The FDA has approved a new freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating).

Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its mpox and smallpox vaccine. The company said the newly approved formulation ...

Spray-drying is fundamentally a wet process; the concentrated liquid atomizes and is then intensely dried by hot air. In contrast, freeze-drying skips that liquid phase altogether. Freeze-dried ...

The approval 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, the company said.

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 ...

This included a Phase II trial in 651 healthy volunteers who were given two doses of either the liquid-frozen vaccine or the freeze-dried counterpart. No statistical differences were observed ...