Bavarian Nordic A/S has announced that HERA, the European Health Emergency Preparedness and Response Authority, has placed a significant order for the company's MVA-BN® vaccine to address the ongoing mpox outbreak in Africa. HERA will acquire 175,420 doses for the Africa CDC to enhance their response to the spreading outbreak. Additionally, Bavarian Nordic will contribute 40,000 doses to HERA for the same purpose.
This donation follows a prior commitment of 15,000 doses by Bavarian Nordic, coordinated with Gavi, WHO, and UNICEF, to support the region. Currently, only two African nations have authorized emergency use of the MVA-BN vaccine. However, the WHO recently requested Bavarian Nordic to submit an Expression of Interest for Emergency Use Listing, which could expedite the vaccine's availability in countries lacking national regulatory approvals.
The Africa CDC has declared a Public Health Emergency of Continental Security to intensify the public health response to mpox across the continent. Stella Kyriakides, European Commissioner for Health and Food Safety, highlighted the importance of global partnerships and the collective effort to make 215,000 vaccines available to protect vulnerable populations in Africa.
Paul Chaplin, President and CEO of Bavarian Nordic, emphasized the urgency of the mpox spread in Africa and expressed pride in supporting HERA's vaccine contribution. He also acknowledged the efforts of Africa CDC and WHO in strengthening the public health response, ensuring wider access to the vaccine on the African continent.
The new order from HERA will not impact Bavarian Nordic's financial guidance for 2024 but brings the total value of secured contracts closer to the lower end of the revenue guidance for the Public Preparedness business for the year, with an expected revenue of DKK 5,000-5,300 million.
HERA, established by the European Commission in 2021, aims to bolster Europe's capability to prevent and respond to cross-border health emergencies through the development, procurement, and distribution of essential medical countermeasures. HERA's commitments extend beyond Europe, supporting health crises globally.
Bavarian Nordic has collaborated with HERA since the 2022 mpox outbreak, starting with direct procurement agreements and later through a joint procurement agreement. This partnership has allowed EU Member States, European Economic Area countries, and Western Balkan nations to obtain the mpox vaccine for national use.
The MVA-BN vaccine, also known as Modified Vaccinia Ankara-Bavarian Nordic, is a non-replicating smallpox vaccine and the only mpox vaccine approved by the FDA and EMA. Marketed under different names such as JYNNEOS® in the U.S. and Switzerland, IMVAMUNE® in Canada, and IMVANEX® in the EU/EEA and UK, it was developed in collaboration with the U.S. government. The vaccine is suitable for individuals, including those who cannot receive traditional replicating smallpox vaccines, and is indicated for the general adult population at risk for smallpox or mpox.
During the 2022-2023 mpox outbreak, the MVA-BN vaccine received Emergency Use Authorization from the U.S. FDA for pre- and post-exposure use in adolescents. Bavarian Nordic has been a long-term supplier of the vaccine to the U.S., Canada, and several other countries, enhancing their national biological preparedness. During the outbreak, Bavarian Nordic expanded vaccine access to over 70 countries, supporting governments and international organizations.
Bavarian Nordic is a leading vaccine company dedicated to protecting lives through innovative solutions, with a strong portfolio that includes vaccines for travelers and endemic diseases.
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