Emergent BioSolutions Inc. (EBS) today announced approval by the U.S. Food and Drug Administration (FDA) of the Prior Approval Supplement (PAS) submitted by the company for its oral cholera vaccine, Vaxchora® (Cholera Vaccine, Live, Oral). The PAS supports the change in storage conditions of the vaccine from frozen to refrigerated at 2-8°C and the transfer of bulk drug substance manufacturing from Emergent’s product development facility in San Diego to its manufacturing facility in Bern, Switzerland. The PAS also covers changes in labeling regarding these developments. The company’s oral cholera vaccine is the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease.
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