NEW DRUG: Vaxchora: oral cholera vaccine

Vaxchora: oral cholera vaccinecholera vaccine, live attenuated, oral; powder for oral suspension, supplied as a foil sachet of buffer and a foil sachet of active component (lyophilized Vibrio cholerae strain CVD 103-HgR), Bavarian Nordic Canada.INDICATIONS Active immunization against diarrheal disease caused by V. cholerae serogroup O1 in persons two to 64 years of age travelling to cholera-affected countries. Note: The vaccine has not been evaluated in cholera endemic areas, but it provides protection to vaccine recipients from nonendemic areas for cholera (e.g., Canada) travelling to areas with a threat of diarrheal disease caused by cholera.ACTION The vaccine elicits a local intestinal and serum vibriocidal antibody and memory B cell response which recognizes native cholera toxin and wild type V. cholerae. Onset of protection against cholera diarrhea can be expected one week after administration. Effectiveness has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of any prior cholera vaccine.DOSAGE Persons ≥ 2 years of age: A single oral dose administered orally at least 10 days before potential exposure to cholera. Duration of protection is unknown. Safety and effectiveness of revaccination have not been established.ADMINISTRATION Buffer component must be reconstituted with bottled water before use and then the active component is added to the buffer solution (see product monograph instructions). Drink the full dose within 15 minutes of reconstitution. Avoid eating or drinking one hour before and one hour after taking Vaxchora vaccine as this may interfere with the protective effect of the buffer.ADVERSE EFFECTS MOST COMMON: Tiredness, headache, nausea/vomiting, abdominal pain, lack of appetite. Vaccine-associated diarrhea may occur; it is typically mild and usually resolves spontaneously within two days. MOST SERIOUS: No serious adverse effects reported. Vaccine may be shed in the stool for at least seven days. Theoretical risk of transmitting the vaccine strain to nonvaccinated close contacts (e.g., household contacts); use caution when considering whether to administer the vaccine to individuals with immunocompromised close contacts.DRUG INTERACTIONS Do not administer Vaxchora to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination. Avoid oral or parenteral antibiotics for 10 days following vaccination with Vaxchora. Administer Vaxchora at least 10 days before beginning antimalarial prophylaxis with chloroquine. Separate administration times of Vaxchora and Vivotif (typhoid vaccine Ty21a gastroresistant capsules) by two hours, since buffer in Vaxchora may affect the gastrointestinal transit of Vivotif capsules.STORAGE Store buffer and active component sachets in the refrigerator (2°C–8°C). Protect from light and moisture. Sachets may be used if left out of the refrigerator for up to 12 hours prior to reconstitution, as long as they are not exposed to temperatures > 25°C.COMMENTS Vaxchora (live attenuated oral cholera vaccine) is the second cholera vaccine to be authorized for use in Canada, following Dukoral, which is an inactivated oral travellers’ diarrhea and cholera vaccine.

NEW DRUG: Vaxchora: oral cholera vaccine

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