EU Approves Use of Bavarian Nordic's Mpox Vaccine for Adolescents

Bavarian Nordic's mpox vaccine has gained approval for use in adolescents by the EU's drug regulator. This move is seen as essential for containing an outbreak in parts of Africa, with the World Health Organization declaring mpox a global public health emergency. The vaccine has also seen U.S. authorization for emergency adolescent use.

The EU's drug regulator has approved Bavarian Nordic's mpox vaccine for use in adolescents, a critical development in addressing outbreaks in parts of Africa. The World Health Organization (WHO) has flagged mpox as a global public health emergency, particularly affecting children and teenagers.

In the U.S., the Food and Drug Administration (FDA) had already approved Bavarian's JYNNEOS vaccine for adults 18 and older, with an Emergency Use Authorization in place for adolescents during the 2022 outbreak. The recent EU approval by the Committee for Medicinal Products for Human Use (CHMP) was based on data submitted by Bavarian Nordic to the European Medicines Agency (EMA).

Bavarian Nordic's CEO Paul Chaplin commended EMA for its swift review and approval. Meanwhile, the WHO allows off-label use of the vaccine for those under 18, although its formal recommendation is limited to adults. Despite the EMA decision, which guides European countries, the Democratic Republic of Congo will not vaccinate under-18s in its initial immunization wave, highlighting different global strategies in response to the outbreak.

(With inputs from agencies.)