Vaxchora: The First FDA-Approved Cholera Vaccination in the United States.
نویسندگان
چکیده
Vaxchora is the first vaccine approved by the Food and Drug Administration for the prophylaxis of cholera infection. Cholera, a potentially life-threatening bacterial infection that occurs in the intestines and causes severe diarrhea and dehydration, has a low incidence in the U.S., but a high incidence in Africa, Southeast Asia, and other locations around the world. These areas draw travelers from the U.S., so cholera can present in patients who return from visits to these regions. Previous means of prophylaxis included the use of doxycycline for the prevention of traveler's diarrhea, but doxycycline is not specific for cholera. With the approval of Vaxchora, a live attenuated, single-dose, oral suspension vaccine, travelers can now visit these areas with less chance of contracting the bacterium Vibrio cholerae, which causes cholera infections.
منابع مشابه
Strategies to Prevent Cholera Introduction during International Personnel Deployments: A Computational Modeling Analysis Based on the 2010 Haiti Outbreak
BACKGROUND Introduction of Vibrio cholerae to Haiti during the deployment of United Nations (UN) peacekeepers in 2010 resulted in one of the largest cholera epidemics of the modern era. Following the outbreak, a UN-commissioned independent panel recommended three pre-deployment intervention strategies to minimize the risk of cholera introduction in future peacekeeping operations: screening for ...
متن کاملThe FDA takes action against unapproved drugs.
Most prescription drugs marketed in the United States have been reviewed and approved by the Food and Drug Administration as required by law. Thousands of unapproved prescription drugs, however, are still being prescribed and sold. The FDA, as part of its drug safety efforts, is bolstering its efforts against unapproved drugs in the United States.
متن کاملScientific and regulatory reasons for delay and denial of FDA approval of initial applications for new drugs, 2000-2012.
IMPORTANCE Some new drug applications fail because of inadequate drug performance and others are not approved because the information submitted to the US Food and Drug Administration (FDA) is unsatisfactory to make that determination. Resubmission of failed applications is costly, delaying marketing approval and the availability of new drugs to patients. OBJECTIVE To identify the reasons that...
متن کاملVaccination strategies for epidemic cholera in Haiti with implications for the developing world.
In October 2010, a virulent South Asian strain of El Tor cholera began to spread in Haiti. Interventions have included treatment of cases and improved sanitation. Use of cholera vaccines would likely have further reduced morbidity and mortality, but such vaccines are in short supply and little is known about effective vaccination strategies for epidemic cholera. We use a mathematical cholera tr...
متن کاملAssessing the FDA via the Anomaly of Off - Label Drug Prescribing
I t is commonly thought that the U.S. Food and Drug Administration (FDA) regulates the use of all pharmaceutical drugs in the United States. In fact, most hospital patients are given drugs that are not FDA-approved for the prescribed use. The FDA does require that drugs undergo extensive testing before they are released onto the market and, if it concludes that a new drug is unsafe or not effec...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
عنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 42 10 شماره
صفحات -
تاریخ انتشار 2017