Vivotif® Oral Typhoid Vaccine 2023
Bavarian Nordic's Vivotif® (Typhoid Vaccine Live Oral Ty21a) is the only oral vaccine licensed by the U.S. Food and Drug Administration (FDA) 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 its protection against the bacteria (germs) that cause typhoid fever. The body makes antibodies, which destroy the Salmonella typhi bacteria. Vivotif will not afford protection against Salmonella species other than Salmonella Typhi or other bacteria that cause enteric disease.
Vivotif Package Insert USA – Final September 2020.
Emergent BioSolutions Inc. sold this vaccine to Bavarian Nordic A/S on February 15, 2023.
As of May 20, 2019, Emergent BioSolutions Announces the granting of Marketing Authorization in five EU Countries for Its Oral Typhoid Vaccine. In the U.S. and Europe, the vaccine is marketed under Vivotif®, and in Germany under the name Typhoral® L.
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. There is no evidence to support typhoid vaccine use to control common source outbreaks, disease following natural disasters, or in persons attending rural summer camps, says the U.S. CDC.
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.
The immunization schedule for Vivotif Oral consists of 4 capsules, with one capsule taken on alternate days (days 1, 3, 5, and 7). Taken orally, the vaccine is delivered 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 5 years. It is recommended that reimmunization be given every 5 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, says the U.S. FDA.
July 28, 2022 - New antibiotic-resistant typhoid strains are on the rise, fueling outbreaks across the world and making up a greater 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. The CDC recommends that all travelers (even short-term travelers) to South Asia, including Pakistan, be vaccinated against typhoid fever before travel.'
February 12, 2021 - 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 in the 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: NCT03705585 - This is an open-label, non-randomized phase 4 study. This study intends to understand how vaccines against typhoid fever and cholera affect the intestine's normal immune system and bacteria. Patients having standard-of-care endoscopies (colonoscopy and/or esophagogastroduodenoscopy (EGD)) will be divided into 3 groups. Last Update Posted: October 16, 2019.