The oral cholera vaccine (mORCVAX) is prepared from Vibrio cholerae O1 strains (including classical and El Tor biotypes) and Vibrio cholerae O139 strain. The production process includes culturing bacteria in suitable media, inactivation by formaldehyde or heat, concentration by centrifugation or filtration, and complete removal of cholera toxin. The oral cholera vaccine dose is standardized by Lipopolysaccharide (LPS) content to ensure sufficient antigen for immunogenicity against cholera.
COMPOSITION
One 1.5 ml dose contains:
- cholerae O1, El Tor, Phil.6973 (formaldehyde-inactivated) …….. 600 E.U. LPS
- cholerae O139, 4260B (formaldehyde-inactivated) ……………… 600 E.U. LPS
- cholerae O1, Cairo 50 (formaldehyde-inactivated) ……………… 300 E.U. LPS
- cholerae O1, Cairo 50 (heat-inactivated) ………………………….. 300 E.U. LPS
- cholerae O1, Cairo 48 (heat-inactivated) ………………………….. 300 E.U. LPS
Thimerosal …………………………………………………………… ≤ 0.02% (w/v)
WHO buffer solution ………………………………………………… qs to 1.5 ml
INDICATIONS
– Vaccine is used for children over 2 years of age (≥ 24 months) and adults living in cholera-endemic areas.
– Individuals traveling to cholera-endemic regions.
CONTRAINDICATIONS
– Do not use in children under 2 years of age;
– Acute intestinal infections;
– Acute and chronic diseases in progressive stage;
– Patients receiving immunosuppressive or anticancer therapy;
– Individuals with allergy or hypersensitivity reaction to a previous mORCVAX dose must not take subsequent doses.
ADVERSE REACTIONS
– After administration: nausea, vomiting may occur;
– Rare adverse events: headache, abdominal pain, diarrhea, fever, etc.;
– These symptoms resolve spontaneously without treatment.
REPORT TO PHYSICIAN ANY UNDESIRABLE EFFECTS EXPERIENCED DURING USE.
PRECAUTIONS
Protection against cholera:
Not all vaccine recipients will be fully protected against cholera. This vaccine does not protect against diarrhea caused by other microorganisms. Therefore, in addition to completing the recommended vaccine schedule, individuals must also implement necessary hygiene measures to avoid exposure to contaminated food, unsafe drinking water, and ensure hand washing before meals and after using the toilet.
Pregnant women:
This vaccine should not be used during pregnancy unless clearly necessary and the benefits outweigh the risks.
Breastfeeding women:
No sufficient data are available. During outbreaks, oral cholera vaccine may be considered for this group.
– Do not administer vaccine to children under 2 years of age.
NOTE: Shake well before use. Opened vials must be used within 6 hours if stored aseptically at 2°C–8°C.
DIRECTIONS FOR USE AND DOSAGE
– Route: Oral administration.
– Dosage: 1.5 ml / dose.
Primary immunization: 2 doses, interval of 14 days.
Booster immunization: Before each cholera season, 2 doses, interval of 14 days.
DRUG INTERACTIONS
No sufficient studies available on interactions of mORCVAX.
Consider the following:
– Immunosuppressants and anticancer drugs (e.g., azathioprine, cyclosporine, prednisone, dexamethasone, etanercept, infliximab, tacrolimus, sirolimus…).
– Other oral vaccines or drugs: do not administer within 1 hour before or after mORCVAX.
– If taking other medications, consult a physician.
OVERDOSAGE AND MANAGEMENT
Studies on overdose are not feasible; no official reports of overdose exist.
In case of suspected or accidental overdose, consult a physician immediately.
STORAGE
– Store and transport at 2°C to 8°C.
– Do not use if vaccine has been frozen.
– Protect from direct sunlight.
SHELF LIFE
24 months from the date of manufacture when stored at 2°C to 8°C.
PRESENTATION
– Box of 10 vials × 1.5 ml – single-dose.
– Box of 10 vials × 7.5 ml – 5 doses.
APPLIED STANDARD
In-house standard.
NOTE: SHAKE WELL BEFORE USE.
DO NOT USE IF THE VACCINE HAS BEEN FROZEN.
KEEP OUT OF REACH OF CHILDREN.
READ THE INSTRUCTIONS CAREFULLY BEFORE USE.
