Vaxchora

What it is

Vaxchora contains 4 x 10⁸ to 2 x 10⁹ attenuated Vibrio cholerae bacteria cells (CVD 103-HgR strain) , which is produced by recombinant DNA technology . Vaxchora is provided in a sachet as a powder for suspension, with an accompanying sachet containing effervescent powder (buffer) . It is administered by oral use .

Approved indications

— Active immunisation against disease caused by Vibrio cholerae serogroup O1 in adults and children aged 2 years and older travelling to cholera-affected countries .

Dosing overview

A single oral dose should be administered at least 10 days prior to potential exposure to cholera . For children aged 2 to 5 years, half (50 mL) of the buffer solution should be used . The dose should be drunk within 15 minutes of reconstitution . Eating and drinking should be avoided for 60 minutes before and after oral ingestion of Vaxchora vaccine . The safety and effectiveness of revaccination with Vaxchora have not been established .

Key safety warnings

Vaxchora confers protection specific to Vibrio cholerae serogroup O1, and immunisation does not protect against V. cholerae O139 or other non-O1 serogroups . Duration of protection is unknown . As with any vaccine, immunisation with Vaxchora will not provide 100% protection . Vaxchora contains live attenuated cholera bacteria that replicate in the gastrointestinal tract, and in individuals with acute gastroenteritis, vaccination should be postponed until after recovery because protection against cholera may be diminished . The degree of protection and the effects of vaccination in individuals with chronic gastrointestinal disease are unknown . Vaxchora shedding in the stools was observed in 11.3% of vaccine recipients during the first 7 days post-vaccination; the duration of shedding is unknown, and there is a potential for transmission of the vaccine strain to non-vaccinated close contacts . Concomitant administration with systemic antibiotics should be avoided; Vaxchora should not be administered to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination, and oral or parenteral antibiotics should be avoided for 10 days following vaccination . Immune responses and protection may be diminished when Vaxchora is administered concomitantly with chloroquine; administer Vaxchora at least 10 days before beginning antimalarial prophylaxis with chloroquine . Patients with rare hereditary problems of galactose intolerance, congenital lactase deficiency, glucose-galactose malabsorption, fructose intolerance, or sucrose-isomaltase insufficiency should not take this vaccine . The vaccine contains 863 mg of sodium per dose, equivalent to 43% of the WHO recommended maximum daily intake of 2 g of sodium for an adult .

Contraindications

Hypersensitivity to the active substance or to any of the excipients . Allergic reaction to previous ingestion of Vaxchora vaccine . Individuals with congenital immune deficiency or receiving immunosuppressive drugs or treatments .

Regulatory history

Vaxchora received TGA approval on 2023-09-04 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 . The medicine was first listed on the ARTG on 2023-09-06 .