Where typhoid fever is endemic and could compromise the safety of food and water, VIVOTIF may provide at least 5 years of protection1
Why VIVOTIF?1
VIVOTIF is indicated for immunization of adults and children greater than 6 years of age against disease caused by Salmonella typhi (S. typhi). Routine typhoid vaccination is not recommended in the United States. Selective immunization against typhoid fever is recommended for the following groups:
Travelers to areas where
there is a recognized risk of
exposure to S. typhi
Persons with intimate
exposure (e.g., household
contact) to an S. typhi carrier
Microbiology laboratory workers who
frequently handle 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.
The Centers for Disease Control and Prevention (CDC) recommends typhoid vaccination for travelers to parts of the world where typhoid is common, people in close contact with a typhoid carrier, and laboratory workers who work with S. typhi bacteria.2
To read the full recommendation and see the most recent updates, visit the CDC website.
CDC RecommendationEstablished Efficacy1
Results from clinical studies indicate that adults and children greater than 6 years of age may be protected against typhoid fever following the oral ingestion of 4 doses of VIVOTIF (Typhoid Vaccine Live Oral Ty21a). The efficacy of the S. typhi Ty21a strain has been evaluated in a series of randomized, double-blind, controlled field trials. Not all recipients of VIVOTIF will be fully protected against typhoid fever.
Immune response
The precise mechanism(s) by which VIVOTIF provides protection against typhoid fever is unknown; however, it is known that immunization of adult subjects can elicit an antibody response against S. typhi.
An open study comparing levels of anti–S. typhi antibodies after the ingestion of 3 doses of vaccine between adults living in an endemic area (Chile) and nonendemic areas (United States and Switzerland) showed comparable seroconversion rates between these groups.
Challenge studies in North American volunteers have shown that the Ty21a strain is capable of providing significant protection to an experimental challenge of S. typhi.
Because of the very low incidence of typhoid fever in U.S. citizens, efficacy studies were not feasible in this population; however, the above observations support the expectation that 4 doses of VIVOTIF will provide protection to recipients from non–typhoid-endemic areas, such as the United States.
Duration of efficacy
- Efficacy of VIVOTIF has been shown to persist for at least 5 years
- It is recommended that reimmunization be given every 5 years under conditions of repeated or continued exposure to
typhoid fever - There is no experience with VIVOTIF as a booster in persons previously immunized with parenteral typhoid vaccine
- The optimum booster schedule for VIVOTIF has not been determined
Adverse Reactions From Clinical Trials1
Active surveillance for adverse reactions of enteric-coated capsules was performed in a pilot study and in a subgroup of a large field trial involving a total of 483 individuals receiving 3 vaccine doses.
Adverse reaction
Symptom rate (%) N=483
aOnly the incidence of nausea occurred at a statistically higher frequency in the vaccinated group as compared with the placebo group.
Adverse Reactions From Postmarketing Surveillance1
More than 150 million doses of VIVOTIF have been marketed worldwide.
Adverse reactions reported between 1991 and 1995, during which time more than 60 million doses (capsules) were administered, included diarrhea (n=45), abdominal pain (n=42), nausea (n=35), fever (n=34), headache (n=26), skin rash (n=26), vomiting (n=18), or urticaria in the trunk and/or extremities (n=13). One isolated, nonfatal anaphylactic shock, which was considered to be an allergic reaction to the vaccine, was reported.
Dosage and Administration1
Dosage and administration instructions should be explained carefully to help patients stay on course with VIVOTIF.
Capsules are taken on Days 1, 3, 5, and 7, and completed at least 1 week before travel to areas endemic for typhoid fever.
Dos and Don’ts of Taking VIVOTIF1
To ensure your patients know how to take VIVOTIF appropriately, be sure to share the following tips during consultations:
DO
- Complete the course of VIVOTIF at least 1 week before potential exposure to S. typhi. A complete immunization schedule is the ingestion of 4 vaccine capsules as described above
- Keep the capsules refrigerated (35.6°F–46.6°F)
- Inspect the blister containing the vaccine capsules to ensure that the foil seal and capsules are intact
- The vaccine capsule should be swallowed approximately 1 hour before a meal with cold or lukewarm (temperature not to exceed body temperature, e.g., 37°C [98.6°F]) drink
- Swallow the vaccine capsule as soon after placing in the mouth as possible
DON'T
DON’T take with
sulfonamides or antibiotics, as these medications may decrease the effectiveness of the vaccine
DON’T open or
chew the capsules
DON’T freeze
the capsules
Administering oral polio or yellow fever vaccines at the same time as VIVOTIF does not suppress the immune response triggered by VIVOTIF. There are no data regarding simultaneous administration of other parenteral vaccines or immunoglobulins with VIVOTIF. Please refer to the CDC Morbidity and Mortality Weekly Report for additional information on concomitant use.
For medical inquiries about administering VIVOTIF, please contact Medical Information at (844) 422-8274 or medical.information_na@bavarian-nordic.com.
How Supplied/Storage and Handling1
How supplied1
VIVOTIF is supplied in a single foil blister containing 4 doses of vaccine in a single package.
