Bavarian Nordic and CEPI to Boost Mpox Vaccination in Africa

COPENHAGEN, Denmark / OSLO, Norway, May 30, 2024 – Bavarian Nordic, in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), has announced a significant initiative aimed at advancing the development of its mpox vaccine, MVA-BN®, for children in Africa. This comes as CEPI has awarded $6.5 million to support a Phase 2 clinical trial set to commence later in 2024.

The trial is designed to evaluate the immunogenicity and safety of the MVA-BN® vaccine in children aged 2 to under 12 years, in comparison to adults aged 18-50 years. The study will be conducted in regions endemic to mpox, enrolling approximately 460 healthy participants who have no history of mpox infection or poxvirus vaccination. Participants will receive two doses of the vaccine. The trial will be led by Bavarian Nordic and conducted across one or more African nations.

This new trial aligns with recent initiatives by Africa CDC and African Ministries of Health to bolster mpox preparedness and response. It also supports the World Health Organization's (WHO) framework for mpox prevention and control. The trial's outcomes could extend current regulatory approvals for the vaccine, which is currently approved for adults, to include children aged 2-12 years. Additionally, the study aims to generate critical data on the vaccine's efficacy in African populations, potentially facilitating regulatory approval in endemic countries.

Dr. Richard Hatchett, CEO of CEPI, highlighted the urgent need to protect children, who are disproportionately affected by mpox. He emphasized the importance of this trial in providing essential safety and immunogenicity data, which will be key to shaping future vaccine strategies to safeguard children and curb the outbreak in DR Congo and other endemic regions.

Paul Chaplin, President, and CEO of Bavarian Nordic, expressed the company's commitment to equitable vaccine access and collaboration with local authorities to protect vulnerable populations. He underscored the pressing need for a reliable mpox vaccine given the high incidence and impact of the disease on children in the DR Congo.

Mpox in Africa

Central and East Africa are currently experiencing the largest and deadliest mpox outbreak recorded. In the DR Congo alone, over 6,500 cases and 345 deaths have been reported this year, with children being the most affected. The outbreak also extends to the Congo, Cameroon, Central African Republic, and Liberia. Mpox, first identified in the DR Congo in 1970, typically presents symptoms such as fever and painful lesions, which usually resolve within weeks. However, severe cases can lead to complications like bronchopneumonia, sepsis, encephalitis, vision loss, and even death. The current outbreak strain, Clade I, has a fatality rate of around 8-12%.

About MVA-BN Vaccine

The MVA-BN vaccine, also known as Modified Vaccinia Ankara-Bavarian Nordic, is a non-replicating smallpox vaccine approved for use in the U.S., Switzerland, Canada, the EU/EEA, and the UK under various brand names like JYNNEOS®, IMVAMUNE®, and IMVANEX®. Initially developed with the U.S. government to cater to immunocompromised individuals, the vaccine is approved for adults at risk of smallpox or mpox. During the 2022-2023 mpox outbreak, it received Emergency Use Authorization from the U.S. FDA for use in adolescents.

Bavarian Nordic has been a key supplier of the vaccine to numerous countries, enhancing their biological preparedness. During the mpox outbreak of 2022-2023, the company expanded vaccine access to over 70 countries globally.

About CEPI

CEPI, launched in 2017, is a partnership involving public, private, philanthropic, and civil organizations. Its mission is to accelerate the development of vaccines against epidemic and pandemic threats to ensure global accessibility. CEPI has supported the development of over 50 vaccine candidates against high-risk pathogens and aims to develop vaccines against new threats within 100 days as part of its '100 Days Mission'.

About Bavarian Nordic

Bavarian Nordic is a leading vaccine company focused on protecting lives through innovative vaccines. The company is a global leader in smallpox and mpox vaccines and has a robust portfolio catering to travelers and endemic diseases.

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