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 approved label to include this younger population, addressing a critical need for pediatric mpox protection.
The Phase II study, identified as NCT06549530, will primarily assess the safety and immunogenicity of the MVA-BN vaccine in children compared to adults. The Coalition for Epidemic Preparedness Innovations (CEPI) is providing partial funding for the trial, highlighting the global importance of this research. The trial plans to enroll participants in the Democratic Republic of Congo and potentially Uganda, regions where mpox outbreaks have been a significant concern.
MVA-BN, a non-replicating mpox vaccine, is currently marketed as Jynneos in the United States and Imvanex in Europe. In September, the European Medicines Agency (EMA) extended the vaccine's label to include adolescents over 12 years old. Additionally, the Global Alliance for Vaccines and Immunization (GAVI) recently secured 500,000 doses of the vaccine from Bavarian Nordic for distribution in African countries.
"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," said Dr. Nicole Lurie, executive director of preparedness and response at CEPI.
MVA-BN and the Fight Against Mpox
MVA-BN has become a significant revenue source for Bavarian Nordic, generating DKK5bn ($724m) in revenue last year through global vaccine sales and government contracts. This trial marks the first evaluation of MVA-BN as an mpox/smallpox vaccine specifically for young children. However, a recombinant version of the vaccine, Mvabea, was approved by the EMA in 2020 as part of a prime-boost vaccine regimen for preventing Ebola virus disease in individuals one year and older.
Other Mpox Vaccine Developments
Moderna is also developing an mRNA vaccine against mpox, mRNA-1769, which is currently in a Phase I/II trial (NCT05995275). This trial is evaluating the safety, tolerability, and immunogenicity of the vaccine in healthy adults.
