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 European 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 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 U.S. Food and Drug Administration and the European Medicines Agency.

Should the EMA clear 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 2 and over, with results due next year.

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

Chaplin said that the company had significant stockpiles of the vaccine and that it was “ready to ship” to countries in need. However, he cited bottlenecks in Africa that have so far prevented its distribution.

The vaccine is currently only approved in the Democratic Republic of Congo — the epicenter of the outbreak — as well as Nigeria. Chaplin said the company was continuing to work with authorities in neighboring affected countries to enable access to the vaccine.

“There is now an approval in the DRC, also in Nigeria, so it opens the door now, both for governments to buy the vaccine, but also for Bavarian Nordic, as we have, to donate doses and get those doses shipped, and hopefully we can start vaccinating people very, very soon,” he said.

So far this year, more than 15,000 cases and at least 537 deaths have been reported from the outbreak, according to the WHO. It follows a previous outbreak of another mpox strain in 2022, which was also declared a public health emergency.

The European Centre for Disease Prevention and Prevention warned Friday of the high risk of infection for people traveling to affected countries, but the WHO said that it did not recommend border closures at this stage.

Chaplin said authorities were now in a better position to deal with the outbreak, with doses of the vaccine already available, particularly in wealthy countries, which created stockpiles during the last outbreak. But he urged greater international cooperation to ensure doses reach those most in need.

“Bavarian Nordic is part of the solution, but we are not the sole solution here,” he said. “The international community needs to come together with Bavarian Nordic and really find a way of distributing this vaccine and containing the outbreak.”