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London – Danish biotech company Northern Bavarian German drugmaker MBOX said on Friday it had submitted data to the European Union's medicines regulator to expand the use of its MBOX vaccine to adolescents.
The company's CEO Paul Chaplin told CNBC that the expanded approval for children ages 12 to 17 would be crucial in addressing the outbreak of the latest strain of the virus, strain 1b, which is particularly affecting teens and young children.
This comes after the World Health Organization on Wednesday declared the escalating outbreak of the MBOX virus in Africa a public health emergency, with the first case of the new strain confirmed outside the continent in Sweden on Thursday.
“The latest data we have presented is really important because we hope it will help expand the use of our vaccine to include adolescents,” Chaplin told Squawk Box Europe.
“More than 70% of cases in Africa are currently in people under the age of 18, so it will be crucial that our vaccine is used in this younger age group,” he added.
Bavarian Nordic's Genus vaccine, also known as Imvanix, is currently approved for use only in adults 18 years of age and older. It is also the only mpox vaccine approved by the US Food and Drug Administration and the European Medicines Agency.
The company said that if the European Medicines Agency approves the vaccine for use in adolescents, this will pave the way for its approval among adolescents in Africa. The company is also currently studying the vaccine’s effectiveness in children aged two years and older, with results due next year.
Shares in Bavarian Nordic surged 17% on Thursday, along with other healthcare stocks, amid expectations of higher demand for the vaccine. They were up another 17.5% by midday Friday in Copenhagen, Denmark.
Chaplin said the company has large stockpiles of the vaccine and is “ready to ship” to countries in need. However, he pointed to bottlenecks in Africa that have so far prevented its distribution.
The vaccine has so far only been approved in the Democratic Republic of Congo — the epicenter of the outbreak — and Nigeria, and Chaplin said the company is continuing to work with authorities in neighboring affected countries to enable access.
“There is now approval in the Democratic Republic of the Congo, and also in Nigeria, so that opens the door now, both for governments to buy the vaccine, but also for Bavaria Nordic, as we have done, to donate doses and ship those doses, and hopefully we can start vaccinating people very soon,” he said.
So far this year, more than 15,000 cases and at least 537 deaths have been reported from the outbreak in the Democratic Republic of the Congo, according to the World Health Organization. This comes after another outbreak of dengue in 2022, which was also declared a public health emergency.
The European Centre for Disease Prevention and Control warned on Friday of a high risk of infection among people travelling to affected countries, but the World Health Organization said it was not recommending border closures at this stage.
Chaplin said authorities were now in a better position to deal with the outbreak, with vaccine doses already available, especially in rich countries that built up stockpiles during the recent 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 here. The international community must work together with Bavarian Nordic and find a real way to distribute this vaccine and contain the outbreak,” he said.
