The U.S. Food and Drug Administration (FDA) has granted Emergent BioSolutions Inc. approval to change the storage conditions and manufacturing facility for its oral cholera vaccine, Vaxchora.
Specifically, the FDA’s approval of the Prior Approval Supplement (PAS) submitted by the company supports the change in storage conditions of the vaccine from frozen to refrigerated at 2-8°C. It also supports the transfer of bulk drug substance manufacturing from Emergent’s product development facility in San Diego, Calif., to its manufacturing facility in Bern, Switzerland, the company said on Tuesday. Further, the PAS covers changes in labeling regarding these developments.
Vaxchora is the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease.
“Emergent is pleased with this FDA approval that enables a more robust supply chain process for our oral cholera vaccine and maximizes capacity utilization of our manufacturing facilities,” Sean Kirk, executive vice president, manufacturing and technical operations at Emergent BioSolutions, said. “This development positions the company to expand into new markets as we prepare for European launch in 2020.”
Cholera is a disease that is transmitted by ingestion of food and water contaminated with Vibrio cholerae. It may lead to a broad range of symptoms, including diarrhea. In 2017, the U.S. Centers for Disease Control and Prevention recommended the use of Vaxchora in adults 18-64 years old traveling from the United States to areas of active cholera transmission.