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.
