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Danish biotech company Bavarian Nordic announced Friday that it has submitted data to the European Union’s drug regulator, seeking approval to expand the use of its mpox (formerly monkeypox) vaccine to adolescents aged 12 to 17.
This move is seen as critical as the ongoing outbreak in Africa has disproportionately affected children and teenagers, underscoring the urgency of expanding vaccine access to this vulnerable population, according to Bavarian CEO Paul Chaplin.
The European Medicines Agency (EMA) is currently reviewing the application, with Bavarian Nordic indicating that approval could come as early as the fourth quarter of this year. The company also plans to initiate a clinical trial to assess the vaccine's safety in younger children aged 2 to 12, potentially broadening its use even further.
The World Health Organization (WHO) has declared the growing spread of mpox in Africa a global health emergency, signaling that the virus could potentially spread worldwide if conditions allow. This declaration followed an emergency meeting led by WHO Director-General Dr. Tedros Adhanom Ghebreyesus and the United Nations' health crisis committee. The African Centre for Disease Control and Prevention (CDC) has similarly classified the outbreak as an urgent public health emergency for the continent.
As of this year, Africa has reported 14,000 mpox cases and 524 deaths, a significant increase compared to last year, with over 96% of cases concentrated in the Democratic Republic of the Congo (DRC). Scientists are particularly concerned about a new variant, known as clade Ib, which appears to spread more easily among humans than the previously dominant clade I strain.
In response to the escalating situation, China has implemented enhanced surveillance measures for six months, targeting the movement of people and goods from regions with confirmed mpox cases. Chinese customs officials have announced that travelers from affected countries must declare any contact with symptomatic individuals or their own symptoms, while vehicles, containers, and goods from these regions will undergo disinfection procedures.
On Friday, the European Centre for Disease Prevention and Control (ECDC) raised its alert level for mpox from "low" to "moderate," urging heightened awareness, particularly among travelers from affected areas. The ECDC noted that the risk of transmission in Europe remains low due to the rapid diagnosis of imported cases and the implementation of control measures. However, the current outbreak in the DRC, driven by the clade I strain, has raised concerns about its potential to spread to Europe.
ECDC Director Pamela Rendi-Wagner emphasized the need for European health authorities to prepare for possible imported cases of clade I, given the close ties between Europe and Africa. She added that while the overall impact of the virus in Europe is expected to be minimal with proper surveillance and control measures, authorities should remain vigilant.
EU Health Commissioner Stella Kyriakides told "Kathimerini" that the European Commission has been closely monitoring the mpox outbreak in Africa and has convened the Health Security Committee, which includes representatives from all EU member states, to discuss necessary measures. Kyriakides expressed concern that more cases are likely in the coming days, particularly given the extensive travel links between Europe and Africa.
Following the first confirmed case of the clade Ib strain in Sweden on Thursday, Kyriakides contacted the Swedish Health Minister to coordinate responses. She stressed the importance of member states taking appropriate actions, including being prepared to identify and manage suspected cases swiftly.
Regarding vaccines, Kyriakides noted that the European Commission is working to secure vaccine doses for affected countries. She reassured that all EU member states currently have access to vaccines, and additional doses can be procured if needed.
