Source: FDA, National Drug Code (US) Revision Year: 2020
Vivotif (Typhoid Vaccine Live Oral Ty21a) is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi. Routine typhoid vaccination is not recommended in the United States of America. Selective immunization against typhoid fever is recommended for the following groups: 1) travelers to areas in which there is a recognized risk of exposure to S. typhi, 2) persons with intimate exposure (e.g. household contact) to a S. typhi carrier, and 3) microbiology laboratorians who work frequently with S. typhi (7). There is no evidence to support the use of typhoid vaccine to control common source outbreaks, disease following natural disasters or in persons attending rural summer camps.
Not all recipients of Vivotif will be fully protected against typhoid fever. Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms. The vaccine will not afford protection against species of Salmonella other than Salmonella typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treatment of acute infections with S. typhi.
One capsule is to be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37°C (98.6°F)] drink on alternate days, e.g., days 1, 3, 5 and 7. Immunization (ingestion of all 4 doses of Vivotif (Typhoid Vaccine Live Oral Ty21a) should be completed at least 1 week prior to potential exposure to S. typhi.
The blister containing the vaccine capsules should be inspected to ensure that the foil seal and capsules are intact. The vaccine capsule should not be chewed and should be swallowed as soon after placing in the mouth as possible. A complete immunization schedule is the ingestion of 4 vaccine capsules as described above.
The optimum booster schedule for Vivotif has not been determined. Efficacy has been shown to persist for at least 5 years. Further, there is no experience with Vivotif as a booster in persons previously immunized with parenteral typhoid vaccine. It is recommended that a re-immunization dose consisting of 4 vaccine capsules taken on alternate days be given every 5 years under conditions of repeated or continued exposure to typhoid fever (7).
Vivotif (Typhoid Vaccine Live Oral Ty21a) is not stable when exposed to ambient temperatures. Vivotif should therefore be shipped and stored between 2°C and 8°C (35.6°F–46.4°F). Each package of vaccine shows an expiration date. This expiration date is valid only if the product has been maintained at 2°C–8°C (35.6°F–46.4°F).
Store at 2-8°C (36-46°F) in a dry place and protected from light.
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