Bavarian says mpox vaccine approved by EU regulator for adolescents

Published : 2 weeks ago, on 19/09/2024

LONDON (Reuters) -Bavarian Nordic said on Thursday its mpox vaccine was approved by the EU’s drug regulator for use in adolescents, bolstering the case for using the shot in the 12 to 17 age group to contain an outbreak in parts of Africa.

Mpox has been declared a global public health emergency by the World Health Organization (WHO), with children and adolescents being particularly vulnerable to the disease.

Bavarian’s JYNNEOS has also been approved by the U.S. Food and Drug Administration (FDA) but only for adults 18 years and older, although it granted an Emergency Use Authorization for its use in adolescents during the mpox outbreak of 2022.

Its approval by the Committee for Medicinal Products for Human Use (CHMP), draws on data submitted by the Danish biotech firm to the European Medicines Agency (EMA) last month.

“We applaud EMA for their expedited review and decision to recommend approval,” said Bavarian CEO Paul Chaplin.

While the WHO says the vaccine can be used “off-label” for people below 18, it has only backed its use in adults.

WHO approval can guide domestic choices, as well as allowing international aid groups to buy and distribute a vaccine.

Democratic Republic of Congo (DRC), worst-hit by the current outbreak, is not planning to vaccinate under-18 year olds in its first wave of immunisations with the Bavarian vaccine.

Another mpox vaccine, made by the Japan’s KM Biologics, can already be given to children, according to the Japanese regulator, although it requires a special kind of needle.

While the EMA decision does not officially guide countries outside Europe, Congo referred to its evaluation of Bavarian’s vaccine in its June emergency use approval of the shot domestically. It also mentioned the FDA approval.

Since this outbreak began in January, there have been nearly 25,100 cases and more than 720 deaths in Africa, where the country reporting the most cases is the DRC, the WHO says.

(Reporting by Maggie Fick, editing by Terje Solsvik and Alexander Smith)