Bavarian Nordic is expanding the evaluation of its MVA-BN mpox/smallpox vaccine, initiating a Phase II trial to include children aged 2 to 11 years. This move aims to broaden the vaccine's approved label and address the need for pediatric protection against mpox.
The Phase II study (NCT06549530) is designed to compare the safety and immunogenicity of MVA-BN in children aged 2-11 years with that in adults. The trial is receiving partial funding from the Coalition for Epidemic Preparedness Innovations (CEPI).
Trial Locations and Objectives
Bavarian Nordic intends to recruit participants from the Democratic Republic of Congo and potentially Uganda. This is particularly relevant as the World Health Organization (WHO) declared mpox a global public health emergency in August, following a new viral strain spreading from the Democratic Republic of Congo to neighboring countries.
MVA-BN Vaccine Details
MVA-BN is a non-replicating mpox vaccine, marketed as Jynneos in the US and Imvanex in Europe. In September, the European Medicines Agency (EMA) extended the vaccine's label to include adolescents over 12 years of age. Additionally, the Global Alliance for Vaccines and Immunization (GAVI) entered into a purchase agreement with Bavarian Nordic to secure 500,000 doses for distribution in African countries.
Prior Approvals and Future Implications
Bavarian Nordic highlighted that while this Phase II trial is the first investigation of MVA-BN as an mpox/smallpox vaccine for younger children, a recombinant version, Mvabea, was approved by the EMA in 2020. Mvabea is part of a prime-boost vaccine regimen for preventing Ebola virus disease in individuals one year and older.
Expert Commentary
Dr. Nicole Lurie, executive director of preparedness and response at CEPI, stated, "The findings of this study will be crucial in shaping mpox vaccine strategies that could protect children and bring an end to this devastating and widespread outbreak, while also providing pivotal vaccine guidance in local endemic populations to tackle mpox outbreaks that could strike in the future."
Financial Impact
The mpox/smallpox vaccine has been a significant revenue source for Bavarian Nordic, generating DKK5 billion ($724 million) in revenue from global sales and government contracts last year.
Other Mpox Vaccine Developments
Moderna is also developing an mRNA mpox vaccine, mRNA-1769, currently in a Phase I/II study (NCT05995275) to evaluate its safety, tolerability, and immunogenicity in healthy adults.
