Bavarian Nordic A/S has announced the start of a clinical trial to evaluate its MVA-BN® mpox/smallpox vaccine in children aged 2 to 11 years. The first vaccinations have been administered as part of the study, which is actively enrolling participants in the Democratic Republic of Congo (DRC) and is planned to expand to sites in Uganda. This trial follows recent approvals from the EMA and WHO for the use of the MVA-BN vaccine in adolescents aged 12-17.
Study Design and Objectives
The clinical study, identified as NCT06549530, aims to enroll 460 individuals to compare the safety and immunogenicity of the MVA-BN vaccine in children aged 2 to 11 years with that in adults. The Coalition for Epidemic Preparedness Innovations (CEPI) is providing partial funding for the study. The primary goal is to gather data that could support the extension of the current approval of MVA-BN to include children aged 2 years and older.
Addressing a Critical Need
Paul Chaplin, President & CEO of Bavarian Nordic, emphasized the urgency of the study, stating, "Children remain highly vulnerable to mpox infections in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to effective vaccines that can be safely administered to this young population." Dr. Nicole Lurie, Executive Director of Preparedness and Response at CEPI, added that the study's findings will be crucial in shaping mpox vaccine strategies to protect children and tackle future outbreaks.
MVA-BN: A Non-Replicating Vaccine
MVA-BN, also known as Modified Vaccinia Ankara-Bavarian Nordic, is the only non-replicating mpox vaccine approved in the U.S., Switzerland, Singapore, Mexico, Canada, the EU/EEA, and the United Kingdom. It was initially developed as a smallpox vaccine in collaboration with the U.S. government. It is approved for use in individuals considered at risk for smallpox or mpox infection. A recombinant version of MVA-BN (Mvabea®) was previously approved by the EMA in 2020 as part of an Ebola virus vaccine regimen for individuals 1 year and older, with clinical studies involving over 800 children and adolescents in Africa demonstrating a safety profile generally similar to that observed in adults.
