Product VIVOTIF

What is VIVOTIF1?

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.

Established Efficacy from Clinical Trials1

The efficacy of VIVOTIF was evaluated in randomized, double-blind, controlled field trials performed in Santiago, Chile. Results from clinical studies 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.

Trial 1

1- and 2-Dose Schedule 2

Objective

Compared the efficacy of VIVOTIF in 82,543 school-aged children

Vaccine Schedule

1 or 2 doses of vaccine were given 1 week apart

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Results

Dose Schedule Vaccine Efficacy (95% CI)
Single Dose 29% (4%-47%)
Two Doses 59% (41%-71%)

3-Dose Schedule 2

Objective

Evaluated the efficacy of VIVOTIF in
109,594 school-aged children

Vaccine Schedule

3 doses of VIVOTIF were administered either on alternate days (short immunization schedule) or
21 days apart (long immunization schedule)

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Results

Vaccine efficacy was evaluated 3, 4, and 5 years postvaccination

Administration of VIVOTIF Alternate days 21 days apart
Vaccine Efficacy (95% CI)
36 months 67% (47%-79%) 49% (24%-66%)
48 months 69% (55%-80%) --
60 months Undiminished level of protection

The complete immunization schedule for VIVOTIF consists of 4 capsules with one capsule taken on Days 1, 3, 5, and 7.

2-, 3-, or 4-Dose Schedule 2

Objective & Vaccine Schedule

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

Results

  • After comparing disease incidence within the 3 groups, relative vaccine efficacy was highest among 4-dose group

  • The incidence of typhoid fever per 105 study subjects was 160.5 (95% CI, 130-191) for the 3-dose regimen versus 95.8 (95% CI, 71-121) for the 4-dose regimen (p<0.004)

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Dosing regimen Incidence per 105 subjects (95% CI)
3-dose 160.5 (130-191)
4-dose 95.8 (71-121)

The complete immunization schedule for VIVOTIF consists of 4 capsules with one capsule taken on Days 1, 3, 5, and 7.

Immune Response1

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.

  • Studies comparing levels of anti-S. Typhi antibodies between adults living in endemic areas (Chile) and nonendemic areas (United States and Switzerland) show 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 Efficacy1

  • Efficacy of VIVOTIF has been shown to persist for at least 5 years.
  • It is recommended that re-immunization 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

VIVOTIF dosage

Adverse Reactions1

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 capsules
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 Surveillance1

Adverse reactions reported during 1991–1995, during which time over 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, non-fatal anaphylactic shock 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.

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

Dosing

DO'S AND DON'TS OF TAKING VIVOTIF

DO

  • Complete the course of VIVOTIF at least 1 week before leaving for a trip
  • 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 luke-warm [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

Don't take

Administering oral polio or yellow fever vaccines at the same time as VIVOTIF does not suppress the immune response triggered by VIVOTIF1. 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 (888) 483-9053.

How Supplied/Storage and Handling

VIVOTIF

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. VIVOTIF should be shipped and stored between 2°C and 8°C (35.6°F and 46.4°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 and 46.4°F (the typical temperature of a refrigerator) to maintain optimal potency.

For medical inquiries regarding temperature deviations by patients, please contact Medical Information at (888) 483-9053.

Resources for Your Patients

Patient Text Reminder Program

Help your patients stay on course with VIVOTIF by encouraging them to sign up for text message reminders. They will receive text message reminders over the course of 7 days when it’s time to take their capsules.

Product Replacement Program

Emergent will supply replacement doses of VIVOTIF for patients who qualify. View details or request a replacement product.

Indication and 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

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. 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.

Reference:

  • VIVOTIF (Typhoid Vaccine Live Oral Ty21a) [package insert]. Redwood City, CA: PaxVax Inc., 2017.

Indication and 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.

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