Storage and handling1
- VIVOTIF is not stable when exposed to ambient temperatures, so VIVOTIF should be shipped and stored refrigerated between 35.6°F–46.6°F
- Each package of vaccine shows an expiration date. This expiration date is valid only if the product has been maintained at the proper temperature
For medical inquiries regarding temperature deviations by patients, please contact Medical Information at
(844) 422-8274 or medical.information_na@bavarian-nordic.com.
Visit the Resources page for more information about VIVOTIF.
View NowIndication and Usage
VIVOTIF 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 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
Contraindications
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.
Warnings and Precautions
Acute Gastrointestinal Illness: VIVOTIF is not to be taken during an acute gastrointestinal illness.
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.
Administration in Patients With Diarrhea or Vomiting: Vaccination should be postponed if persistent diarrhea or vomiting is occurring.
Need to Complete the Entire Vaccination Series of 4 Doses on the Correct Schedule: 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.
Not All Recipients Will Be Protected — Need for Safety Vigilance: 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 (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 (approved in the United States as 1 of the 2 active ingredients in Malarone and its generic equivalents) possess anti-bacterial activity, which may interfere with the immunogenicity of VIVOTIF. A study in healthy adults 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.
Pregnancy/Nursing: It is not known whether VIVOTIF can cause fetal harm when administered to pregnant women or can affect reproduction capacity. VIVOTIF should be given to a pregnant woman only if clearly needed. There are no data to warrant the use of this product in nursing mothers. It is not known if VIVOTIF is excreted in human milk.
Adverse Reactions
In 2 trials conducting active surveillance for adverse reactions in persons receiving 3 doses (VIVOTIF recipients in the safety dataset, n=483), the most common adverse reactions 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. Reports to the manufacturer from early post-marketing clinical experience (1991-1995), during which time over 60 million doses (capsules) were administered, included all the adverse reactions identified above, as well as urticaria in the trunk and/or extremities (n=13), and 1 isolated, non-fatal case of anaphylactic shock considered to be an allergic reaction to the vaccine.
To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.
Please see full Prescribing Information.
References:
- VIVOTIF (Typhoid Vaccine Live Oral Ty21a) [package insert]. Redwood City, CA: Emergent Travel Health Inc.
- Typhoid vaccine: what you need to know. Centers for Disease Control and Prevention. Updated October 30, 2019. Accessed January 5, 2024. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/typhoid.html
Indication and Usage
VIVOTIF 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 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
Contraindications
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.
Warnings and Precautions
Acute Gastrointestinal Illness: VIVOTIF is not to be taken during an acute gastrointestinal illness.
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.
Administration in Patients With Diarrhea or Vomiting: Vaccination should be postponed if persistent diarrhea or vomiting is occurring.
Need to Complete the Entire Vaccination Series of 4 Doses on the Correct Schedule: 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.
Not All Recipients Will Be Protected — Need for Safety Vigilance: 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 (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 (approved in the United States as 1 of the 2 active ingredients in Malarone and its generic equivalents) possess anti-bacterial activity, which may interfere with the immunogenicity of VIVOTIF. A study in healthy adults 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.
Pregnancy/Nursing: : It is not known whether VIVOTIF can cause fetal harm when administered to pregnant women or can affect reproduction capacity. VIVOTIF should be given to a pregnant woman only if clearly needed. There are no data to warrant the use of this product in nursing mothers. It is not known if VIVOTIF is excreted in human milk.
Adverse Reactions
In 2 trials conducting active surveillance for adverse reactions in persons receiving 3 doses (VIVOTIF recipients in the safety dataset, n=483), the most common adverse reactions 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. Reports to the manufacturer from early post-marketing clinical experience (1991-1995), during which time over 60 million doses (capsules) were administered, included all the adverse reactions identified above, as well as urticaria in the trunk and/or extremities (n=13), and 1 isolated, non-fatal case of anaphylactic shock considered to be an allergic reaction to the vaccine.
To report SUSPECTED ADVERSE REACTIONS, contact Bavarian Nordic at 1-844-4BAVARIAN or the US Department of Health and Human Services by either visiting www.vaers.hhs.gov/reportevent.html or calling 1-800-822-7967.
These Terms and Conditions govern the VIVOTIF® Dose Replacement Program (the “Program”) operated by Emergent Travel Health (“Emergent”).
Program Participation Eligibility:
The Program will be available, subject to these Terms and Conditions, to health care practitioners (“Program Participants”) who (i) have purchased VIVOTIF either directly from Emergent or from a third party who purchased the product from Emergent, (ii) have patients who have improperly administered and/or stored VIVOTIF (as determined by Emergent in its sole discretion) and who the Program Participants have directed to restart taking VIVOTIF and (iii) comply with these Terms and Conditions. Emergent has the sole authority to determine eligibility for participation in the Program.
Product Eligibility:
The Program is available for doses of VIVOTIF which have been improperly administered or stored by patients of Program Participants so long as the patients have been directed by the Program Participant to restart taking VIVOTIF. In order to receive credit or replacement product for VIVOTIF, Program Participants must contact Emergent Medical Information at medicalinformation@ebsi.com or 1-800-533-5899 to determine the viability of the improperly administered or stored doses of VIVOTIF.
