VAXCHORA®

Product Information

• Name: VAXCHORA®
• Type: Cholera Vaccine, Live Attenuated, Oral
• Form: Oral suspension after reconstitution
• Manufacturer: Emergent Travel Health Inc.
• Distributor: Emergent BioSolutions Canada Inc.

Indications

• Purpose: Active immunization against diarrhea caused by Vibrio cholerae serogroup O1.
• Use: Recommended for individuals aged 2 to 64 years traveling to cholera-affected countries.

Contraindications

• Severe allergic reaction to any component of the vaccine or a previous dose of cholera vaccine.

Dosage and Administration

• Dose:
  • Single oral dose a minimum of 10 days before potential exposure.
  • Reconstitute with buffer component (sachet 1) followed by the active component (sachet 2).
• Reconstitution:
  • Mix the buffer component with 100 mL of cold or room temperature bottled water.
  • Add the active component to the buffer solution and stir for at least 30 seconds.
  • Consume within 15 minutes of reconstitution.
  • Avoid eating or drinking one hour before and after taking the vaccine.

Storage and Stability

• Storage: Refrigerate at 2°C to 8°C. Can be kept at or below 25°C for up to 12 hours prior to reconstitution.
• Post-Reconstitution: Use immediately; discard if not used within 15 minutes.

Adverse Reactions

• Common: Tiredness, headache, nausea/vomiting, abdominal pain, lack of appetite, diarrhea.
• Severe: Rare, includes severe diarrhea, fever, and potentially life-threatening reactions.
• Clinical Trial Data: Most adverse reactions were mild and resolved within a few days. No serious adverse events were attributed to the vaccine.

Special Populations

• Pregnant Women: Use only if benefits outweigh risks due to limited data.
• Breastfeeding: Unknown if excreted in human milk; use with caution.
• Children under 2 years: Safety and efficacy not established.
• Geriatrics (65 years and older): No data available, but this group is at higher risk for severe cholera complications.

Warnings and Precautions

• Transmission: Live vaccine may be shed in stool for at least 7 days; caution advised around immunocompromised contacts.
• Immune Response: Avoid administration with antibiotics or chloroquine as it may diminish vaccine effectiveness.

Efficacy

• Onset of Protection: Expected one week after administration.
• Challenge Studies: Demonstrated significant protection against cholera diarrhea at 10 days and 3 months post-vaccination.