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VIVOTIF for your travelers

Why VIVOTIF?1

VIVOTIF (capsules) 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 (eg, household
contact) to an S. Typhi carrier

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.

The 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 Recommendation

Established Efficacy1

The efficacy of VIVOTIF was evaluated in a randomized, double-blind, controlled field trial performed in Santiago, Chile. Results indicate that adults and children older than 6 years of age may be protected against typhoid fever following the oral ingestion of 4 doses of VIVOTIF.

4-Dose Incidence Study: 2-, 3-, or 4-Dose Schedule1,3

Objective & vaccine schedule

Evaluated the relative efficacy of 2, 3, or 4 doses of VIVOTIF administered on alternate days in 189,819 school-aged children

Results

  • After comparing disease incidence within the 3 groups, relative vaccine efficacy was highest among the 4-dose group
Dosing regimen Incidence per 105 subjects (95% CI)
2-dose 184.6 (152-271)
3-dose 160.5 (130-191)
4-dose 95.8 (71-121)
P<0.002 vs 3-dose
After comparing disease incidence within the 3 groups, relative vaccine efficacy was highest among the 4-dose group

The complete immunization schedule for VIVOTIF consists of 4 capsules with one capsule taken on alternate days (eg, days 1, 3, 5, and 7).

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 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 US citizens, efficacy studies are not currently 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

Safety Profile1

More than 1.4 million doses of Ty21a have been administered in controlled clinical trials
More than 150 million doses have been marketed worldwide of the oral typhoid vaccine

Adverse reactions

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.

Overall symptom rates from 2 studies in persons vaccinated with VIVOTIF

Adverse reactions

%

Abdominal pain
6.4
Nauseaa
5.8
Headache
4.8
Fever
3.3
Diarrhea
2.9
Vomiting
1.5
Rash
1.0

aNausea was the only adverse reaction that occurred at a statistically higher frequency in the vaccinated group compared with the placebo group.

Postmarketing surveillance

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 considered to be an allergic reaction to the vaccine was reported.

Dosing and Administration1

Dosage and administration instructions should be explained carefully to help patients stay on course with VIVOTIF.

One capsule taken on days 1, 3, 5, and 7 may provide up to 5 years of protection against typhoid fever.

Vivotif® dosing and administration Vivotif® dosing and administration

A complete immunization schedule is the ingestion of 4 vaccine capsules as described above.

Do’s and Don’ts of Taking VIVOTIF1

In order 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
  • Keep the capsules refrigerated (35.6°F-46.6°F)
  • The vaccine capsule should be swallowed approximately 1 hour before a meal with cold or lukewarm [temperature not to exceed body temperature, eg, 98.6°F] drink
  • Inspect the blister containing the vaccine capsules to ensure that the foil seal and capsules are intact
  • Swallow the vaccine capsule as soon after placing in the mouth as possible

DON'T

dont-1

DON’T take with
sulfonamides and antibiotics

dont-2

DON’T open or
chew capsules

dont-3

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. Please refer to the CDC Morbidity and Mortality Weekly Report for additional information on concomitant use.

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For medical inquiries about administering VIVOTIF, please contact Medical Information at (800) 533-5899.

How Supplied/Storage and Handling1

Vivotif® supplied, storage and handling

VIVOTIF is supplied in a single foil blister containing 4 doses of vaccine in a single package.

Storage and handling

  • VIVOTIF is not stable when exposed to ambient temperatures, so VIVOTIF should be shipped and stored 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
  • VIVOTIF must be refrigerated between 35.6°F-46.6°F to maintain optimal potency
refernce-img

For medical inquiries regarding temperature deviations by patients, please contact Medical Information at
(800) 533-5899.

View additional Videos & Resources for more information about VIVOTIF, patient support options, and product replacement instructions.

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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.

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.

VIV FULL HCP ISI 11/2019

Please see full Prescribing Information.

References:

  1. VIVOTIF [package insert]. Redwood City, CA: PaxVax, Inc.; 2017.
  2. Typhoid vaccine: what you need to know. Centers for Disease Control and Prevention. Published October 30, 2019. Accessed April 3, 2020. https://www.cdc.gov/vaccines/hcp/vis/vis-statements/typhoid.pdf
  3. Ferreccio C, Levine MM, Rodriguez H, Contreras R. Comparative efficacy of two, three, or four doses of Ty21a live oral typhoid vaccine in enteric-coated capsules: a field trial in an endemic area. J Infect Dis. 1989;159(4):766-769.

Contraindications: VIVOTIF is contraindicated in patients with a hypersensitivity to any component of the vaccine or the enteric-coated capsule.

More

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.

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