Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS^® (Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak.

The approval follows a standard review with the FDA of a supplemental Biologics License Application (sBLA) submitted in May 2024. The sBLA was primarily based on clinical data that showed comparability in terms of the immune responses and safety between the freeze-dried and liquid-frozen formulations, as well as other non-clinical and manufacturing data.

The current liquid-frozen formulation of JYNNEOS, approved by the FDA in September 2019, has specific cold-chain requirements, while the freeze-dried formulation provides advantages in terms of transportation, storage conditions and shelf life, all of which are important factors for long-term stockpiling.

“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.” said Paul Chaplin, President and CEO of Bavarian Nordic. “As a long-term supplier of JYNNEOS to the U.S. biological preparedness, we are committed to continue supporting the government’s efforts to protect its citizens against current and future public health threats.”