Cholera Vaccine Announces Cold Storage Changes

The U.S. Food and Drug Administration (FDA) announced the approval of the Prior Approval Supplement (PAS) submitted by Emergent for its oral cholera vaccine, Vaxchora®. 

This PAS supports the change in storage conditions of the Vaxchora vaccine from frozen to refrigerated at 2-8°C. 

This storage change is important to extending the delivery of Vaxchora in under-developed areas. 

The Vaxchora 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. 

In the USA, Vaxchora is approved for use in adults 18 through 64 years of age, who are traveling to cholera-affected areas, such as Africa, Southeast Asia, and Haiti.   

Since 2010, a total of 23 cholera cases caused by toxigenic Vibrio cholerae O1 have been confirmed in the United States. Nearly all of the cholera cases reported in the USA are acquired during international travel. 

The World Health Organization estimates that only 5-10 percent of cases occurring annually are officially reported. Non-vaccine interventions to prevent cholera infection include the avoidance of contaminated water and food and frequent handwashing. 

But, the effectiveness of Vaxchora has limitations:

• Vaxchora has not been established in persons living in cholera-affected areas
• Vaxchora has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine
• Vaxchora has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups 

“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,” said Sean Kirk, executive vice president, at Emergent BioSolutions, in a press release.

Cholera is a potentially life-threatening bacterial infection that occurs in the intestines and causes severe diarrhea and dehydration, says the Centers for Disease Control and Prevention (CDC).

Approximately 10 percent of infected persons will have severe disease characterized by profuse watery diarrhea, vomiting, and leg cramps. In these people, the rapid loss of body fluids leads to dehydration and shock. 

Without treatment, death can occur within hours.

Previous cholera vaccine news:

• 2 Doses of Cholera Vaccine 76% Protective For 4 Years
• Two Million Cholera Vaccines For Five African Countries

For full Prescribing Information, please visit Vaxchora.

Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, deliberate, and naturally occurring public health threats.