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LONDON – Danish biotech company Bavarian Nordic said on Friday that it had submitted data to the European Union's medicines regulator to expand the use of its Mpox vaccine in adolescents.
CEO Paul Chaplin told CNBC that the expanded eligibility for 12- to 17-year-olds is critical to contain the outbreak of the latest virus variant group 1b, which particularly affects teenagers and young children.
Earlier on Wednesday, the World Health Organization declared an escalating MPOX outbreak in Africa a public health emergency after the first case of the new variant outside the continent was confirmed in Sweden on Thursday.
“The latest data we have presented is really, really important because it will hopefully help expand the use of our vaccine in adolescents as well,” Chaplin told Squawk Box Europe.
“More than 70 percent of cases in Africa currently affect people under 18, so it is crucial that our vaccine can also 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 ages 18 and older. It is also the only mpox vaccine approved by the U.S. Food and Drug Administration and the European Medicines Agency.
If the EMA approves the vaccine for teenagers, the company says this would pave the way for approval for teenagers in Africa. The company is also currently studying the effectiveness of the vaccine in children aged 2 and over. The results are expected next year.
Following the WHO's declaration of a state of emergency, Bavarian Nordic's share price rose 17 percent on Thursday, as did other stocks in the healthcare sector, as demand for the vaccine was expected to increase. By midday on Friday, the share price in Copenhagen was up another 17.5 percent.
Chaplin said the company has significant stockpiles of the vaccine and it is “ready to ship” to countries in need, but he pointed to shortages in Africa that have so far prevented distribution.
The vaccine is currently only approved in the Democratic Republic of Congo – the epicenter of the outbreak – and Nigeria. Chaplin said the company continues to work with authorities in affected neighboring countries to enable access to the vaccine.
“There is now an approval in the Democratic Republic of Congo and also in Nigeria. That now opens the door, both for governments to buy the vaccine and for Bavarian Nordic, as we have done, to donate doses and have those doses shipped and hopefully we can start vaccinating people very, very soon,” he said.
According to the WHO, more than 15,000 cases and at least 537 deaths have been reported so far this year in connection with the outbreak in the Democratic Republic of Congo. The outbreak followed an earlier outbreak of a different Mpox strain 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 for travellers to affected countries, but the WHO said it was not recommending border closures at this time.
Chaplin said authorities were now better able to tackle the outbreak because vaccine doses were already available, particularly in wealthy countries that had built up large stockpiles during the last outbreak. But he urged greater international cooperation to ensure vaccine doses reached those who needed them most.
“Bavarian Nordic is part of the solution, but we are not the only solution,” he said. “The international community needs to work with Bavarian Nordic and really find a way to distribute this vaccine and contain the outbreak.”
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