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Vaxchora® Cholera Vaccine (CVD 103-HgR) Clinical Trials, Dosage, Indication, Side Effects

Bavarian Nordic Vaxchora® (CVD 103-HgR) is a live attenuated recombinant V. cholerae O1 Inaba Vaccine Strain CVD 103-HgR, which can synthesize the immunogenic nontoxic B subunit of CT (encoded by the ctxB gene). Vaxchora is a single-dose oral cholera vaccine (OCV) for active immunization against disease caused by Vibrio cholerae serogroup O1. Vaxchora contains a weakened form of the cholera bacterium serogroup O1. The V. cholerae vaccine strain produces an incomplete, nontoxic form of the cholera toxin, which replicates in the gastrointestinal tract. Vaxchora is made in water and administered orally as a single dose at least 10 days before the person is likely to contract cholera.

Vaxchora is the only U.S. FDA-approved vaccine (2016) to prevent cholera: STN: 125597. It was approved on December 23, 2020, by BL 125597/123 for people ages 2 through 64 traveling to cholera-affected areas. The European Medicines Agency (EMA) noted that evidence from Vaxchora studies is relevant only for travelers visiting areas where cholera is present. The EMA authorized Emergent Netherlands B.V. for Vaxchora in January 2020: EMEA/H/C/003876. 

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) published its recommendations for the use of the lyophilized CVD 103-HgR vaccine (Vaxchora) on September 30, 2022. On January 12, 2022, the U.S. CDC's vaccine committee reviewed the following presentations:  Introduction to the Cholera Vaccine Session, Pablo Sanchez, MD; Vaxchora Vaccine - Pediatric Dose Development, James McCarty, MD; Evidence to Recommendations: CVD 103-HgR among children and adolescents aged 2–17 years, Jennifer P. Collins, MD, MSc. Then, on February 23, 2022, Jennifer P. Collins, MD, MSc, CDC Lead, Cholera Vaccine Work Group, presented 'Evidence to recommendations summary, considerations for use, and proposed policy option: CVD 103-HgR among children and adolescents aged 2–17 years.' The CDC confirmed eight cholera cases in the U.S. related to travelers on December 5, 2022.

Bavarian Nordic is a fully integrated vaccine company with a mission to protect and save lives through innovative vaccines. Vaxchora revenue decreased by 55% in the first nine months of 2025, primarily because a cholera outbreak in 2024 on the French island of Mayotte positively impacted 2024 sales on the island, and also due to low market demand in the U.S.

For more information, visit www.bavarian-nordic.com.

Vaxchora Indication

Vaxchora is indicated for active immunization against disease caused by Vibrio cholerae serogroup O1 in adults 18 through 64 years of age traveling to an active cholera-affected area. Active transmission is defined as having cases reported within the past year. The CDC Advisory Committee on Immunization Practices recommends Vaxchora for adult travelers aged 18 to 64 who visit an area of active cholera transmission. Active transmission is defined as having cases reported within the past year.

Cholera, an acute bacterial disease of the small intestine, causes severe vomiting, diarrhea, and dehydration that can become life-threatening. It is estimated that three million to five million cholera cases occur yearly, causing nearly 100,000 fatalities worldwide. However, most people infected with V. cholerae do not experience symptoms.

Vaxchora Vaccine Dosage

Vaxchora (CVD 103-HgR) is a live, weakened, single-dose, oral liquid vaccine containing approximately three fluid ounces. It should be administered at least ten days before travel to a cholera-affected area.

Vaxchora Vaccine Availability

Since January 2025, the International Coordinating Group on Vaccine Provision received 38 requests from 12 countries, triple the number compared to the same period in 2024. As of September 2025, over 40 million doses have been allocated, compared to 35 million doses allocated in all of 2024. As of August 2025, Vachora is approved in Australia, the United Kingdom, the European Union, and the United States. It is the only single-dose cholera vaccine approved in Canada and the only FDA-approved vaccine available in the United States. The initial U.S. FDA approval was in 2016.

