PaxVax Scores FDA Priority Review for Cholera Vaccine
The FDA has granted priority review status to PaxVax’s single-dose cholera vaccine Vaxchora.
Vaxchora met Phase 3 primary endpoints and demonstrated efficacy in an immunogenicity study of adults between the ages of 46 and 64.
The FDA has identified cholera as one of the eligible neglected tropical diseases under its priority review voucher program. The potential of being granted a voucher was a significant incentive for PaxVax to develop the vaccine for the U.S. market, the company says.
If licensed, Vaxchora would be the only vaccine against cholera approved in the U.S.