapies for this vulnerable population,” Paul Chaplin, managing director of Bavarian Nordic, said in a statement.

The company said it had submitted clinical data from a study to the European Medicines Agency showing “non-inferiority of immune responses to smallpox vaccination in adolescents and a similar safety profile to that seen in adults.”

The U.S. Food and Drug Administration (FDA) granted the vaccine an “emergency use authorization” for adolescents during the global MPOX outbreak in 2022.

The virus has hit the Democratic Republic of Congo and has already killed 548 people this year.

Sweden and Pakistan reported the first cases of the virus outside Africa this week, and the WHO warns that more imported cases of the new variant are likely to enter Europe.

The infectious disease is caused by a virus that is transmitted from animals to humans. However, transmission from person to person is also possible through close physical contact.

It causes fever, muscle aches and large, boil-like skin lesions.

Bavarian Nordic said on Thursday that the company was ready to produce ten million vaccine doses by 2025, but was waiting for orders from individual countries.

The company said it had around 500,000 doses in stock.

© 2024 AFP