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Use and Important Safety Information for VAXCHORA® (vaks-CORE-ah). It is also known as Cholera Vaccine, Live, Oral.

What is VAXCHORA used for?

VAXCHORA is a prescription vaccine used in children at least 2 years old and adults up to 64 years old for a disease called cholera. If you are traveling to areas affected by cholera, you can take VAXCHORA by mouth to help protect you against the type of cholera caused by the bacteria Vibrio cholerae serogroup O1. VAXCHORA has not been shown to work for: People who live in places where there is cholera; People who are protected because they were already exposed to the bacteria the vaccine targets or have had a cholera vaccine; Cholera caused by bacteria not covered by the vaccine

Who should not take VAXCHORA?

Do not use VAXCHORA if you have had a serious allergic reaction to any ingredient of VAXCHORA or to a previous dose of any cholera vaccine.

Can I take VAXCHORA if I have a weakened immune system?

VAXCHORA was not studied in people with a weakened immune system. The vaccine may not protect these people.

It is important to tell your healthcare provider (HCP) if:

• You have any medical condition that may lower your ability to fight infections
• You are taking any medications that may lower your ability to fight infections
• You have a weakened immune system

If I take VAXCHORA, could I put close contacts at risk if they have weakened immune systems?

• It is important to tell your HCP if you are in close contact with anyone that has a weakened immune system
• For at least a week after you take the vaccine, it is possible to spread the bacteria in the cholera vaccine while using the bathroom
• For at least 14 days following vaccination with VAXCHORA, you should wash your hands thoroughly after using the bathroom and before preparing or handling food

What are the most common side effects of VAXCHORA?

In clinical trials of adults (18–45 years old), the most common side effects were tiredness, headache, stomach pain, nausea, vomiting, loss of appetite, and diarrhea. In children and adolescents (2–17 years old), the most common side effects were headache, tiredness, stomach pain, loss of appetite, and nausea.

These are not all the possible side effects of VAXCHORA. 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.

Can I take VAXCHORA if I take other medications?

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

Certain treatments, like antibiotics, some anti-malaria medications, and therapies that can weaken the immune system, can interfere with how VAXCHORA works. As needed, your doctor can discuss with you whether to postpone or decide against taking VAXCHORA.

If I am vaccinated with VAXCHORA, will I be fully protected and able to relax about what I eat and drink in cholera-affected areas where I am traveling?

Vaccination with VAXCHORA does not eliminate the need for you to be careful about the food and water you consume in cholera-affected areas. Food and water that have been contaminated with fecal matter from people who are infected with cholera bacteria is the biggest source of risk for a traveler.

Learn more

This summary provides basic information about VAXCHORA 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 VAXCHORA is right for you.

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