Mpox vaccine maker Bavarian Nordic seeks ‘critical’ EU approval for teens after WHO declares health emergency

LONDON — Danish biotech company Bavarian Nordic said Friday that it had submitted data to the Europe Union's drug regulator to extend the use of its mpox vaccine for teenagers.

CEO Paul Chaplin told CNBC that the expanded approval for 12 to 17 year-olds would be crucial in tackling the outbreak of the latest strain of the virus, clade 1b, which particularly afflicts teenagers and young children.

It comes after the World Health Organization on Wednesday declared an escalating mpox outbreak in Africa as a public health emergency, with the first case of the new strain outside of the continent confirmed in Sweden on Thursday.

"The latest data that we've submitted is really, really important because hopefully it will extend the use of our vaccine down to adolescents," Chaplin told "Squawk Box Europe."

"More than 70% of the cases in Africa currently are in people younger than 18, so it's going to be critical that our vaccine can be used in this younger age group," he said.

Bavarian Nordic's JYNNEOS vaccine, also known as IMVANEX, is currently only approved for use in adults aged 18 and over. It is also the only mpox vaccine approved by the Food and Drug Administration and the European Medicines Agency.

Should the EMA approve the vaccine for use for teenagers, the company said it would pave the way for approval among teens in Africa. The firm is also currently studying the vaccine's efficacy in children aged two and over, with results due next year.

The WHO's emergency declaration saw Bavarian Nordic's share price rally 17% on Thursday, alongside other healthcare stocks, amid perceptions of heightened demand for the vaccine. It was up a further 17.5% by midday Friday in Copenhagen, Denmark.

Chaplin said the company had significant