Bavarian Nordic Updates on Mpox Vaccine Supply and Global Collaboration

COPENHAGEN, Denmark, August 17, 2024 – Bavarian Nordic A/S (OMX: BAVA) has announced its strategic plans to ensure the supply of vaccines to combat the ongoing mpox outbreak. The Africa Centers for Disease Control and Prevention (Africa CDC) declared the mpox outbreak a Public Health Emergency of Continental Security (PHECS) on August 13, 2024, followed by the World Health Organization (WHO) declaring it a Public Health Emergency of International Concern (PHEIC) on August 14, 2024.

Paul Chaplin, President & CEO of Bavarian Nordic, emphasized the company's commitment to working with all relevant parties to guarantee fair access to their mpox vaccine during the current health crises. They have established a robust partnership with Africa CDC, not only for supply but also for expanding their manufacturing network to include Africa. In cooperation with the WHO, Bavarian Nordic is working on a regulatory pathway to ensure global access to the vaccine. Additionally, they are seeking approval for use in adolescents and conducting clinical studies in Africa to potentially expand usage to children.

Bavarian Nordic has previously demonstrated its capability to meet global vaccine demands. During the mpox PHEIC in 2022/23, the company supplied over 15 million doses of the mpox vaccine to more than 76 countries through collaborations with various governments and organizations like HERA and PAHO. This extensive distribution played a significant role in controlling that outbreak, with the vaccine proving to be highly effective in reducing disease severity and hospitalizations after one or two doses.

To prepare for potential future outbreaks, Bavarian Nordic has established a vaccine inventory. In response to the current crisis, the company plans to increase vaccine production to maintain equitable access. They have informed the Africa CDC of their capacity to manufacture 10 million doses by the end of 2025, in addition to fulfilling existing orders, with the ability to supply up to 2 million doses within this year.

Given the persistent threat of mpox to public health, Bavarian Nordic is collaborating with the Africa CDC to further scale up manufacturing capacity in Africa by transferring technology to selected local manufacturers.

The company has also focused on the demographics most affected by the current outbreak. Notably, the majority of mpox cases in Africa involve individuals under 18 years old. Bavarian Nordic recently submitted clinical data to the European Medicines Agency (EMA) to support the use of their mpox vaccine in adolescents aged 12-17. This data was generated in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), a division of the U.S. National Institutes of Health (NIH), through a clinical study involving more than 300 participants within this age group.

Furthermore, Bavarian Nordic, in collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), is set to launch a clinical trial to evaluate the immunogenicity and safety of the MVA-BN vaccine in children aged 2-12. This initiative aims to potentially extend the vaccine's indication to younger populations, thereby broadening its protective reach.

Overall, Bavarian Nordic is dedicated to playing a critical role in global health by ensuring the availability of effective vaccines to control the mpox outbreak and protect vulnerable populations worldwide. The company's comprehensive efforts encompass expanding manufacturing capabilities, pursuing regulatory approvals, and conducting essential clinical studies to extend vaccine access across different age groups.