VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
06/15/2016 - PDUFA Goal Date
12/23/2020 - FDA approval date
An advisory committee meeting was not convened during the review of this original BLA. Whether data from human cholera challenge studies in U.S. subjects could be sufficient to demonstrate the effectiveness of a cholera vaccine in U.S. travelers to endemic areas, who are at high risk for contracting the disease, was discussed during 1993 and 1998 VRBPAC meetings. In 1993, the Committee discussed the limitations of using data from clinical field trials of the CVD-103 HgR vaccine in endemic areas to predict the effectiveness of this vaccine in naïve U.S. travelers. During the 1998 VRBPAC meeting, failure of the CVD-103 HgR vaccine to show protection in the field trials was discussed, and the Committee agreed that human challenge studies could suffice to demonstrate effectiveness of a cholera vaccine in persons not previously exposed to cholera provided that studies were adequate, well-controlled and conducted under the provisions of GCP