Danish drugmaker Bavarian Nordic said it is seeking EU approval to use its monkeypox vaccine on children aged between 12 and 17. This happened after the WHO declared the current virus wave a global public health emergency, reported AFP.
The World Health Organization (WHO) this week declared the rapid spread of a new, more dangerous strain of monkeypox, called Clade 1b, a public health emergency of international concern – the highest level of alert the UN agency can announce.
The Bavarian Nordic vaccine is currently only approved for people 18 and older.
"Children and adolescents are disproportionately affected by monkeypox in the ongoing epidemic in Africa, highlighting the importance and urgency of expanding access to vaccines and therapies for vulnerable populations," said Bavarian Nordic CEO Paul Chaplin.
The company said it submitted clinical data from a study to the European Medicines Agency that showed "no superiority of immune response to monkeypox vaccination in adolescents and a similar safety profile compared to adults."
The US Food and Drug Administration (FDA) granted the vaccine "emergency use authorization" for adolescents during the 2022 global measles outbreak.
The virus has swept through the Democratic Republic of Congo, killing 548 people this year.
This week, Sweden and Pakistan reported their first cases of the virus outside Africa, and the WHO has warned that new cases of the new strain are likely to be imported into Europe.
Monkeypox is an infectious disease caused by a virus that is transmitted to humans from infected animals, but can also be transmitted from person to person through close physical contact.
It causes fever, muscle aches and large boils on the skin.
On August 15, Bavarian Nordic announced that it was ready to supply 10 million doses of its vaccine by 2025, but was waiting for countries to place orders.
The Danish laboratory claims to have around 500,000 doses in stock. |BGNES
