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Bavarian Nordic Seeks Expanded Approval for Mpox Vaccine Amid Rising Outbreak
LONDON — Bavarian Nordic, a Danish biotechnology firm, announced on Friday that it has submitted new data to the European Union’s drug regulator in an effort to expand the use of its mpox vaccine for adolescents aged 12 to 17. This development comes as the World Health Organization (WHO) recently classified a burgeoning mpox outbreak in Africa as a public health emergency.
CEO Paul Chaplin emphasized the importance of this potential approval during an interview with CNBC, noting that the new strain of mpox, clade 1b, particularly affects teenagers and young children. “The latest data that we’ve submitted is really critical because it could potentially make our vaccine available for adolescents,” Chaplin stated. He highlighted that over 70% of current cases in Africa are among individuals under 18, reinforcing the need for vaccination in this demographic.
Currently, Bavarian Nordic’s JYNNEOS vaccine, also known as IMVANEX, is approved only for adults aged 18 and older and holds the distinction of being the only mpox vaccine authorized by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
If the EMA grants approval for the teenage demographic, Bavarian Nordic anticipates that this could facilitate wider access to the vaccine in African nations, where the outbreak’s effects are particularly severe. The company is also investigating the vaccine’s efficacy in younger children, with results from those studies expected next year.
The WHO’s declaration regarding the outbreak significantly impacted market perceptions, leading to a 17% increase in Bavarian Nordic’s stock on Thursday, with shares climbing an additional 17.5% in midday trading on Friday. This surge reflects a growing anticipation of increased demand for vaccines in light of the health crisis.
Chaplin confirmed that Bavarian Nordic is well-prepared with substantial vaccine stockpiles, ready for distribution to countries in urgent need. However, he acknowledged existing logistical hurdles in Africa that have thus far hampered the vaccine’s delivery. Currently, the vaccine has received approval only in the Democratic Republic of Congo and Nigeria, areas severely affected by the outbreak.
He explained the critical nature of this approval: “Now that we have the green light in the DRC and Nigeria, it enables governments to procure the vaccine. This also allows Bavarian Nordic to donate doses and facilitate their shipment, enabling us to start vaccinating people as soon as possible.”
As of this year, the WHO has reported over 15,000 cases and at least 537 deaths related to the mpox outbreak, following a previous incident with another strain in 2022, which was also classified as a public health emergency.
Chaplin expressed confidence in the availability of vaccine doses, especially in wealthier nations. He urged for increased international collaboration to ensure that the vaccines reach vulnerable populations. “Bavarian Nordic is part of the solution, but we are not the sole solution here,” he reiterated. “The international community must unite with Bavarian Nordic to effectively distribute this vaccine and manage the outbreak.”
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