On May 9, 2025, the Company reported that Vaxchora revenue was DKK 9 million (DKK 11 million) in the first quarter of 2025.

Gaithersburg, Maryland-based Emergent BioSolutions sold the vaccine to Bavarian Nordic A/S (BVNRY) on May 15, 2023, and is relaunching it in key U.S. and European markets as of March 2025.

Vaxchora Limitations of Use

The effectiveness of Vaxchora (CVD 103-HgR) has not been established in persons with pre-existing immunity due to previous exposure to V. cholerae or the receipt of a cholera vaccine. The safety and effectiveness of Vaxchora in pregnant or breastfeeding women are not yet known, and it is unknown how long protection lasts beyond 3 – 6 months after getting the vaccine. Side effects from Vaxchora are uncommon and may include tiredness, headache, abdominal pain, nausea and vomiting, lack of appetite, and diarrhea. Vaxchora has not been shown to protect against disease caused by V. cholerae serogroup O139 or other non-O1 serogroups.

Store Vaxchora buffer component and active component packets refrigerated at 36°F to 46°F (2°C to 8°C). Packets should not be out of refrigerated storage for more than 15 minutes before reconstitution; when out of refrigerated storage, packets should not be exposed to temperatures above 80°F (27°C)

Vaxchora Pregnancy Registry

Vaxchora (Cholera Vaccine, Live, Oral) Pregnancy Registry has been established to monitor the safety of Vaxchora use during pregnancy. Vaxchora is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Studies have not been performed among pregnant women who have taken Vaxchora. The pregnancy registry aims to prospectively collect data on the safety of VAXCHORA exposure on pregnant women and their offspring. The registry is strictly observational.

Cholera Outbreaks

As of 2025, various cholera outbreaks have been reported this year.

Vaxchora Vaccine News

September 16, 2024 - "Canadians are passionate about exploring. To help them prevent illness while traveling internationally, we are expanding our vaccine offerings to include protection against cholera. Healthcare providers can now offer this new vaccine option to travelers who plan to visit countries where cholera is present," said Karinne Lacombe, Canada Country Director, Bavarian Nordic.

May 15, 2023 - Emergent BioSolutions announced it had completed the sale of its travel health business to Bavarian Nordic.

October 19, 2022 - A strained global supply of cholera vaccines has obliged the International Coordinating Group to temporarily suspend the standard two-dose vaccination regimen in cholera outbreak response campaigns and use a single-dose approach.

July 5, 2022 - A study published in Nature Communications shows how O139 V. cholerae disappeared. However, it caused several outbreaks in India and Bangladesh in the early 1990s and temporarily displaced O1 V. cholerae as the dominant, disease-causing variant.

June 13, 2022: Undersecretary-General and Emergency Relief Coordinator Martin Griffiths approved the allocation of US$1.7 million from the Central Emergency Response Fund to support the urgent response to the cholera outbreak in Cameroon.

May 23, 202The 2 - The Malawi Ministry of Health launched a national Oral Cholera Vaccination campaign targeting over 1.9 million people (over one year of age) living in cholera hot-spot districts in the southern region.

April 29, 2022 - Vaccination contributed to the fight against the cholera epidemic that affected seven regions of Niger, causing 5591 infections and 166 deaths, with a case-fatality rate of 3%. Vaccination coverage of 95%, combined with good patient management, hygiene, and sanitation awareness, led to a significant decrease in the number of new cases until the epidemic was declared over in the following weeks.

February 23, 2022 - Pablo Sanchez, MD, Chair, CDC Cholera Vaccine Work Group, presented Introduction to the Cholera Vaccine Session.

January 12, 2022 - The U.S. CDC's ACIP meeting Cholera Presentation Slides were posted online.

