Vivotif® Oral Typhoid Vaccine Clinical Trials, Dosage, Side Effects
Bavarian Nordic's Vivotif® (Typhoid Vaccine Live Oral Ty21a) is the only oral vaccine licensed by the U.S. Food and Drug Administration (FDA) (Updated September 2013, Package Insert September 2020.) to prevent typhoid fever, a potentially severe and life-threatening infection caused by the bacterium Salmonella typhi. Vivotif is a live attenuated vaccine indicated for the immunization of adults and children over six years of age and does not cause typhoid fever.
Vivotif Oral works by causing the body to produce antibodies that protect against the bacteria (germs) that cause typhoid fever. The antibodies destroy the Salmonella typhi bacteria. However, Vivotif does not afford protection against Salmonella species other than Salmonella typhii or other bacteria that cause enteric disease.
Emergent BioSolutions Inc. sold this travel vaccine to Bavarian Nordic A/S on May 15, 2023.
Vivotif Availability 2025
As of March 2025, the vaccine is marketed in the U.S. and Europe under Vivotif® and in Germany under the name Typhoral® L. This vaccine focuses primarily on the U.S. market, accounting for around 60% of the product's total revenue in 2024.
Vivotif Indication
Vivotif is an oral vaccine that prevents typhoid fever, a potentially severe and life-threatening infection caused by the bacterium Salmonella Typhi (S Typhi). Vivotif (capsules) is available for adults and children six years and older. 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 Salmonella species other than Salmonella Typhi or other bacteria that cause enteric disease. The vaccine is not suitable for treating acute infections with S. Typhi. According to the U.S. CDC, there is no evidence to support the use of typhoid vaccines to control common source outbreaks, diseases following natural disasters, or persons attending rural summer camps.
Routine typhoid vaccination is not recommended in the USA. However, 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 frequently work with S. Typhi. Vivotif is not to be taken during an acute gastrointestinal illness. Postpone taking the vaccine if persistent diarrhea or vomiting occurs.
Vivotif Dosage
The immunization schedule for Vivotif Oral consists of four capsules, one taken on alternate days (days 1, 3, 5, and 7). The vaccine is administered orally to the mucosal surface of the gastrointestinal tract, the largest immunologic organ in the body. The efficacy of Vivotif has been shown to persist for at least five years; therefore, it is recommended that reimmunization be given every five years under conditions of repeated or continued exposure to typhoid fever.
Vivotif must be refrigerated between 35.6°F-46.6°F to maintain optimal potency.
Typhoid Outbreaks
Typhoid fever, caused by the bacterium Salmonella enterica serovar Typhi (S. Typhi), remains a significant public health challenge in many parts of the world. This research article, published in 2025, contributes to infectious disease modeling and offers a valuable resource for enhancing typhoid fever control measures globally.
Vivotif News
March 20, 2025 - Three typhoid-related deaths have been reported in Negros Occidental province, Philippines.
May 15, 2023 - Emergent BioSolutions completed the sale of its travel health business to Bavarian Nordic.
July 28, 2022 - New antibiotic-resistant typhoid strains are rising, fueling outbreaks worldwide and making up a more significant percentage of the yearly toll of 10 to 20 million cases and 100,000 deaths.
May 1, 2022 - The Lancet published: Estimating the effect of vaccination on antimicrobial-resistant typhoid fever in 73 countries supported by Gavi: a mathematical modeling study. Interpretation - Our results indicate the benefits of prioritizing TCV introduction for countries with a high avertable burden of antimicrobial-resistant typhoid fever.
March 1, 2021 - The U.S. CDC reissued a Level 1 Travel Alert stating, 'There is an ongoing outbreak of extensively drug-resistant (XDR) typhoid fever in Pakistan. XDR typhoid infections in people with a history of travel to Pakistan have been reported in North America, Europe, and Australia; therefore, the CDC recommends that all travelers (even short-term travelers) to South Asia, including Pakistan, be vaccinated against typhoid fever before travel.'
February 12, 202:- The U.S. CDC Health Alert Network issued 'Extensively Drug-Resistant Salmonella Typhi Infections Among U.S. Residents Without International Travel.' As of January 14, 2021, the CDC has received 71 reports of XDR Typhi infection in the United States, with specimens obtained from February 9, 2018, through November 16, 2020. Among 67 patients with known travel history, 58 (87%) had traveled to Pakistan 30 days before the illness began.
August 13, 2018 - Emergent BioSolutions acquired PaxVax and two travel vaccines in a $270M deal. Vivotif, which PaxVax acquired in 2014, is one of two typhoid vaccines available in the USA.
Vivotif Oral Vaccine Clinical Trial
Clinical Trial: NCT0370558 is an open-label, non-randomized phase 4 study. It aims to understand how vaccines against typhoid fever and cholera affect the intestine's normal immune system. Patients with standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into three groups. The Last Update was Posted on October 16, 2019.