Bavarian Nordic A/S has commenced 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 currently enrolling participants in the Democratic Republic of Congo (DRC), with plans to expand to sites in Uganda. This trial aims to assess the safety and immunogenicity of the vaccine in this younger age group, potentially leading to an extension of its approved use.
The study, identified as NCT06549530, anticipates enrolling a total of 460 individuals. It will compare the vaccine's performance in children aged 2 to 11 years with that in adults. Partial funding for the study is provided by the Coalition for Epidemic Preparedness Innovations (CEPI). Positive results could support the expansion of MVA-BN's current approval to include children aged 2 and older.
This development follows the World Health Organization's (WHO) prequalification of the vaccine for adolescents aged 12 to 17, aligning with the European Medicines Agency's (EMA) recent approval for this age group. While this trial marks the first investigation of MVA-BN as an mpox/smallpox vaccine for younger children, a recombinant version of MVA-BN, known as Mvabea, received EMA approval in 2020 as part of a prime-boost vaccine regimen for preventing Ebola virus disease in individuals aged 1 year and older.
Clinical studies supporting the Mvabea approval involved over 3,300 individuals across Europe, the USA, and Africa, including more than 800 children and adolescents aged 1 to 17 in Africa. The safety profile of Mvabea in children aged 1 to 17 years was generally consistent with that observed in adults.