January 31, 2020 - EU Panel Backs Cholera Vaccine Vaxchora for Adults, Children. The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended marketing authorization for a cholera vaccine (recombinant, live, oral) (Vaxchora, Emergent Netherlands B.V.) for protection against cholera in adults and children, according to an EMA summary of the opinion.

June 10, 2016 - The U.S. Food and Drug Administration approved Vaxchora, a vaccine for preventing cholera caused by serogroup O1 in adults 18 through 64 traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine for the prevention of cholera.

Vaxchora (CVD 103-HgR) Vaccine Cholera Clinical Trials

The Vaxchora vaccine continues to be studied in various clinical trials.

Ervebo® (rVSVΔG-ZEBOV-GP) Ebola Vaccine Clinical Trials, Dosage, Efficacy, Indication, Side Effects

Merck Ervebo® Ebola Vaccine (rVSV-ZEBOV-GP, rVSV-ZEBOV, v920) is a live, recombinant, replication-competent Ebola virus zairense vaccine. Ervebo's active ingredient is Vesicular Stomatitis Virus (VSV), whose surface protein has been replaced with that of Ebola virus disease (EBOV). In addition, the Ervebo vaccine was genetically engineered to express the main glycoprotein from the Zaire ebolavirus, thereby provoking a neutralizing immune response. In November 2019, the World Health Organization (WHO) prequalified Ervebo. The U.S. Food and Drug Administration (FDA) issued STN: BL 125690/0 on December 19, 2019, and STN: BL 125690/55 on July 27, 2023. On August 3, 2023, the FDA approved (STN: 125690) an expanded indication for Ervebo for individuals 12 months and older. In Canada, Ervebo was approved in November 2022. 

Ervebo was granted Conditional Approval by the European Medicines Agency (EMA) for the European Union on November 11, 2019 (EMEA/H/C/004554). On July 20, 2023, the EMA's Committee for Medicinal Products for Human Use recommended the expanded approval of Ervebo for active immunization of individuals one year or older. As of September 7, 2023, Ervebo is indicated by the EMA (EMA/344888/2023) for the prevention of disease caused by Zaire ebolavirus in individuals 12 months of age and older living in Europe.

The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM-CBRN) helped provide a test that enabled Merck Sharp & Dohme B.V. to test human and non-human primate samples. The Ervebo vaccine protects people from Zaire but not against other Ebolavirus (Sudan) or Marburgvirus species. Additionally, it is unlikely that people could become infected with EBOV from the Ervebo vaccine, as it only contains one gene from the Ebola virus, not the entire virus. Specifically, it includes a gene for the EBOV glycoprotein that replaces the gene for the native VSV glycoprotein, says the U.S. Centers for Disease Control and Prevention (CDC). Merck and the U.S. government initially partnered in December 2014 through a third party, BioProtection Systems. In 2017, utilizing Project BioShield Act authority, U.S. BARDA funded work with Merck to continue late-stage development activities and began collaborating to expand ERVEBO's indication to include pediatrics. 

As of May 2024, the U.S. CDC reported that most doses (139,120; 95%) shipped from the ICG stockpile since 2021 have been repurposed for preventive vaccination of high-risk groups, compared with 6,570 (5%) used for outbreak response. The WHO's Annexes to the recommendations for using the Ebola vaccines, providing evidence to support the decision, were published in June 2024. As of April 2025, about 500,000 doses are stored in Switzerland. 

Drugbank's Accession Number: DB15595. ATC code: J07BX02. STN: 125690. Clinical Reviewer: Rebecca Reindel.

New Jersey-based Merck Sharp & Dohme LLC licensed the global R&D and manufacturing rights from Newlink Genetics Corp.'s phase I Ebola vaccine in 2014. The Public Health Agency of Canada, which initially developed the vaccine, retained noncommercial rights in the agreement.

