Bavarian Nordic expands MVA-BN Vaccine to young children

DENMARK—Bavarian Nordic has taken steps to widen the reach of its MVA-BN mpox/smallpox vaccine by launching a Phase II trial to include children aged two to 11 within its approval label.

 This study (NCT06549530) will compare the vaccine’s safety and immune response in young children with that in adults, aiming to extend protection to this vulnerable age group.

Partly funded by the Coalition for Epidemic Preparedness Innovations (CEPI), the trial will recruit participants from the Democratic Republic of Congo and potentially Uganda.

The decision to pursue this expanded approval follows a recent declaration by the World Health Organization (WHO), which classified mpox as a global public health emergency after a new variant spread from the Democratic Republic of Congo to neighboring countries.

This marks the second consecutive year the WHO has made such a declaration, highlighting the urgency of protecting younger populations, especially as the virus continues to impact Africa.

Bavarian Nordic’s MVA-BN vaccine, a non-replicating mpox vaccine, is marketed under the name Jynneos in the United States and Imvanex in Europe.

In September, the European Medicines Agency (EMA) broadened the vaccine’s approved use to cover adolescents over 12 years old.

During the same month, the Global Alliance for Vaccines and Immunization (GAVI) secured a contract with Bavarian Nordic to purchase 500,000 doses to support African countries, reflecting growing international efforts to address the ongoing outbreak.

In discussing the trial, Bavarian Nordic’s President and CEO, Paul Chaplin, emphasized that children are especially vulnerable to mpox infections as cases rise in Africa, highlighting the importance of expanding access to safe and effective vaccines for younger age groups.

He noted that the recent EMA approval for adolescents encouraged the company to pursue this Phase II study, as it could generate essential data to expand further the vaccine’s indication to include children as young as two.

Chaplin also extended gratitude to CEPI and African partners for their collaboration and support in making this trial possible.

This trial represents the first time Bavarian Nordic’s MVA-BN is being evaluated for mpox and smallpox protection specifically in young children.

However, it is not the vaccine’s first use in younger populations; in 2020, a recombinant version of MVA-BN, known as Mvabea, received EMA approval as part of a prime-boost regimen to prevent Ebola in individuals as young as one-year-old.

Studies supporting Mvabea’s approval included more than 3,300 participants across Europe, the United States, and Africa, with a cohort of over 800 children and adolescents in Africa aged one to 17. The safety profile in this younger group mirrored that observed in adults.

For her part, Dr. Nicole Lurie, CEPI’s Executive Director of Preparedness and Response, emphasized that data from this trial will be vital in forming mpox vaccine strategies that can protect children and help end the ongoing outbreak.

The findings could also provide essential guidance for future vaccine efforts to manage mpox outbreaks in endemic regions.

Bavarian Nordic’s mpox vaccine has been a significant revenue contributor, bringing in approximately DKK5bn (US$724 million) in global sales and government contracts last year.

Meanwhile, Moderna has also entered the mpox vaccine space with its mRNA-based candidate, mRNA-1769, which is currently in a Phase I/II trial (NCT05995275) to assess safety, tolerability, and immune response in healthy adults.