Bavarian Nordic is considering extending the approval label for its MVA-BN mpox/smallpox vaccine to children aged 2 to 11 years and has initiated a Phase 2 trial to support approval.
The Phase II study (NCT06549530) is planned to compare the safety and immunogenicity of the vaccine between children and adults in that age group. The trial is partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
The Danish vaccine company plans to recruit participants across the Democratic Republic of Congo and potentially Uganda. The World Health Organization (WHO) declared mpox a global public health emergency for the second time in two years in August after the new virus spread from the Democratic Republic of the Congo to neighboring countries.
MVA-BN is a non-replicating MPOX vaccine. It is sold as Jynneos in the US and Imvanex in Europe. In September, the European Medicines Agency (EMA) expanded vaccine labeling to include adolescents aged 12 and older. That same month, the Global Alliance for Vaccines and Immunization (GAVI) signed a purchase agreement with the northern European state of Bavaria to secure 500,000 doses of vaccines for African countries.
The Bavarian Nordic newspaper reports that the phase 2 clinical trial will be the first study of MVA-BN as a Mpox/smallpox vaccine for young children, while a recombinant version of the vaccine, Mvavea, will be launched in 2020 as part of Prime Boost. He pointed out that it was approved by the EMA. A vaccine regimen to prevent the disease caused by the Ebola virus in individuals 1 year of age and older.
“The results of this study are critical to developing an mpox vaccine strategy that can protect children and end this devastating and widespread epidemic, as well as prevent possible future mpox epidemics.” This will provide vital vaccine guidance to residents in rural endemic areas as they respond,” said Dr. Nicole Lurie, CEPI’s Executive Director of Preparedness and Response.
The mpox/smallpox vaccine is a major revenue driver for the Nordic state of Bavaria. The vaccine generated revenue of 5 billion Danish kroner ($724 million) from global vaccine sales and government contracts last year, according to the company’s financial report.
Another mpox vaccine in development is Moderna’s mRNA vaccine, currently in Phase I/II trials (NCT05995275). This study evaluates the safety, tolerability, and immunogenicity of mRNA-1769 in healthy adults.
“Bavaria extends Mpox vaccine label to infants, begins Phase II trial” was originally created and published by Pharmaceutical Technology, a brand owned by GlobalData.
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