COPENHAGEN, Denmark, May 31, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for a freeze-dried formulation of JYNNEOS® to prevent smallpox and mpox disease in adults 18 years and older.
The FDA approved the liquid-frozen formulation of JYNNEOS® in September 2019. It is currently the only approved mpox vaccine worldwide and the sole non-replicating smallpox vaccine approved in the U.S. The freeze-dried version offers more flexibility in transportation, storage, and shelf life, making it ideal for long-term stockpiling.
The sBLA submission is supported by Phase 3 lot consistency study data and Phase 2 study results demonstrating equivalence between the freeze-dried and liquid-frozen formulations. Additional clinical and non-clinical data, including process development and manufacturing information, were also included. The review process for the sBLA typically takes 10 months, and approval for the freeze-dried formulation could be granted by the first quarter of 2025.
Paul Chaplin, President and CEO of Bavarian Nordic, expressed satisfaction with the submission, highlighting its importance in developing an advanced smallpox/mpox vaccine and the ongoing partnership with the U.S. government for public health solutions. The approval of this new formulation, optimized for long-term stockpiling, is expected to secure future orders beyond the current USD 300 million government contract.
Bavarian Nordic holds a USD 299 million contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) for the supply of freeze-dried JYNNEOS® doses for stockpiling. Production of these doses began in the first quarter of 2024 under this contract, aligning with the financial guidance for the year. Additional options worth USD 180 million are awaiting BARDA approval. Inventory repurposed for liquid-frozen doses during the 2022-2023 mpox outbreak will need replacement through new orders to fulfill the remaining freeze-dried option.
About the smallpox/mpox vaccine
MVA-BN (Modified Vaccinia Ankara-Bavarian Nordic) is a non-replicating smallpox vaccine and the only mpox vaccine approved in the U.S. and Switzerland (JYNNEOS®), Canada (IMVAMUNE®), the EU/EAA, and United Kingdom (IMVANEX®). Originally developed in collaboration with the U.S. government to provide a smallpox vaccine for the entire population, including those unsuitable for traditional replicating smallpox vaccines, MVA-BN is recommended for individuals at risk of smallpox or mpox infection.
Bavarian Nordic has been a key supplier of the vaccine to the U.S. and Canada and has supported over 70 countries worldwide during the 2022-2023 mpox outbreak.
Federal funding acknowledgements
This project received federal funding from the HHS Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201700019C.
About Bavarian Nordic
Bavarian Nordic is a vaccine company dedicated to protecting and saving lives through innovative vaccines. A global leader in smallpox and mpox vaccines, the company supplies governments to enhance public health preparedness and provides vaccines for travelers and endemic diseases. For more information, visit www.bavarian-nordic.com.
Forward-looking statements
This announcement contains forward-looking statements that may involve risks and uncertainties, potentially impacting actual results. Forward-looking statements cover our plans, objectives, goals, future events, and performance. All such statements are subject to qualifications and any accompanying cautionary statements. We do not commit to updating or revising forward-looking statements unless required by law.
Contacts
Europe: Rolf Sass Sørensen, VP Investor Relations, rss@bavarian-nordic.com, Tel: +45 61 77 47 43
US: Graham Morrell, Paddock Circle Advisors, graham@paddockcircle.com, Tel: +1 781 686 9600
Company Announcement no. 17 / 2024
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