Bavarian Nordic Seeks FDA Approval for Freeze-Dried Smallpox and Mpox Vaccine

COPENHAGEN, Denmark, May 31, 2024 - Bavarian Nordic (OMX: BAVA) has announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA). The application seeks approval for a new freeze-dried formulation of JYNNEOS®, a vaccine used to prevent smallpox and mpox in adults 18 and older. The currently approved liquid-frozen version of JYNNEOS® received FDA approval in September 2019 and remains the only authorized mpox vaccine globally and the sole non-replicating smallpox vaccine in the U.S.

The existing liquid-frozen formulation requires stringent cold-chain logistics for storage and transportation. In contrast, the proposed freeze-dried version offers enhanced flexibility, including easier storage conditions and a longer shelf life, making it more suitable for long-term stockpiling. The sBLA submission is backed by clinical data from a Phase 3 lot consistency study and a Phase 2 study demonstrating bioequivalence between the freeze-dried and liquid-frozen formulations. Additional clinical and non-clinical data, including process development and manufacturing insights, were also included. Following a standard 10-month review period, the new formulation might secure approval by the first quarter of 2025.

Paul Chaplin, the President and CEO of Bavarian Nordic, stated, "Finalizing this submission is a significant milestone in evolving our smallpox/mpox vaccine and continuing our collaboration with the U.S. government to tackle public health challenges. The approval of this new freeze-dried formulation, ideal for long-term stockpiling, is expected to ensure future orders beyond our current contract, valued at nearly USD 300 million, with the U.S. government."

Bavarian Nordic maintains an active contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA), valued at USD 299 million, to supply freeze-dried doses of JYNNEOS® for stockpiling. This contract permits the production of freeze-dried doses before the formulation's licensure. Production commenced in the first quarter of 2024, aiming to fulfill the first contract option worth USD 119 million within the year. The company's financial guidance for 2024 remains unchanged, with additional options valued at USD 180 million pending BARDA's exercise. Some bulk vaccines initially manufactured under previous contracts were repurposed for liquid-frozen doses during the mpox outbreak in 2022-2023, necessitating new orders to meet the remaining freeze-dried option requirements.

About the smallpox/mpox vaccine

The MVA-BN (Modified Vaccinia Ankara-Bavarian Nordic) vaccine, known as JYNNEOS® in the U.S. and Switzerland, IMVAMUNE® in Canada, and IMVANEX® in the EU/EAA and the UK, is a non-replicating smallpox vaccine. Originally developed in collaboration with the U.S. government, it is suitable for the entire population, including immunocompromised individuals who cannot use traditional replicating smallpox vaccines. MVA-BN is indicated for adults at risk of smallpox or mpox infection.

Bavarian Nordic has been a longstanding supplier of this vaccine to the U.S. and Canada and numerous other countries for their national biological preparedness. During the 2022-2023 mpox outbreak, the company expanded vaccine access to over 70 countries worldwide.

About Bavarian Nordic

Bavarian Nordic is a fully integrated vaccine company dedicated to protecting and saving lives through innovative vaccines. The company is a global leader in smallpox and mpox vaccines, contributing to public health preparedness across the globe. Additionally, Bavarian Nordic maintains a strong portfolio of vaccines for travelers and endemic diseases.

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