COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S has announced a groundbreaking milestone with the U.S. Food and Drug Administration (FDA) granting approval for the freeze-dried formulation of JYNNEOS® (Smallpox and Mpox Vaccine, Live, Non-replicating). This approval is a significant step toward improving public health security, allowing for the prevention of smallpox and mpox diseases in adults aged 18 years and older. The freeze-dried version provides crucial advantages in storage and transportation, ensuring better preparedness against potential outbreaks.

The approval comes after a standard review of a supplemental Biologics License Application (sBLA) submitted in May 2024, which demonstrated that the freeze-dried formulation elicited comparable immune responses and safety as its liquid-frozen counterpart. The traditional liquid-frozen form, originally approved by the FDA in 2019, has stringent cold-chain requirements that can complicate stockpiling efforts.

Paul Chaplin, President and CEO of Bavarian Nordic, emphasized the importance of this development, stating, "Today’s FDA approval represents a significant milestone in our development of this next generation of JYNNEOS and in our collaborative efforts with the U.S. government to strengthen public health security. We are committed to continuing our support in protecting citizens from both existing and emerging health threats."

Bavarian Nordic has been involved with the U.S. government since 2003, focusing on the development and distribution of vaccines aimed at providing protection against smallpox and mpox. The vaccine is vital for all populations, particularly those with weakened immune systems who may be susceptible to complications from traditional vaccines based on replicating viruses.

Since its introduction under Project BioShield, a program initiated by Congress in 2004 to enhance national security against biological threats, JYNNEOS has been a crucial asset. Bavarian Nordic has regularly supplied the U.S. government with its liquid-frozen formulation since 2010 and responded to increasing concerns during the mpox outbreak from 2022-2023 by ensuring a robust stockpile.

The company is now partnered with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to produce the freeze-dried version of JYNNEOS. Manufacturing commenced in 2024, with the first batches expected to be distributed later this year.

JYNNEOS is the only approved smallpox vaccine suitable for people at high risk, including healthcare workers and immunocompromised individuals, amidst rising fears of bioterrorism and infectious disease spread. Comprehensive guidance has been developed by the CDC, allowing for pre- and post-exposure vaccination, enhancing the vaccine's utility as a public health tool.

While vaccination with JYNNEOS is generally safe, proper medical facilities must be available to address potential allergic reactions. Key side effects include local injection site reactions such as pain and redness, as well as systemic reactions including headaches and fatigue.

As the global landscape faces increasing health threats, the approval of Bavaria Nordic's innovative vaccine underscores the importance of preparedness and adaptive strategies in public health. This development is not only a victory for Bavarian Nordic but also represents a proactive step toward safeguarding national health against historical and emerging threats.