In May 2024, CEPI and Bavarian Nordic announced a partnership to advance the development of Bavarian Nordic’s mpox vaccine in children in Africa. An estimated $6.5 million will be awarded to support a Phase II clinical study to evaluate the immunogenicity and safety of the MVA-BN ® non-replicating vaccine in children between the ages of 2 years and under 12 years compared to adults aged 18 to 50 for the prevention of smallpox, mpox, and related orthopoxvirus infections.
MVA-BN
MVA-BN (Modified Vaccinia Ankara –Bavarian Nordic) is Bavarian Nordic’s proprietary and patented vaccine platform. It is “robust and adaptable” with applications for a “wide variety” of infectious disease and cancers. One of the advantages offered by MVA-BN is that the virus is unable to replicate in a vaccinated individual, which “likely contributes to the favourable safety profile”. MVA-BN induces strong cellular activity (CTL) and humoral (antibody) response with a demonstrated ability to stimulate a response even in individuals who have pre-existing immunity against vaccinia.
The study
The organisations hope to enrol around 460 healthy individuals in endemic regions who have not previously been infected with mpox or had poxvirus vaccination. They will receive two doses of the MVA-BN vaccine. The trial will be conducted in one or more African countries and follows the recent publication of a continental plan by Africa CDC and African Ministries of Health to strengthen preparedness and response efforts.
If the study goes well, experts hope it could “provide assurance” of the use of the vaccine in children, supporting an extension of current regulatory approvals to include children. Furthermore, it will generate evidence from endemic African populations, which could support regulatory approval in endemic countries.
Protecting children
Dr Richard Hatchett, CEPI’s CEO, shared that “we now understand that children suffer disproportionately from mpox”, which is already a “concerning and neglected disease”.
“To address the risk that children face in DR Congo and other areas where the disease is endemic, CEPI is supporting this important trial which will provide key mpox vaccine safety and immunogenicity data in children.”
Dr Hatchett hopes that the study will shape vaccine strategies to “help protect children” bring an end to the “widespread outbreak in the DR Congo” and other future outbreaks. President and CEO of Bavarian Nordic, Paul Chaplin, is “very pleased to join forces with CEPI” in “continued efforts to provide equitable access to a much-needed vaccine”.
“We are firmly committed to working with the local authorities to develop solutions for vulnerable populations, including children who sadly represent the vast majority of those affected by the ongoing mpox outbreak in the DR Congo.”
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