Type: Oral, Inactivated Cholera and LT-producing ETEC Diarrhea Vaccine
Form: Oral Suspension
Manufacturer: Valneva Sweden AB
Distributor: Valneva Canada Inc.
Indications
Purpose: Prevention of diarrhea caused by Vibrio cholerae and heat-labile toxin-producing Enterotoxigenic Escherichia coli (LT-ETEC).
Recommended For: Adults and children from 2 years of age who are traveling to areas with a risk of cholera or LT-ETEC.
Contraindications
Allergies: Hypersensitivity to any component of the vaccine, including non-medicinal ingredients or the container.
Illness: Immunization should be deferred in cases of acute gastrointestinal or febrile illness.
Dosage and Administration
Primary Immunization:
Adults and Children 6+ Years: 2 oral doses at least 1 week apart.
Children 2 to 6 Years: 3 oral doses at least 1 week apart.
ETEC Diarrhea: 2 doses at least 1 week apart for all eligible ages.
Booster: Single dose for adults and children 6+ years if last dose was 2-5 years prior; complete primary series if more than 5 years. For children 2-6 years, a single dose within 6 months to 5 years of last dose.
Reconstitution and Administration:
Prepare buffer solution by dissolving the effervescent powder in water.
Shake vaccine vial and mix with buffer solution.
Drink mixture immediately; do not eat or drink for 1 hour before and after.
Storage and Stability
Storage: Refrigerate at 2°C to 8°C. Do not freeze. Stable at up to 25°C for 28 days cumulatively.
Post-Mixing: Consume within 2 hours.
Adverse Reactions
Common: Gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, vomiting.
Serious: Rare cases of anaphylaxis and hypersensitivity reactions.
Drug Interactions
Interactions: Avoid taking with food, drink, or other oral medications for 1 hour before and after administration. Separate administration of other oral vaccines by at least 8 hours.
Clinical Trials and Efficacy
Cholera: 85% protection in the first 6 months, 57% in the second year post-immunization.
ETEC: 67% protection against LT-ETEC diarrhea within the first 3 months.
Special Populations
Pregnant Women: Use only if benefits outweigh risks.
Breastfeeding: Can be administered.
Children Under 2 Years: Not recommended.
Geriatrics: Limited data, but may benefit due to higher risk of severe disease complications.
