Consumer & Patient Information | Vivotif® Oral Typhoid Vaccine

VIVOTIF may help provide protection against typhoid fever for at least 5 years.¹

Vivotif® can help provide protection against typhoid fever for up to 5 years

Not all recipients of VIVOTIF will be fully protected against typhoid fever¹
Vaccinated individuals should continue to take personal precautions to avoid contact or ingestion of potentially contaminated food or water¹
The optimum booster schedule for VIVOTIF has not been determined¹
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 fever¹

Sampling local cuisine can be one of the most enjoyable parts of traveling; however, when it comes to food and drink, you should understand the risk that typhoid fever can present.

Typhoid fever is a potentially severe and life-threatening illness caused by a type of bacteria called Salmonella typhi.² It’s spread by contaminated food and water.² Common symptoms of typhoid fever include loss of appetite, headache, weakness, stomach pain, and constipation or diarrhea.^3,4 In severe cases, stomach bleeding, brain damage, and death may occur.⁴

Typhoid fever is commonly found in regions of the world where water and food may be unsafe, including parts of South Asia, Africa, Latin America, Southeast Asia, East Asia, and the Caribbean.^4,5

Typhoid fever is commonly found in many regions of the world, including parts of East and Southeast Asia, the Caribbean, Africa, and Central and South America

Take precautions even after vaccination because the vaccine does not completely protect against typhoid fever. While traveling, follow good hygiene practices and ensure the food and water you consume is as safe as possible.¹

It’s also important to know that the danger from typhoid fever doesn’t end when symptoms disappear.³ Even when symptoms seem to go away, you may still be carrying Salmonella Typhi and can pass it on to someone else.³

VIVOTIF is the only FDA-approved oral vaccine for typhoid fever.^1,4

VIVOTIF is a prescription vaccine you take by mouth to help protect you from typhoid fever.¹ VIVOTIF is for adults and children greater than 6 years of age.¹

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 where 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.

While typhoid fever can be treated with antibiotics, according to data reported in 2017, 74% of Salmonella Typhi infections are resistant to one of the most commonly used antibiotics.⁶

VIVOTIF can help provide protection
when the full course is taken at least 1 week prior to traveling.¹

VIVOTIF is an oral vaccine.¹

How to take VIVOTIF¹:

One complete dosing schedule consists of 4 capsules
VIVOTIF is taken every other day for 7 days
(see illustration below)

GET TEXT REMINDERS

To enroll in the TAKE 4 text reminder program, text "TRAVEL" to 1-833-207-3377 on the day of your first dose. You will receive a text every other day reminding you to take your next dose and to refrigerate the remaining capsules.*

*The information requested will be used by Bavarian Nordic to send you information related to vaccines and travel health. Message and data rates may apply. This is a recurring program that includes a number of messages over the course of 7 days. At any time during the program, patients may text "HELP" for assistance or "STOP" to discontinue receiving messages.

All 4 doses of VIVOTIF should be taken at least 1 week before traveling.¹

Swallow one capsule about 1 hour before a meal with a cold or lukewarm (temperature not to exceed body temperature, e.g., 37°C [98.6°F]) drink.¹ It doesn’t matter what time you take your capsule, as long it’s at least 1 hour before a meal¹:

Swallow the capsule as soon after placing in the mouth as possible. Don't open or chew capsule
Do not freeze the capsules. Keep capsules refrigerated (35.6ºF–46.4ºF) until you're ready to take them

GET TEXT REMINDERS

ASK HOW VIVOTIF MAY HELP PROTECT YOU WHILE TRAVELING
TO TYPHOID FEVER–AFFECTED AREAS.

Find a Travel Healthcare
Provider near you

Use and Important Safety Information for VIVOTIF^® (vee-voh-TEEF). It is also known as Typhoid Vaccine, Live, Oral Ty21a.

What is VIVOTIF used for?

VIVOTIF is a prescription vaccine you take by mouth to help protect you from typhoid fever. Typhoid fever, which can be a life-threatening disease, is caused by a specific type of bacteria. VIVOTIF is for adults and children more than 6 years of age.

Immunization with VIVOTIF is not routinely recommended for people living in the United States; however, VIVOTIF is recommended for people who are at a higher risk of getting typhoid fever. This includes:

People who travel to places where typhoid fever is more common
People who have close contact with someone who has had typhoid fever or is known to be carrying the bacteria that causes it
People who work in laboratories who could have contact with the bacteria that causes typhoid fever (Salmonella typhi)

VIVOTIF has not been shown to protect against typhoid fever in common source outbreaks, following natural disasters, or in people attending rural summer camps.

Not all people will be fully protected from typhoid fever following vaccination. While you travel to areas where typhoid fever is common, you should take care to ensure the food you eat and water you drink are safe.

VIVOTIF will not protect you from other kinds of Salmonella bacteria besides S. typhi and will not treat typhoid fever if you have been infected.

Who should not take VIVOTIF?

