FDA Approves Vaxchora for Cholera

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The CDC’s Advisory Committee on Immunization Practices voted unanimously to recommend Vaxchora for US travelers to areas of active cholera transmission.
The CDC’s Advisory Committee on Immunization Practices voted unanimously to recommend Vaxchora for US travelers to areas of active cholera transmission.

The US Food and Drug Administration (FDA) has approved Vaxchora™, a single-dose vaccine for protection against cholera.  Vaxchora is the only approved vaccine for use in the United States. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted unanimously to recommend the vaccine for adults traveling to cholera-affected areas, according to a press release.1

Vaxchora is an oral vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. It is approved for adults between the ages of 18 and 64 years.  The effectiveness of the vaccine has not been established in either persons living in cholera-affected areas or those who have pre-existing immunity to V cholerae. “Vaxchora has not been shown to protect against disease caused by V cholerae serogroup O139 or other non-O1 serogroups,” according to the press release.

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The FDA's approval of Vaxchora is based on results from a phase 3, randomized, double-blind, placebo-controlled challenge trial (ClinicalTrials.gov Identifier: NCT01895855).2 In this study, adults between the ages of 18 and 45 years were randomly assigned to receive either the vaccine (n=95) or placebo (n=102).  The primary end point was moderate (≥3.0 L) to severe (≥5.0 L) diarrheal purge. At 10 days the vaccine efficacy was 90.3% (P <.0001) and at 3 months 79.5% (P <.0001).

“We are excited that Vaxchora is now available to Americans traveling to areas affected by cholera.  This is particularly timely in light of the number of US citizens, including members of the US military, joining relief efforts in Haiti,” said Nima Farzan, Chief Executive Officer and President of PaxVax.

Vaxchora is not approved for use outside of the United States.

Reference

  1. PaxVax's Vaxchora™ now available as the only US-approved vaccine for protection against cholera [press release]. Redwood City, CA: PaxVax Inc.; October 24, 2016.
  2. Chen WH, Cohen MB, Kirkpatrick BD, et al. Single-dose live oral cholera vaccine CVD 103-hgR protects against human experimental infection with vibrio cholerae O1 el tor. Clin Infect Dis. 2016;62:1329-1335. doi: 10.1093/cid/ciw145.
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