Bavarian Nordic Provides Statement on Mpox Vaccine Supply and Collaboration with African and Global Stakeholders

COPENHAGEN, Denmark, August 17, 2024 - Bavarian Nordic A/S (OMX: BAVA) provides an update on plans for securing supply of vaccines to tackle the current mpox outbreak that the Africa Centers for Disease Control and Prevention (Africa CDC) declared as a Public Health Emergency of Continental Security (PHECS) on August 13, 2024 followed by the World Health Organization (WHO) that declared mpox as a Public Health Emergency of International Concern (PHEIC) on August 14, 2024.

"Bavarian Nordic is working closely with all stakeholders to ensure the equitable access to our mpox vaccine during the current PHECS and PHEIC. Importantly, we have built a strong partnership with the Africa CDC, both on supply, but also expanding our manufacturing network to include Africa. We are also working with the WHO on a regulatory path to ensure access to all countries, while in parallel seeking approval for use in adolescents and conducting clinical studies in Africa to further expand the use to children. We are prepared to work with the Africa CDC and the international community to play our role in protecting and saving lives around the World and to contain the latest outbreak," said Paul Chaplin, President & CEO of Bavarian Nordic.

Through partnerships with many governments and organizations like HERA and PAHO, Bavarian Nordic supplied more than 15 million doses of the mpox vaccine to more than 76 countries around the World during the mpox PHEIC in 2022/23. This equitable access to vaccine played a role in containing that outbreak and the vaccine was shown to be highly effective after 1 or 2 vaccinations and reduced the severity of the disease as judged by a reduction in hospitalizations.

Since 2022, Bavarian Nordic has created a vaccine inventory to provide a surge capacity for potential outbreaks. In response to recent events, the company also plans to ramp-up vaccine manufacturing to ensure the continued equitable access to the mpox vaccine. Consequently, the company has informed the Africa CDC that it has the capacity to manufacture 10 million doses by the end of 2025, in addition to current orders, and could already supply up to 2 million doses this year.

It would appear that mpox will remain a constant threat to public health, and the company is working closely with the Africa CDC to further expand the manufacturing capacity to produce the mpox vaccine in Africa though transfer of technology to selected African manufacturers.

As the majority of the current mpox cases in Africa occur in individuals younger than 18 years old, Bavarian Nordic recently submitted clinical data to EMA to potentially support the use of the mpox vaccine in adolescents (12-17-year-olds). These data were generated through a collaboration with the NIAID, a division of the U.S. National Institutes of Health (NIH), on a clinical study in more than 300 individuals, 12-17 years of age (NCT05740982). Furthermore, through a collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI), the company will shortly initiate a clinical trial to assess the immunogenicity and safety of MVA-BN in children from 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations.

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About Bavarian Nordic
Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. We are a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and have a strong portfolio of vaccines for travelers and endemic diseases. For more information visit www.bavarian-nordic.com.

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2024-08-17-en

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