Ervebo Vaccine Efficacy 

The Lancet Infectious Diseases, Volume 24, Issue 12, pp. 1357-1365, December 2024, confirms that rVSV-ZEBOV is highly protective against Zaire Ebolavirus disease and supports its use during outbreaks, even in challenging contexts, such as the eastern Democratic Republic of the Congo. A real-world study published on August 20, 2024, found that rVSV-ZEBOV was 84% effective against infection. On May 9, 2024, a preprint study published by The Lancet concluded that new data add further evidence of rVSV-ZEBOV safety and immunogenicity, including in people with pre-existing antibodies from suspected natural ZEBOV infection, which do not blunt the rVSV-ZEBOV immune response. On February 7, 2024, the Lancet Infectious Diseases published an analysis of all 2,279 patients with confirmed Ebola virus disease. rVSVΔG-ZEBOV-GP vaccination significantly lowered case fatality risk (vaccinated: 25% [106/423] vs not vaccinated: 56% [570/1015]; p<0·0001). A related commentary stated that this study shows that VSV-EBOV's protection extends beyond infection. The CDC evaluated vaccine efficacy in a two-part phase 3, open-label, cluster-randomized, controlled ring vaccination trial in Guinea during the 2014–2016 Ebola outbreak in West Africa. Based on cluster-level data, vaccine efficacy in the follow-up study was estimated at 100% (95% CI: 79.3%–100%).

Ervebo Vaccine Booster Dose

The Lancet Microbe published results from a study on October 4, 2024, which, in marked contrast to earlier trials evaluating short-term boosting, concluded. Delaying a rVSVΔG-ZEBOV-GP booster until month 18 resulted in an increase in GMT that remained several-fold above the GMT of the no-booster group for at least 18 months. These findings could have implications for defining the optimal timing of booster doses as preexposure prevention in populations at ongoing risk for Ebola virus exposure.

Ervebo Vaccine Availability

As of December 2024, the Ervebo vaccine was licensed in the U.S., U.K., European Union, Canada, Switzerland, Burundi, Central African Republic, the Democratic Republic of the Congo, Ghana, Guinea, Rwanda, Uganda, and Zambia. The Ervebo vaccine is not planned for commercial marketing in the U.S. but is maintained in the U.S. Strategic National Stockpile (SNS), with access facilitated by the U.S. government.

Ervebo Ingredients 

The inactive ingredients of this Ebola vaccine include recombinant human serum albumin and tromethamine (Tris) buffer, which contain a trace amount of rice protein.

Ervebo Indication

The Ervebo vaccine is indicated for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. However, the duration of protection conferred by Ervebo is unknown. Additionally, the effectiveness of the vaccine when administered concurrently with antiviral medication, immune globulin, and/or blood or plasma transfusions is unknown. The WHO published the revised Ebola Vaccine FAQ, and the U.S. CDC published Ebola Vaccine: Information for U.S. Healthcare Providers. Merck advises against administering Ervebo to individuals with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including rice protein.

Ervebo Dosage

The Ervebo vaccine is administered as a single-dose intramuscular injection in the top of your arm. Pre-vaccination serological screening is not required.

Ervebo Booster Dose

The U.S. FDA approves initial doses of ERVEBO for the prevention of EVD. Since an Ervebo vaccine booster dose is not an EMA or FDA-approved indication, the U.S. CDC sponsored an expanded access Investigational New Drug program in April 2022. This program allowed booster doses of preexposure prophylaxis for adults who were vaccinated at least 6 months prior and had a potential risk of occupational exposure to EBOV.

Ervebo Side Effects

On December 14, 2022, the NEJM published an Original Article confirming the safety and effectiveness of the ERVEDO vaccine. Do not administer ERVEBO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including rice protein. Among 18,616 participants vaccinated with at least one dose of ERVEBO in clinical trials, 2 reported anaphylaxis. Injection-site side events include injection-site pain and redness.

The most common injection-site adverse events were injection-site pain (70%), swelling (17%), and redness(12%). The most common systemic adverse events reported following vaccination with ERVEBO were headache (37%), feverishness (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and abnormal sweating (3%). 

