EMERGENT | Vivotif

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Prescribing Information

VIVOTIF Role in Prevention

Efficacy and Safety of VIVOTIF

Dosage and Administration

Important Safety Information
VIVOTIF is contraindicated in patients with a hypersensitivity to any component of the vaccine or the enteric-coated capsule. The vaccine should not be administered to persons during an acute febrile illness. Safety of the vaccine has not been demonstrated in persons deficient in their ability to mount a humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment with immunosuppressive or antimitotic drugs. The vaccine should not be administered to these persons regardless of benefits.

Indications and Usage VIVOTIF is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella enterica serovar 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 an S. Typhi carrier; and 3) microbiology laboratorians who work frequently with S. Typhi. 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.

Warnings and Precautions Acute Gastrointestinal Illness: VIVOTIF is not to be taken during an acute gastrointestinal illness. Postpone taking the vaccine if persistent diarrhea or vomiting occurs.
Concomitant Administration with Sulfonamides and Antibiotics: The vaccine should not be administered to individuals receiving sulfonamides and antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response.
Diminished Immune Response: Unless a complete immunization schedule is followed, an optimum immune response may not be achieved. Not all recipients of VIVOTIF will be fully protected against typhoid fever.
Personal Precautions: Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms, i.e. travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water.
Concomitant Administration with Anti-malarial Drugs: Several anti-malaria drugs, such as mefloquine, chloroquine and proguanil (not approved for use in US) possess anti-bacterial activity which may interfere with the immunogenicity of VIVOTIF. A study showed that mefloquine and chloroquine can be administered together with VIVOTIF. Proguanil should be administered only if 10 days or more have elapsed since the final dose of VIVOTIF was ingested.
Adverse Reactions: The most common adverse reactions in clinical trials were abdominal pain (6.4%), nausea (5.8%), headache (4.8%), fever (3.3%), diarrhea (2.9%), vomiting (1.5%) and skin rash (1.0%). Only the incidence of nausea occurred at a statistically higher frequency in the vaccinated group as compared to the placebo group.

For more information about VIVOTIF, please see Full Prescribing Information.

EMERGENT®, VIVOTIF®, and any and all Emergent BioSolutions Inc. brands, products, services and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries.

© 2022 Emergent BioSolutions Inc. All rights reserved.

99 Min

Important Safety Information for VIVOTIF (Typhoid Vaccine, Live, Oral Ty21a)

Indication and Usage
VIVOTIF is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella enterica serovar 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 an S.Typhi carrier; and 3) microbiology laboratorians who work frequently with S.Typhi. 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.]

Important Safety Information
VIVOTIF is contraindicated in patients with a hypersensitivity to any component of the vaccine or the enteric-coated capsule. The vaccine should not be administered to persons during an acute febrile illness. Safety of the vaccine has not been demonstrated in persons deficient in their ability to mount a humoral or cell-mediated immune response, due to either a congenital or acquired immunodeficient state including treatment with immunosuppressive or antimitotic drugs. The vaccine should not be administered to these persons regardless of benefits.

Acute Gastrointestinal Illness: VIVOTIF is not to be taken during an acute gastrointestinal illness. Postpone taking the vaccine if persistent diarrhea or vomiting occurs.

Concomitant Administration with Sulfonamides and Antibiotics: The vaccine should not be administered to individuals receiving sulfonamides and antibiotics since these agents may be active against the vaccine strain and prevent a sufficient degree of multiplication to occur in order to induce a protective immune response.

Diminished Immune Response: Unless a complete immunization schedule is followed, an optimum immune response may not be achieved. Not all recipients of VIVOTIF will be fully protected against typhoid fever.

Important Safety Information
Personal Precautions: Vaccinated individuals should continue to take personal precautions against exposure to typhoid organisms (i.e., travelers should take all necessary precautions to avoid contact or ingestion of potentially contaminated food or water).

Concomitant Administration with Anti-malarial Drugs: Several anti-malaria drugs, such as mefloquine, chloroquine and proguanil (not approved for use in US) possess anti-bacterial activity which may interfere with the immunogenicity of VIVOTIF. A study showed that mefloquine and chloroquine can be administered together with VIVOTIF. Proguanil should be administered only if 10 days or more have elapsed since the final dose of VIVOTIF was ingested.

Adverse Reactions: The most common adverse reactions in clinical trials were abdominal pain (6.4%), nausea (5.8%), headache (4.8%), fever (3.3%), diarrhea (2.9%), vomiting (1.5%) and skin rash (1.0%). Only the incidence of nausea occurred at a statistically higher frequency in the vaccinated group as compared to the placebo group.