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London—Danish Biotech Bavaria Nordic The company said on Friday it had submitted data to the European Union’s drug regulator to expand the use of its MPOX vaccine in teenagers.
Chief Executive Paul Chaplin told CNBC that expanding approval to children ages 12 to 17 is critical to combating the outbreak of the latest strain of the virus, Type 1b, which has particularly troubled teenagers and young children.
Previously, the World Health Organization declared the escalating MPO outbreak 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.
Chaplin told “Squawk Box Europe”: “The latest data that we have submitted is very, very important because hopefully it will expand the use of our vaccine into adolescents.”
He said: “More than 70% of cases in Africa are currently in people under the age of 18, so it is critical that our vaccine can be used in this younger age group.”
Bavarian Nordic’s JYNNEOS vaccine, also known as IMVANEX, is currently only approved for use in adults 18 and older. It is also the only MPOX vaccine approved by the U.S. Food and Drug Administration and the European Medicines Agency.
The company said if the EMA approves the vaccine for adolescents, it would pave the way for approval for teenagers in Africa. The company is also currently studying the vaccine’s efficacy in children aged two and older, with results due next year.
The World Health Organization’s emergency declaration sent shares in Bavaria Nordic rising 17% on Thursday, along with other health care stocks, amid perceptions of increased demand for vaccines. Shares in Copenhagen, Denmark, were up a further 17.5% as of midday on Friday.
Chaplin said the company has a large stockpile of vaccines and is “ready to ship” to countries in need. However, he cited bottlenecks in Africa that have so far hampered its distribution.
The vaccine is currently only approved in the Democratic Republic of Congo and Nigeria, the epicenter of the outbreak. Chaplin said the company was continuing to work with authorities in affected neighboring countries to secure access to vaccines.
“Now that the Democratic Republic of the Congo and Nigeria have received approval, the door is now open for governments to purchase vaccines, and for Bavaria Nordic (like us) to donate vaccines and ship those vaccines, and hopefully we can start giving them to people very soon. Get vaccinated,” he said.
The outbreak has reported more than 15,000 cases and at least 537 deaths so far this year. To the World Health Organization. This follows an outbreak of another MPOX strain in 2022, which was also declared a public health emergency.
The European Center for Disease Prevention warned on Friday that people traveling to affected countries were at high risk of contracting the virus, but the World Health Organization said border closures were not recommended at this stage.
Chaplin said authorities are now better able to respond to the outbreak because vaccine doses are already available, especially in rich countries that built up stockpiles during the last outbreak. But he urged greater international cooperation to ensure doses are available to those who need them most.
“Bavaria Nordisk is part of the solution, but we are not the only solution,” he said. “The international community needs to unite with Bavaria Nordic to really find a way to distribute this vaccine and contain the outbreak.”
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