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Vaxchora FDA Approval History

Reviewed by J.Stewart B.Pharm. Last updated on Jun 20, 2016.

FDA Approved: Yes (First approved June 10, 2016)
Brand name: Vaxchora
Generic name: cholera vaccine, live, oral
Dosage form: Suspension for Oral Administration
Company: PaxVax Inc.
Treatment for: Cholera Prophylaxis

Vaxchora (cholera vaccine, live, oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults traveling to cholera-affected areas.

The efficacy of Vaxchora was demonstrated in a randomized, placebo-controlled human cholera challenge study of 197 adults. Vaxchora was shown to be effective in 90.3 percent of those challenged 10 days after vaccination, and 79.5 percent among those challenged three months after vaccination.

Vaxchora is administered orally as a single dose of approximately 100 mL at least 10 days before potential exposure to cholera. Travelers should also follow CDC recommendations for cholera-prevention including safe food and water practices, and frequent hand washing. Common side effects include tiredness, headache, abdominal pain, nausea/vomiting, lack of appetite, and diarrhea.

Development Timeline for Vaxchora

Jun 11, 2016Approval FDA Approves Vaxchora (Cholera Vaccine, Live, Oral) to Prevent Cholera in Travelers

Further information

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