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Currently, the company is conducting GLP studies that will set the stage for a 510(k) application by year end

"Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19." "Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing," the statement continued.

100 g of precipitated protein pellets was resuspended with 100 l of 100 mM TEAB