Oral Cholera Vaccine is used for active immunization against Vibrio cholerae. It can be administered to individuals aged 1 year and older. Safety and efficacy data for infants under 1 year of age are not available. Protection typically begins 7–10 days after completing the primary vaccination series. The vaccine has not demonstrated efficacy against Vibrio cholerae serogroup O139.

This oral cholera vaccine is a turbid, white to brownish suspension, free from aggregates and foreign particles. It contains the required quantities of V. cholerae O139 and O1 (serotypes Inaba and Ogawa), inactivated by heat and formaldehyde.

Each 1.5 ml contains Inactivated Oral Cholera Vaccine BP as:

• V. cholerae O1 Inaba Phil 6973 El Tor, Formaldehyde inactivated 600 LEU
• V. cholerae O1 Inaba Cairo 48, Heat inactivated 300 LEU
• V. cholerae O1 Ogawa Cairo 50, Formaldehyde inactivated 300 LEU
• V. cholerae O1 Ogawa Cairo 50, Heat inactivated 300 LEU
• V. cholerae O139 4260B, Formaldehyde inactivated 600 LEU

The recommended dose is 1.5 ml to be taken orally. The primary immunization schedule consists of two doses administered at an interval of at least two weeks. The vaccine must not be given parenterally (intramuscular, subcutaneous, or intravenous) and is intended for oral use only.

Method of administration: The vaccine is supplied as a suspension. Shake the vial well before use. Administer 1.5 ml directly into the mouth of the recipient. If necessary, it may be followed by water to ease ingestion. Alternatively, the vaccine may be given using a disposable syringe (without needle) by transferring the contents into the mouth. Parenteral administration is strictly prohibited.

Cholera vaccine should not be given to individuals with known hypersensitivity to any component of the vaccine or those who have previously shown allergic reactions after receiving the vaccine. Formaldehyde is used during the manufacturing process, and trace amounts may remain in the final product; therefore, caution is advised in individuals with known sensitivity to formaldehyde. As with other vaccines, administration should be postponed in individuals with acute illness, including acute gastrointestinal or febrile conditions. However, minor illnesses such as mild upper respiratory tract infections are not a reason to delay vaccination.

The following adverse effects may occur with cholera vaccination: acute gastroenteritis, diarrhea, fever, vomiting, abdominal pain, itching, rash, nausea, weakness, cough, vertigo, dryness of mouth, oral ulcer (rare), sore throat (rare), and yellow discoloration of urine (rare). It has been observed that adverse effects are generally less frequent after the second dose compared to the first dose.

There are no adequate clinical studies evaluating the safety and immunogenicity of cholera vaccine in pregnant women or its effects on the fetus. However, the vaccine may be administered to pregnant or breastfeeding women after careful consideration of potential benefits and risks, particularly during medical emergencies or outbreaks.

Vaccination should be carried out after reviewing the medical history (particularly previous vaccinations and any adverse reactions) and performing a clinical assessment. As with all vaccines, the cholera vaccine may not provide complete protection to every individual. It is not a substitute for treatment in individuals suspected of having cholera or presenting with symptoms of acute gastrointestinal illness or severe watery diarrhea. Individuals with weakened immune systems (due to disease or immunosuppressive therapy) may have a reduced immune response to the vaccine. If feasible, vaccination should be postponed until completion of immunosuppressive treatment, based on medical advice. As with any vaccination, appropriate medical support should be readily available to manage rare anaphylactic reactions. Therefore, it is recommended that the recipient remains under medical observation for at least 30 minutes after vaccination.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the reach and sight of children. Store at +2°C to +8°C. Transport should also be maintained at +2°C to +8°C. Do not freeze. Discard the vaccine if frozen. Protect from light.