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LONDON — Danish biotechnology company Bavarian Nordic said on Friday it had submitted data to the European Union's drug regulator to expand the use of its MPOX vaccine for adolescents.
Chief Executive Officer Paul Chaplin told CNBC that expanded approval for 12- to 17-year-olds would be crucial to addressing the outbreak of the latest strain of the virus, clade 1b, which is particularly affecting teenagers and young children.
This comes after the World Health Organization declared a growing outbreak of mpox in Africa a public health emergency on Wednesday, and the first case of the new strain outside the continent was confirmed in Sweden on Thursday.
“The latest data we've presented is very, very important because we hope it will expand the use of our vaccine to adolescents,” Chaplin told Squawk Box Europe.
“Currently, more than 70% of cases in Africa are in people under 18 years of age, so it will 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 18 years of age and older. It is also the only mpox vaccine approved by the Food and Drug Administration and the European Medicines Agency.
If the EMA approves the vaccine for use in adolescents, the company said it would pave the way for approval among adolescents in Africa. The company is also currently studying the vaccine's efficacy in children aged two years and older, with results expected next year.
The WHO's emergency declaration sent Bavarian Nordic's share price up 17% on Thursday, along with other healthcare stocks, amid perceptions of increased demand for the vaccine. By midday on Friday, Bavarian Nordic's shares were up a further 17.5% in Copenhagen, Denmark.
Chaplin said the company had significant stocks of the vaccine and was “ready to ship” to countries that needed it. However, he cited bottlenecks in Africa that have so far impeded its distribution.
The vaccine is currently only approved in the Democratic Republic of Congo (the epicentre of the outbreak) and Nigeria. Chaplin said the company is still working with authorities in affected neighbouring countries to allow access to the vaccine.
“There is now an approval in the Democratic Republic of Congo and also in Nigeria, so the door is now open, both for governments to buy the vaccine, and for Bavarian Nordic, as we have done, to donate doses and send them, and hopefully we will be able to 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 an earlier outbreak of another strain of mpox in 2022, which was also declared a public health emergency.
The European Centre for Disease Prevention warned on Friday of a high risk of infection for people travelling to affected countries, but the WHO said it was not recommending border closures at this stage.
Chaplin said authorities were now better placed to deal with the outbreak as vaccine doses were already available, particularly in wealthy countries, which built up 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 only solution in this case,” she said. “The international community must join Bavarian Nordic and really find a way to distribute this vaccine and contain the outbreak.”