The safety and effectiveness of ERVEBO, a live virus vaccine, have not been assessed in immunocompromised individuals, and its effectiveness may be diminished in this population. The risk of vaccination with ERVEBO in immunocompromised individuals should be weighed against the risk of disease due to the Zaire ebolavirus.

Inform your healthcare provider promptly about any unusual or severe symptoms that occur after receiving this vaccine. You may also report any side effects to Merck Sharp & Dohme Corp, a Merck & Co., Inc. subsidiary, at 1-877-888-4231 or the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967, or you can report online at www.vaers.hhs.gov.

Ervebo Pregnant Women

Among immediately vaccinated pregnant women, 14 of 31 (45%) experienced pregnancy loss compared with 11 of 33 (33%) unvaccinated pregnant women (unadjusted RR: 1.35; 95% CI: 0.73–2.52). Overall, the pregnancy loss rate among pregnant women who received immediate vaccination was not statistically significantly higher than that among unvaccinated pregnant women. In addition, no external congenital anomalies were detected among live-born infants in either group (n = 44).

Ervebo U.S. CDC - FDA Presentations

The U.S. CDC published an update to the VIS sheet on June 30, 2022. On November 3, 2021, Jason Malenfant, MD, MPH, Epidemic Intelligence Service Officer, Viral Special Pathogens Branch, CDC, presented 'Evidence for Expansion of Recommendations for PreExposure Vaccination with rVSVΔG-ZEBOV-GP Ebola Vaccine for Special Pathogens Treatment Centers and Laboratory Response Network Facilities.' In addition, Wilbur Chen, MD, Chair of the Ebola Vaccine Working Group at the University of Maryland School of Medicine, presented an Overview. Caitlin Cossaboom, DVM, Ph.D., MPH, presented policy questions.

The U.S. FDA granted a Priority Review and a Tropical Disease Priority Review Voucher on September 17, 2019. The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine. On December 19, 2019, the FDA announced the licensing of the Ervebo (rVSVΔG-ZEBOV-GP) Ebola Vaccine. On February 15, 2020, Merck announced that African countries, including the Democratic Republic of the Congo, Burundi, Ghana, and Zambia, had approved the use of Ervebo. On January 8, 2021, the U.S. CDC's Advisory Committee on Immvaccine Practices (ACIP) recommended the use of the rVSVΔG-ZEBOV-GP Ebola vaccine (Ervebo) in the U.S. for preexposure vaccination for adults aged ≥18 years who are at the highest risk for potential occupational exposure to Ebola virus species Zaire ebolavirus because they are responding to an outbreak of EVD, work as health care personnel at fedCDC'sy designated Ebola treatment centers in the USA, or work as laboratorians or other staff at biosafety level 4 facilities in the USA.

INO-4201 Booster Dose

A Phase 1b clinical trial evaluated the DNA vaccine candidate INO-4201 as a booster in healthy adult participants who had previously received a single injection of Ervebo. The prosecution was well tolerated and boosted humoral responses in all 36 participants (100%).

Thermostable Second-Generation Zaire Ebolavirus Vaccine

In November 2022, Hilleman Laboratories announced a collaboration with MSD to develop a thermostable second-generation Zaire ebolavirus vaccine candidate, building on MSD's approved ERVEBO®. In November 2023, SK Bioscience forged a development licensing agreement with Hilleman Laboratories for this second-generation Zaire Ebola virus vaccine candidate.

Ervebo Vaccine Price

This vaccine is not commercially available in the U.S. This UNICEF table shows the awarded price per dose, product, supplier, and calendar year based on a multi-year supply. Additional Ebola vaccine price information is available at InstantRx™.

Ervebo Vaccine News

September 14, 2025 - An initial 400 doses of the Ervebo Ebola vaccine—from the DRC's stockpile of 2000 doses prepositioned in the capital Kinshasa—have been delivered to Bulape.

