Bavarian Nordic is expanding its focus on mpox prevention by initiating a Phase II clinical trial to evaluate its MVA-BN vaccine in children aged 2 to 11. The trial aims to broaden the vaccine's approval label to include this younger population, addressing a critical gap in mpox prevention strategies. The study is crucial as it marks the first investigation of MVA-BN as an mpox/smallpox vaccine for younger children.
The Phase II study (NCT06549530) is designed to compare the safety and immunogenicity of the MVA-BN vaccine in children aged 2-11 years with that of adults. This comparative approach will provide essential data for regulatory submissions and label expansion. The trial is receiving partial funding from the Coalition for Epidemic Preparedness Innovations (CEPI), highlighting the global importance of this research.
Trial Locations and Objectives
Bavarian Nordic plans to recruit participants from the Democratic Republic of Congo and potentially Uganda, regions where mpox outbreaks have been a significant concern. The World Health Organization (WHO) has declared mpox a global public health emergency, underscoring the urgent need for effective preventive measures, especially in vulnerable populations.
Dr. Nicole Lurie, executive director of preparedness and response at CEPI, stated, “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.”
MVA-BN Vaccine Background
MVA-BN is a non-replicating mpox vaccine marketed as Jynneos in the US and Imvanex in Europe. It has already received approval for use in adults and adolescents. In September, the European Medicines Agency (EMA) expanded the vaccine label to include adolescents over 12 years of age. Additionally, the Global Alliance for Vaccines and Immunization (GAVI) has entered into a purchase agreement with Bavarian Nordic to secure 500,000 doses for countries in Africa.
Financial Impact and Other Mpox Vaccine Development
The mpox vaccine has been a significant revenue generator for Bavarian Nordic, contributing DKK5bn ($724m) in revenue from global vaccine sales and government contracts last year. Other companies are also developing mpox vaccines, including Moderna, which is conducting a Phase I/II study (NCT05995275) to evaluate the safety, tolerability, and immunogenicity of its mRNA vaccine, mRNA-1769, in healthy adults.
