Bavarian Nordic Provides Update on the Mpox Vaccine Supply Situation

COPENHAGEN, Denmark, September 12, 2024 – Bavarian Nordic A/S (OMX: BAVA), the vaccine manufacturer of MVA-BN, the only approved non-replicating smallpox and mpox vaccine (marketed as JYNNEOS, IMVAMUNE and IMVANEX) today provided an update of its supply and manufacturing activities in support of the ongoing mpox outbreak.

Since the declaration of mpox as a Public Health Emergency of Continental Security (PHECS) by the Africa Centers for Disease Control (CDC) and the subsequent declaration of a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO), Bavarian Nordic has intensified the collaboration with global stakeholders to support the joint efforts to combat the mpox outbreak.

Importantly, thanks to donations from the European Commission, the U.S. government and Bavarian Nordic, the first doses of MVA-BN arrived last week in the Democratic Republic of Congo (DRC), the epicenter of the mpox outbreak. More than 250,000 doses have already been shipped, and further donations of more than 500,000 doses of MVA-BN have so far been pledged by other countries.

UNICEF and Africa CDC have indicated that there is an urgent need for sufficient vaccine to protect up to 1 million people in the high-risk areas of the DRC, while potentially up to 10-12 million doses could be required through 2025. Bavarian Nordic is committed to ensuring equitable access to its mpox vaccine, and in response to the current outbreak and the strong demand from governments and organizations, including HERA, Gavi, UNICEF and Africa CDC, the Company has prioritized the production of MVA-BN for the rest of the year to provide up to 2 million doses by year-end.

This decision has meant that certain existing orders for 2024 will be pushed out to 2025 to provide greater flexibility to fulfill additional urgent and imminent needs in other markets. While this will defer part of the planned revenue for 2024 into next year, new orders entered in the recent weeks will offset the deferred revenue, and thus the Company’s financial guidance for 2024 remains unchanged.

These new supply contracts include multi-year agreements with countries across different continents, including countries who have pledged vaccines for Africa. In addition, Bavarian Nordic has responded to the UNICEF emergency tender, calling for the immediate supply of up to 2 million doses in 2024, and has ongoing discussions with other organizations and individual governments around the globe.