September 4, 2025 - Health authorities in the Democratic Republic of the Congo announced that 2000 doses of Ervebo are already prepositioned in Kinshasa and will be quickly moved to Kasai to vaccinate contacts and frontline health workers.   

December 4, 2024 - Sierra Leone became the first country to launch a preventive Ebola vaccination campaign targeting 20,000 frontline workers in all 16 districts nationwide.

November 28, 2023, 9News reported that the staff at the Denver Health Regional Emerging Special Pathogen Treatment Center received the Ervebo vaccine as a preventive measure.

September 7, 2023 - "The European Commission's expanded approval of ERVEBO for children one year of age and older is an important milestone for the prevention of disease caused by Zaire ebolavirus," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.

April 27, 2022 - The DRC launched an Ebola vaccination in Mbandaka to halt the spread of the virus following an outbreak that has claimed two lives since April 21. Around 200 doses of the rVSV-ZEBOV Ebola vaccine will be deployed.

February 8, 2022 - A study published by PNAS examined the antibody response at 21 days and six months postvaccination after a single dose of rVSVΔG-ZEBOV-GP among EVD-exposed and potentially exposed populations in the DRC. At 21 days of follow-up, 87.2% had an antibody response. Additionally, 95.6% demonstrated antibody persistence at the six-month follow-up. These findings prove that antibody response and persistence after Ebola vaccination are robust in outbreak settings in the DRC.

November 3, 2021: The U.S. CDC's vaccine advisory committee voted to support vaccines as PrEP for certain healthcare personnel and/or lab support staff at facilities that handle Ebola virus specimens.

October 13, 2021—The WHO confirmed that a vaccination program related to the new Ebola outbreak had been launched in the DRC.

October 11, 2021 - The CEO of GAVI Tweeted,' About 1,000 doses of the rVSV-ZEBOV vaccine are still available in the country (DRC), so vaccination can start immediately to contain this outbreak. And 248,500 supported doses are available in the global stockpile and ready to ship in case of. Need' @GaviSeth.

January 27, 2021—The journal Nature published a new study titled "Ebola virus antibody decay: stimulation in a high proportion of survivors." The study observed the highest antibody reactivity around 200 days after recovery. The model suggests that EBOV antibody reactivity declines over 0.5–2 years after recovery. In a high proportion of healthy survivors, antibody responses undergo rapid restimulation.

February 14, 2020 - Merck confirmed that four African countries approved the ERVEBO vaccine. ERVEBO has now been registered in the following African countries: DRC, Burundi, Ghana, and Zambia.

December 1920—The U.S. FDA announced the approval of Ervebo, the first FDA-approved vaccine for preventing the Ebola virus disease caused by the Zaire ebolavirus.

May 23, 2019 - The School of Public Health Ethics Committee of the University of Kinshasa approved the compassionate belt vaccination protocol amendment for the rVSV-ZEBOV vaccine to expand its targets to pregnant women after the first trimester and lactating women identified as contacts. It is maintained that children can be vaccinated from 6 years old. Between November 26, 2018, and May 26, 2019, 319 pregnant women and 603 lactating women who were registered as contacts were unable to receive vaccination.

July 25, 2016 - Merck announced two regulatory milestones for its investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to the vaccine candidate, and the European Medicines Agency has granted PRIME status.

December 23, 2015: Merck announced the Emergency Use Assessment and Listing application for its investigational Ebola Zaire vaccine, V920 (rVSV∆G-ZEBOV-GP, live attenuated), which the World Health Organization accepted for review.

Ervebo Clinical Trials

Merck Announces FDA Approval for ERVEBO® (Ebola Zaire Vaccine, Live). Clinical trial information is available on the Merck Vaccines website.

