Bavarian Nordic Begins Clinical Trial for Mpox Vaccine in Children 2-11 Years Old
COPENHAGEN, Denmark, October 29, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today the start of a clinical study to evaluate its MVA-BN® mpox/smallpox vaccine in children aged 2 to 11 years old. This important step follows recent approvals by the European Medicines Agency (EMA) and the World Health Organization (WHO) for adolescents aged 12 to 17.
Expanding Vaccine Access to Protect Vulnerable Children
The first participants have been vaccinated at sites in the Democratic Republic of Congo (DRC), with plans to include sites in Uganda. The study, funded in part by the Coalition for Epidemic Preparedness Innovations (CEPI), aims to enroll a total of 460 participants and will compare the safety and effectiveness of the vaccine in children aged 2 to 11 years old to adults.
"Children remain highly vulnerable to mpox infections in the ongoing outbreak in Africa," said Paul Chaplin, President & CEO of Bavarian Nordic. "Broadening access to effective vaccines that can be safely administered to this young population is crucial. Following the recent approval of MVA-BN for adolescents, we are pleased to initiate this study, which could provide valuable data to further extend the indication to include children."
Building on Existing Research and Safety Data
While this study marks the first investigation of MVA-BN in younger children, a recombinant version of the vaccine (Mvabea®) has already been approved by the EMA for use as part of a prime-boost vaccine regimen against Ebola virus in individuals 1 year of age and older.
Clinical trials supporting this approval included over 3,300 participants across Europe, the USA, and Africa, with over 800 children and adolescents aged 1 to 17 in Africa. The safety profile of Mvabea in children aged 1 to 17 was generally similar to that observed in adults.
About the MVA-BN mpox Vaccine
MVA-BN, marketed as JYNNEOS® in the U.S., IMVAMUNE® in Canada, and IMVANEX® in the EU/EEA and United Kingdom, is the only non-replicating mpox vaccine currently approved in several countries.
Originally developed as a smallpox vaccine, MVA-BN has been shown to be effective against both mpox and smallpox. It is particularly important for immunocompromised individuals who cannot safely receive traditional replicating smallpox vaccines.
Learn More
For more information about Bavarian Nordic and its commitment to fighting mpox, visit www.bavarian-nordic.com.