Denmark's Bavarian Nordic said on Monday the U.S. Food and Drug Administration has approved a freeze-dried formulation of its ...
Yesterday the US Food and Drug Administration (FDA) approved a freeze-dried formulation of Bavarian Nordic's mpox vaccine, ...
The FDA has approved a new freeze-dried formulation of Jynneos (smallpox and mpox vaccine, live, non-replicating).
Jynneos was the first smallpox vaccine developed under Project BioShield, a program created by Congress in 2004 to accelerate ...
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Pharmaceutical Technology on MSNFDA approves Bavarian Nordic’s freeze-dried mpox and smallpox vaccineThe formulation allows for greater stockpiling, with Bavarian Nordic already working with the US Government to add to vaccine ...
According to Bavarian Nordic, the freeze-dried formulation has advantages in terms of transportation, storage, and shelf life compared with the liquid-frozen formulation, allowing for more ...
The Company has been contracted by the U.S Biomedical Advanced Research and Development Authority (BARDA) to develop and supply a freeze-dried version of JYNNEOS for stockpiling. Manufacturing under ...
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.
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 ...
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