Do not use VIVOTIF if you are allergic to any of the ingredients in the vaccine or the enteric-coated capsule.

Do not take VIVOTIF if you have an active fever or if your immune system is weakened, including as a result of a disease or other medicines you take.

Can I take VIVOTIF if I have a stomach or intestinal illness?

If you have a sudden stomach or intestinal illness, postpone taking VIVOTIF and tell your healthcare provider (HCP).

Can I take VIVOTIF if I have ongoing diarrhea or vomiting?

If you are vomiting or have diarrhea that will not stop, do not take VIVOTIF until the vomiting and diarrhea have stopped.

Can I take VIVOTIF if I take other medications?

Tell your HCP about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take.

Certain treatments, like antibiotics and some anti-malaria medications, can interfere with how VIVOTIF works. As needed, your doctor can discuss with you whether to postpone or decide against taking the vaccine.

How should I take and store the 4 doses of VIVOTIF to get the full protective effect?

It is essential that you take all 4 doses of VIVOTIF, every other day until you complete the series, to ensure that you get the full protective effect of the vaccine. Do not chew the capsule and swallow the capsule as soon as possible once you put it in your mouth. It is also essential to replace unused vaccine in the refrigerator between doses

Can I take VIVOTIF if I am pregnant or nursing?

If you are pregnant, you should take VIVOTIF only if clearly needed because it is not known whether VIVOTIF can cause harm to a developing baby or interfere with a healthy birth. Also, no evidence exists to show that VIVOTIF is safe and effective in nursing mothers, and it is not known if VIVOTIF gets into breast milk.

What are the most common side effects of VIVOTIF?

In clinical trials of people receiving 3 doses of VIVOTIF, the most common side effects were abdominal pain, nausea, headache, fever, diarrhea, vomiting, and skin rash. Only nausea was more common in people that took VIVOTIF compared with those who took a sugar pill.

These are not all the possible side effects of VIVOTIF. Patients should always ask their healthcare professionals for medical advice about the appropriate use of vaccines and adverse events. 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.

Learn More

This summary provides basic information about VIVOTIF, but it does not include all information known about this vaccine. Talk to your HCP or pharmacist about this information. Your HCP is the best person to help you decide if VIVOTIF is right for you.

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

CDC, Centers for Disease Control and Prevention; FDA, U.S. Food and Drug Administration.

References

VIVOTIF (Typhoid Vaccine Live Oral Ty21a) [package insert]. Redwood City, CA: Emergent Travel Health Inc.
Centers for Disease Control and Prevention. Typhoid fever and paratyphoid fever. Questions and answers. Last reviewed November 16, 2020. Accessed January 5, 2024. https://www.cdc.gov/typhoid-fever/sources.html
Centers for Disease Control and Prevention. Typhoid fever and paratyphoid fever. Symptoms and treatment. Last reviewed December 12, 2022. Accessed January 5, 2024. https://www.cdc.gov/typhoid-fever/symptoms.html
CDC Yellow Book 2024: Typhoid & paratyphoid fever. Updated May 1, 2023. Accessed January 5, 2024. https://wwwnc.cdc.gov/travel/yellowbook/2024/infections-diseases/typhoid-and-paratyphoid-fever
Centers for Disease Control and Prevention. Typhoid fever and paratyphoid fever. Prevention tips for travelers. Last reviewed May 19, 2020. Accessed January 5, 2024. https://www.cdc.gov/typhoid-fever/prevention.html
Centers for Disease Control and Prevention. Drug-resistant salmonella serotype typhi. Accessed January 5, 2024. https://www.cdc.gov/drugresistance/pdf/threats-report/salmonella-typhi-508.pdf

US-VIV-2300009 | March 2024

Allow	Category	Purpose	Tools
Yes No	Functional	To monitor the performance of our site and to enhance your browsing experience. For example, these tools enable you to communicate with us via live chat.
Yes No	Marketing and Analytics	To understand user behavior in order to provide you with a more relevant browsing experience or personalize the content on our site. For example, we collect information about which pages you visit to help us present more relevant information.	Google Analytics
Yes No	Advertising	To personalize and measure the effectiveness of advertising on our site and other websites. For example, we may serve you a personalized ad based on the pages you visit on our site.	Facebook Pixel, Google Tag Manager
N/A	Essential	We use browser cookies that are necessary for the site to work as intended. For example, we store your website data collection preferences so we can honor them if you return to our site. You can disable these cookies in your browser settings but if you do the site may not work as intended.

FIND A TRAVEL HEALTHCARE PROVIDER

Before you depart for your trip, help protect yourself against typhoid fever

VIVOTIF may help provide protection against typhoid fever for at least 5 years.¹

Typhoid fever is commonly found in regions of the world where water and food may be unsafe, including parts of South Asia, Africa, Latin America, Southeast Asia, East Asia, and the Caribbean.^4,5

Take precautions even after vaccination because the vaccine does not completely protect against typhoid fever. While traveling, follow good hygiene practices and ensure the food and water you consume is as safe as possible.¹