Typhim Vi® Vaccine Clinical Trials, Dosage, Indication, News

Typhim VI® (Typhoid Vi Polysaccharide Vaccine) is a sterile solution prepared from the purified polysaccharide capsule of Salmonella typhi (Ty 2 strain). The purified polysaccharide capsule is diluted in an isotonic buffer solution that contains phenol as a preservative, sodium chloride, disodium phosphate dihydrate, monosodium phosphate dihydrate, and water for injection. Typhim VI protects against the risk of infection related to Salmonella typh i. Still, it does not confer vis-à-vis protection of Salmonella Paratyphi A or B or non-typhoid salmonella.

First licensed in 1988 in France, the Typhim Vi® vaccine, manufactured at Sanofi Pasteur's facility in Marcy L'Etoile, France, has established a longstanding safety and seroprotection track record. The U.S. Food and Drug Administration (FDA) updated information (STN#: 103936) was posted in March 2020, Package Insert (TYPHOID VI POLYSACCHARIDE VACCINE TYPHIM VI®).

On February 1, 2024, BMC published a study—A phase II clinical trial of a Vi-DT typhoid conjugate vaccine in healthy Indonesian adolescents and adults: one-month evaluation of safety and immunogenicity—that concluded the Vi-DT typhoid conjugate vaccine is safe and immunogenic in healthy Indonesian subjects 12 to 40 years old.

Sanofi Pasteur is the vaccine division of the French multinational pharmaceutical company Sanofi.

Typhim VI Vaccine Indication

People who are actively ill with typhoid fever and people who are carriers of the bacteria that cause typhoid fever can both spread the bacteria to other people. When someone eats or drinks contaminated food or drink, the bacteria can multiply and spread into the bloodstream, causing typhoid fever. Typhim VI is indicated for use to protect against Typhoid Fever in adults and children over two years of age. Travelers going to endemic areas, migrants, health personnel, and soldiers should consider being vaccinated. A single injection provides protection; however, if the risk of exposure is maintained and depending on the exposure level, revaccination should be performed every 2 to 3 years. Immunity appears between 1 to 3 weeks after the injection. The term of protection is approximately three years.

Typhim VI Dosage and Side Effects

Typhim VI is administered as an intramuscular injection. The vaccine is overall 74% in adults and 55% in children. The safety profile has been reassessed based on clinical studies (15,000 people) and population surveillance. The most common side effects reported in children and adolescents (aged 2 to 17 years) are injection site reactions (pain: 53%; swelling or induration: 16%; redness: 14%), muscle pain (15%), and headaches (13%). In adults, pain at the injection site (76%), muscle pain (47%), and fatigue (25%).

Typhim VI News 2011 - 2022

June 21, 2022—The Lancet published a study that found Independent acquisition of plasmids and homoplastic mutations conferring antimicrobial resistance have occurred repeatedly in multiple lineages of S Typhi, predominantly arising in South Asia before spreading to other regions.

May 12, 2021 - The U.S. CDC confirmed the outbreak of extensively drug-resistant typhoid fever in Pakistan is ongoing

February 12, 2021 - U.S. CDC reports extensive drug-resistant salmonella typhi infections among U.S. residents without international travel.

September 30, 2020 - Travel Alert: Extensive drug-resistant typhoid fever in Pakistan. The CDC recommends that all travelers (even short-term travelers) to South Asia, including Pakistan, be vaccinated against typhoid fever before travel.

June 23, 2011 - the WHO granted Sanofi Pasteur's Typhim Vi® prequalification. WHO prequalification is a crucial step that allows for the procurement of vaccines by UNICEF and other United Nations (UN) agencies like the Pan American Health Organization (PAHO) Revolving Fund. It is also a prerequisite for GAVI Alliance New and Underused Vaccines Support for vaccine distribution. It ensures and improves developing countries' access to vaccines that meet unified quality, safety, and efficacy standards.

Typhim VI Clinical Trials

NCT02645032: Phase 1 Trial of the Safety and Immunogenicity of a Vi-DT Typhoid Conjugate Vaccine Last Update Posted on April 28, 2020.

NCT03460405: Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine in Indonesian Adults, Adolescents, Children and Infants. 

