DUKORAL® Cholera Vaccine 2023
Valneva SE's DUKORAL® is an oral, inactivated vaccine for preventing diarrhea caused by Vibrio cholerae and/or heat-labile toxin-producing ETEC. DUKORA suspension and effervescent granules for oral suspension cholera vaccine (inactivated, oral). DUKORAL is authorized in Europe and Australia to protect against cholera and in Canada, Switzerland, New Zealand, and Thailand to protect against cholera and ETEC.
Oral cholera vaccines have been prequalified by the World Health Organization (WHO). Active immunization against disease caused by Vibrio cholerae serogroup O1 is advised for adults and children (2 years) who will be visiting endemic/epidemic areas.
France-based Valneva SE's strategy stems from its vision to contribute to a world where no one dies or suffers from a vaccine-preventable disease. Dukoral was initially produced by SBL Vaccine.
DUKORAL Indication
The U.S. CDC recommends vaccination for people traveling to or living in areas of active cholera transmission. Check CDC's Travel Health Notices to identify areas with active cholera transmission.
DUKORAL Dosage
Standard primary course for adults and children over six years: 2 doses; Children 2 to 6 should receive three doses. Doses are to be administered at intervals of at least one week but less than six weeks apart. The primary immunization course should be restarted if more than six weeks have elapsed between doses. Immunization should be completed at least one week before potential exposure to Vibrio cholerae O1.
Each dose of DUKORAL vaccine suspension (3ml) contains a total of 1.25 x 1011 bacteria of the following strains: Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 31.25 x 109 bacteria, Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 31.25x 109 bacteria, Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 31.25x 109 bacteria. Recombinant cholera toxin B subunit (rCTB) 1mg.
DUKORAL Warnings and Precautions
DUKORAL® confers protection specific to Vibrio cholerae serogroup O1. Immunization does not protect against V. cholerae serogroup O139 or other species of Vibrio. Administration of DUKORAL® should be postponed for subjects suffering from acute gastrointestinal illness or acute febrile illness. DUKORAL® is not recommended for use in children less than 2 years of age. Formaldehyde is used during the manufacturing process, and trace amounts may be present in the final product. Caution should be taken in subjects with known hypersensitivity to formaldehyde. DUKORAL® contains approximately 1.1 g sodium per dose, which patients should consider on a controlled sodium diet. The vaccine does not provide complete protection, and it is important to adhere to standard protective measures to avoid cholera.
DUKORAL News 2023
March 23, 2023 - The Company announced DUKORAL sales increased to €17.3 million in 2022 compared to €2.4 million in 2021.
March 8, 2023 - OCV vaccinations launched in Syria for about 1.7 million children.
February 24, 2023 - The WHO reported A request for approximately 700,000 doses of OCV was approved, and a vaccination campaign in affected Mozambique districts in Gaza, Niassa, Sofala, and Zambezia provinces.
September 30, 2022 - Cholera Vaccine: Recommendations of the U.S. CDC Advisory Committee on Immunization Practices.
DUKORAL Clinical Studies
Challenge studies in human volunteers provided the first demonstration of efficacy. The challenge study at the University of Maryland enrolled healthy participants aged 19–35. Participants receiving either WC-BS (with 5 mg of CTB) or WC were given three doses at 2-week intervals. In addition, Cimetidine was administered 3 h before receipt of the vaccine in addition to the sodium bicarbonate solution mixed with the vaccine. Vaccinated participants and unvaccinated controls were challenged with 2 × 106 El Tor Inaba V. cholerae (strain N16961) four weeks after completion of the third dose of WC (n = 9) and five weeks after completion of WC-BS (n = 11). The vaccine efficacy of WC was found to be 56%, and for WC-BS, 64% (Table 2). Among vaccinated participants in both groups that developed cholera, they had less severe illness compared to controls and complete protection from severe diarrhea [16].
