Bavarian Nordic Submits Supplemental BLA Seeking U.S. FDA Approval of Freeze-Dried Formulation of Smallpox and Mpox Vaccine
In a groundbreaking move, Bavarian Nordic A/S has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a freeze-dried formulation of JYNNEOS® aimed at preventing smallpox and mpox disease in adults aged 18 and older. This innovative formulation could revolutionize the way these diseases are prevented and managed.
What Makes the Freeze-Dried Formulation Special?
The liquid-frozen formulation of JYNNEOS® was previously approved by the FDA in 2019, making it the only approved mpox vaccine globally and the sole non-replicating smallpox vaccine sanctioned in the U.S. However, the freeze-dried formulation offers enhanced flexibility in terms of transportation, storage conditions, and shelf life, making it ideal for long-term stockpiling. This development could have far-reaching implications for public health preparedness.
Implications for Future Stockpiling and Public Health Preparedness
If the sBLA submission is successful, and the freeze-dried formulation receives approval, it could potentially be available as early as the first quarter of 2025. Bavarian Nordic’s partnership with the U.S. government on this project underscores the importance of developing vaccines tailored to address current and future public health challenges. The licensure of this new formulation could secure future orders, surpassing the current contract valued at nearly USD 300 million with the U.S. government. This strategic move ensures that the vaccine is readily available for stockpiling and distribution in times of need.