Important Safety Information for Vaxchora® (Cholera Vaccine, Live, Oral)

Indication and Usage

VAXCHORA is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in persons 2 through 64 years of age traveling to cholera-affected areas.
Limitations of Use: The effectiveness of VAXCHORA has not been established in persons living in cholera-affected areas. The effectiveness of VAXCHORA has not been established in persons who have pre-existing immunity due to previous exposure to V. cholerae or receipt of a cholera vaccine. VAXCHORA has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

Important Safety Information

VAXCHORA is contradicted in persons who have a history of severe allergic reaction (e.g., anaphylaxis) to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine.

Altered Immunocompetence: The safety and effectiveness of VAXCHORA have not been established in immunocompromised persons and the immunologic response to VAXCHORA may be diminished in immunocompromised individuals.

Shedding and Transmission: Because VAXCHORA may be shed in the stool of recipients for at least 7 days and the vaccine strain can potentially be transmitted to non-vaccinated close contacts (e.g., household contacts), use caution when considering whether to administer VAXCHORA to individuals with immunocompromised close contacts.

Adverse Reactions: In adults 18-45 years old, the most common adverse reactions (incidence > 3%) were tiredness (31%), headache (29%), abdominal pain (19%), nausea/vomiting (18%), lack of appetite (17%) and diarrhea (4%).

The most common adverse reactions for children and adolescents (incidence ≥10%) were:
• Cohort 1 - age 12-<18 years: headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%) and nausea

The most common adverse reactions for children and adolescents (incidence ≥10%) were:
• Cohort 1 - age 12-<18 years: headache (45%), tiredness (41%), abdominal pain (38%), lack of appetite (29%) and nausea (22%) Cohort 2 - age 6-<12: tiredness (35%), abdominal pain (27%), headache (26%), lack of appetite (15%) and nausea (14%)
• Cohort 3 - age 2-<6: tiredness (31%), lack of appetite (19%), and abdominal pain (17%)

Antibiotics: Avoid concomitant administration of VAXCHORA with oral systemic antibiotics since these agents may be active against the vaccine strain. Do not administer VAXCHORA to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.

Antimalarial Prophylaxis: Immune responses to VAXCHORA may be diminished when administered concomitantly with chloroquine. Administer VAXCHORA at least 10 days before beginning chloroquine.

Immunosuppressive Treatments: Immunosuppressive therapies may reduce the immune response to VAXCHORA.