Bavarian seeks Mpox vaccine label expansion to toddlers, starts Phase II trial

Bavarian Nordic is looking to broaden the approval label of its MVA-BN vaccine for the prevention of mpox and smallpox to include children aged two to 11. To support this goal, the company has initiated a Phase II clinical trial. This study, registered under NCT06549530, aims to assess the safety and immune response generated by the vaccine in young children compared to adults. This trial receives partial funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

The Danish company plans to enlist participants from the Democratic Republic of Congo and possibly Uganda. This comes after the World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years, following the emergence of a new virus strain that spread from the Democratic Republic of Congo to neighboring countries.

MVA-BN, a non-replicating mpox vaccine, is marketed as Jynneos in the United States and as Imvanex in Europe. In September, the European Medicines Agency (EMA) expanded the vaccine's approved use to include adolescents over 12 years of age. Simultaneously, the Global Alliance for Vaccines and Immunization (GAVI) secured 500,000 doses of the vaccine for African countries through a purchase agreement with Bavarian Nordic.

While the Phase II trial is the first to explore MVA-BN as an mpox and smallpox vaccine for younger children, a recombinant version of this vaccine, known as Mvabea, received approval from the EMA in 2020. Mvabea is part of a prime-boost vaccine regimen designed to prevent diseases caused by the Ebola virus in individuals aged one year and older.

Dr. Nicole Lurie, executive director of preparedness and response at CEPI, emphasized the importance of the study's findings. She noted that the study will be essential in developing mpox vaccine strategies to protect children and control outbreaks. These findings will also guide future vaccination efforts in areas where mpox is endemic.

The mpox and smallpox vaccine has been a significant revenue generator for Bavarian Nordic. The company reported that the vaccine generated DKK5 billion (approximately $724 million) in revenue from global vaccine sales and government contracts last year.

Additionally, another mpox vaccine is under development by Moderna. This mRNA-based vaccine, identified as mRNA-1769, is currently undergoing Phase I/II clinical trials. The study aims to evaluate the safety, tolerability, and immune response of the vaccine in healthy adults.