Bavarian Nordic is expanding its focus on mpox prevention by initiating a Phase II clinical trial (NCT06549530) to evaluate the safety and immunogenicity of its MVA-BN mpox/smallpox vaccine in children aged 2 to 11 years. This move aims to extend the vaccine's approval label to include this younger population, addressing a significant need in mpox prevention strategies.
Trial Design and Objectives
The Phase II study is designed to compare the immune response and safety profile of the MVA-BN vaccine in children with those observed in adults. The trial is being partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), highlighting the global importance of this research. The study plans to recruit participants from the Democratic Republic of Congo and potentially Uganda, regions that have experienced recent mpox outbreaks.
MVA-BN Vaccine: Background and Approvals
MVA-BN, marketed as Jynneos in the US and Imvanex in Europe, is a non-replicating vaccine. It has already received approval for use in adults and adolescents over 12 years of age. In September, the European Medicines Agency (EMA) expanded the vaccine label to include adolescents. Furthermore, the Global Alliance for Vaccines and Immunization (GAVI) has secured 500,000 doses of the vaccine from Bavarian Nordic for distribution in African countries.
Addressing Mpox in Vulnerable Populations
The World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years in August, following the spread of a new strain of the virus from the Democratic Republic of Congo to neighboring countries. This underscores the urgent need for effective prevention strategies, particularly in vulnerable populations such as children.
Expert Commentary
Dr. Nicole Lurie, executive director of preparedness and response at CEPI, emphasized the importance of the trial's findings: "The findings of this study will be crucial in shaping mpox vaccine strategies that could protect children and bring an end to this devastating and widespread outbreak, while also providing pivotal vaccine guidance in local endemic populations to tackle mpox outbreaks that could strike in the future."
Financial Impact and Market Context
The mpox/smallpox vaccine has been a significant revenue source for Bavarian Nordic, generating DKK5 billion ($724 million) in revenue from global sales and government contracts last year. Other companies are also developing mpox vaccines, including Moderna, whose mRNA vaccine is currently in Phase I/II trials (NCT05995275) to assess safety, tolerability, and immunogenicity in healthy adults.
