We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
Vaxchora
Published
Product name
Vaxchora
Active ingredient
Vibrio cholerae
Submission type
New Biological Entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Vaxchora (vibrio cholerae) was approved for the following therapeutic use:
Vaxchora vaccine is indicated for active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older travelling to cholera-affected countries.
Vaxchora vaccine should be used in accordance with official recommendations.
The vaccine should not replace standard preventive hygiene measures.
How this medicine works
Vaxchora vaccine contains live attenuated cholera bacteria (V. cholerae O1 classical Inaba strain CVD 103-HgR). CVD 103-HgR was constructed from the serogroup O1 classical Inaba strain 569B by deleting the catalytic domain sequence of both copies of the ctxA gene, which prevents the synthesis of the toxic subunit A of cholera toxin, thus preventing synthesis of active cholera toxin (CT). This attenuated strain remains able to synthesise the immunogenic non-toxic B subunit of CT (encoded by the ctxB gene). In addition, a marker was inserted into the hemolysin gene locus (hlyA) to enable differentiation of the vaccine strain from wild type V. cholerae O1. CVD 103-HgR elicits a local intestinal and serum antibody response which recognizes native cholera toxin and wild type V. cholerae. Due to the inability of CVD 103-HgR to synthesise active cholera toxin subunit A, diarrheal disease normally associated with V. cholerae infection is absent.
Vaxchora vaccine replicates in the gastrointestinal tract of the recipient and induces serum vibriocidal antibody and memory B cell responses. Immune mechanisms conferring protection against cholera following receipt of Vaxchora vaccine have not been determined, however, rises in serum vibriocidal antibody 10 days after vaccination with Vaxchora vaccine were associated with protection in a human challenge study.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Vaxchora was considered favourable for the therapeutic use approved.
Sponsor