For the avoidance of doubt, the Program is not available for, and no credit or replacement product will be issued in respect of, (i) any product for which a patient has not been directed to restart taking VIVOTIF, (ii) any lost or misplaced product or any product for which a patient has experienced an adverse reaction or side effect but which has not been improperly administered or stored, (iii) any product (whether administered or unused) for which reimbursement has been or will be requested or collected or (iv) any product damaged as a result of unforeseen power outages, natural disasters or other emergency situations.
Program Participants may request credit or replacement product for VIVOTIF satisfying the criteria set forth herein for up to five units of VIVOTIF (each unit contains four doses) during each calendar year. Emergent has the sole authority to determine product eligibility for the Program.
Enrollment and Requests for Credit or Replacement Product:
Program Participants are required to enroll in the Program and request a credit or product replacement from Emergent by fully and accurately completing the Program Administration Form available on the Product Replacement Program section of our site and by submitting the completed and signed form to Emergent Customer Care via facsimile at 800-392-9490, e-mail at customercare@ebsi.com, or online at the Product Replacement Program section of our site.
Issuance of Credit or Product Replacement:
Emergent will determine, in its sole discretion, whether any submitted request complies with these Terms and Conditions, whether to accept or reject any submitted request and whether to issue a credit or product replacement. Credits will only be available for Program Participants who have purchased VIVOTIF directly from Emergent. For all other Program Participants, only product replacement will be available under the Program. In the event Emergent elects to accept a request and issue a credit, such credit will be equal to the lesser of (i) the net purchase price paid to Emergent by the Program Participant for the doses of VIVOTIF described in the Program Administration Form and (ii) the purchase price established by Emergent for VIVOTIF purchases by the Program Participant and in effect as of the date of the credit request. Such credit will apply solely to future purchases of VIVOTIF or other products from Emergent. In the event Emergent elects to accept a request and provide replacement product, it will deliver the replacement product to the Program Participant (at Emergent’s cost and expense).
Recordkeeping:
Each Program Participant will be obligated to maintain accurate books and records supporting any credit or product replacement request made under the Program for a period of five years following the later of (i) the date of the last request submitted hereunder by such Program Participant and (ii) the termination date of the Program. Emergent or its agent may, during normal working hours and with reasonable advance notice, inspect, audit and reproduce such books and records (x) to validate any request made hereunder and/or any representation made on any Program Administration Form by such Program Participant, or (y) as otherwise requested by governmental authorities or required by applicable law or regulation.
Warranty and Disclaimer:
TO THE MAXIMUM EXTEND PERMITTED BY LAW, EMERGENT PROVIDES THE PROGRAM “AS IS” WITH NO WARRANTIES OF ANY KIND AND EXPRESSLY DISCLAIMS ANY WARRANTY, EXPRESS OR IMPLIED, REGARDING THE PROGRAM, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.
Limitation of Liability:
UNDER NO CIRCUMSTANCES WILL EMERGENT OR ITS AFFILIATES OR THEIR RESPECTIVE SHAREHOLDERS, AGENTS, EMPLOYEES, MANAGERS, OFFICERS OR DIRECTORS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES ARISING OUT OF OR IN CONNECTION WITH PARTICIPATION IN THE PROGRAM, WHETHER OR NOT Emergent HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
Sole Remedy:
Any Program Participant who is dissatisfied with the Program or these Terms and Conditions will have as the sole and exclusive remedy the discontinuation of participation in the Program.
Indemnification:
Each Program Participant agrees to indemnify, defend and hold harmless Emergent and its affiliates and their respective shareholders, agents, employees, managers, officers and directors from and against any and all claims, actions, causes of action, liabilities, losses and expenses (including reasonable attorneys’ fees) arising from (i) the Program Participant’s participation in the Program, (ii) the Program Participant’s violation of these Terms and Conditions and (iii) any violation or failure by the Program Participant to comply with all applicable laws and regulations relating to the Program.
Termination:
Emergent reserves the right to terminate or suspend the Program or to remove a Program Participant from the Program, in each case for any reason without notice in its sole discretion. No requests for credit or product replacement will be accepted after termination of the Program or removal of a Program Participant from the Program, regardless of whether the applicable VIVOTIF purchase or request was made prior to such termination or removal.
Amendments:
Emergent reserves the right to amend these Terms and Conditions at any time in its sole discretion.
Governing Law:
These Terms and Conditions will be governed by the laws of the State of Delaware without regard to conflicts of laws principles. Any dispute arising hereunder will be subject to final and binding arbitration in San Mateo County, California before the American Arbitration Association under its then applicable rules for commercial disputes. Each Program Participant and Emergent waive any rights to have any dispute resolved in a court of law by a judge or jury.
Interpretation:
Emergent has the sole authority to interpret these Terms and Conditions and to determine eligibility for participation in the Program and compliance with these Terms and Conditions.
Program Assistance:
For questions or additional information regarding the Program, please visit the Product Replacement Program section of our site or contact Emergent Customer Care at 1-800-533-5899.
This site is intended for U.S. healthcare professionals only.
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