Vaxchora Vaccine Approved for Cholera Prevention
June 10, 2016 – The U.S. Food and Drug Administration (FDA) approved Vaxchora™ manufactured by PaxVax. Vaxchora is a vaccine for prevention of cholera, an acute intestinal infection characterized by diarrhea acquired by ingesting contaminated water or food. Cholera is caused by serogroup O1 in adults, age 18 through 65 and the majority of cases are associated with foreign travel to endemic areas where the water and food supply is contaminated. Vaxchora is the only vaccine approved in the U.S. for protection against cholera. It will be supplied as an oral, single-dose, live attenuated vaccine that should be administered at least 10 days before travel to a cholera-affected area.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.