SWEDEN —Danish biotech company Bavarian Nordic has submitted data to the European Union’s drug regulator, seeking approval to extend the use of its Mpox and smallpox vaccine, Jynneos (also known as Imvanex), to adolescents aged 12 to 17.
This move comes as the World Health Organization has declared Mpox a global public health emergency, highlighting that children and adolescents are particularly vulnerable to the disease.
The urgency for expanding the vaccine’s use is further underscored by the recent emergence of a new Mpox virus strain in Sweden, which has been linked to a growing outbreak in Africa.
This development signals the virus’s spread beyond the continent, raising concerns about its potential global impact.
Bavarian Nordic has indicated that, following the European Medicines Agency’s review, the vaccine’s marketing authorization could be extended to include adolescents during the fourth quarter of this year.
The company is also preparing to launch a clinical trial to assess the vaccine’s safety in children aged 2 to 12, which could pave the way for further age group expansions.
This trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is scheduled to begin later this year in the Democratic Republic of Congo and Uganda.
The company’s CEO, Paul Chaplin, emphasised the importance of the expanded approval for 12- to 17-year-olds, particularly in light of the latest strain of the virus, clade 1b, which predominantly affects teenagers and young children.
“More than 70% of the cases in Africa currently are in people younger than 18, so it’s going to be critical that our vaccine can be used in this younger age group,” Chaplin stated in an interview with CNBC.This highlights the growing need for effective preventative measures in the region.
Bavarian Nordic’s Jynneos vaccine is currently approved for use only in adults aged 18 and over. It remains the only Mpox vaccine approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
However, it is also the only vaccine approved in the Democratic Republic of Congo, which is considered the epicentre of the current outbreak, and in Nigeria.
Chaplin said that the company is collaborating closely with authorities in surrounding impacted countries to ease access to the vaccine, allowing them to procure and vaccinate their populations.
Bavarian Nordic has also taken steps to contribute to and expedite the shipment of 40,000 doses of its Mpox vaccine to the Africa CDC, with the hope that Africa can begin vaccinating individuals, particularly the most vulnerable.
Since the outbreak began in January 2023, the Democratic Republic of Congo has reported over 27,000 cases and more than 1,100 deaths, predominantly among children.
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