Stamaril® Yellow Fever Vaccine Clinical Trials, Dosage, Efficacy, Side Effects, Usage

Sanofi Stamaril® (17D-YFV, 17D-213) is a live, attenuated yellow fever vaccine containing the active Yellow fever virus 17D-204 strain produced in specified pathogen-free chick embryos. This yellow fever vaccine contains less than one mmol of sodium (23 mg) per dose, essentially "sodium-free," and less than one mmol of potassium (39 mg) per dose. In addition, this yellow fever vaccine contains approximately 8 mg of sorbitol per dose. Efficacy results, including neutralizing antibodies and a robust T-cell response, were reported in a peer-reviewed 2016 study. In addition, the humoral and cellular immunity elicited by 17D has been well characterized in humans, according to the World Health Organization (WHO).

The duration of protection against yellow fever after a single 0.5 mL dose of Stamaril is expected to be at least 10 years. The 17D line of yellow fever virus vaccines is among the most effective vaccines ever created, according to a 2017 study. Stamaril is considered investigational in the U.S. and is not a U.S. Food and Drug Administration (FDA) licensed product. As of May 6, 2021, shipments of Stamaril under the U.S. Expanded Access Program were discontinued. Product information is available in Canada, Australia, and the UK. On July 4, 2021, the European Medicines Agency (EMA)  published EMEA/169383/2006. Various E.U. countries authorize Stamaril. Stamaril's ATC code is J07BL; the Drugbank Accession Number is DB10805. 

With some exceptions, a single dose of the YF vaccine appears to confer lifelong protective immunity against YF disease. Reinforcing immunization (booster dose) should be offered to a small subset of travelers who may be at continued risk, such as those traveling to the UK, according to the Health Security Agency guidance.

Sanofi is a global biopharmaceutical company dedicated to supporting people through their health challenges, with a focus on human health.

Stamaril Vaccine Availability 2025

As of 2025, Stamaril is available in 70 countries; however, the United Kingdom was not among them in late June 2025. However, the UK expects to have access to Stamaril on August 15, 2025.

Sanofi Pasteur's Stamaril has been offered in Europe, including Scotland and the UK, as well as in Uganda, Nigeria, New Zealand, the Republic of Congo, and the Americas Region, including Argentina, Brazil, and Colombia. Between 2023 and 2024, over 80 million people in Africa were protected through vaccination campaigns. In April 2024, Uganda's Karamoja, Teso, Masaka, Ankole, and Kampala Metropolitan regions are among the areas where 14 million people are being vaccinated. The WHO strategy, led by PAHO, aims to vaccinate nearly 1 billion people by 2026. From January 2021 to August 2022, a total of 3,991,568 persons were vaccinated with Stamaril.

Stamaril Coadministration

A non-peer-reviewed study conducted by researchers in Europe evaluated the safety and immunogenicity of the simultaneous delivery of the Yellow fever virus (YFV) vaccine with Tickborne encephalitis virus (TBEV) and Japanese encephalitis virus (JEV) vaccines in an open-label, non-randomized clinical trial. Published on July 11, 2022, the Conclusions are: Inactivated TBEV or JEV vaccines can be coadministered with the live attenuated YFV vaccine without an increased risk of adverse events and reduced development of nAbs to the respective viruses. Furthermore, the vaccines can be safely administered in the same upper arm without adverse outcomes.

Stamaril Indication

Stamaril vaccination is indicated for active immunization against yellow fever for adults and children aged nine months and older when traveling to, passing through, or living in an endemic area, traveling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary), and handling potentially infectious materials (e.g., laboratory personnel). The vaccine should be given at least ten days before entering an endemic area, as protective immunity may not be achieved until this time has elapsed. Children aged 6-9 months should be vaccinated only under exceptional circumstances.

On November 16, 2021, the UK Medicines and Healthcare Products Regulatory Agency published a standardized pre-vaccination checklist to ensure the yellow fever vaccine is indicated for the intended travel destination and to enable vaccinators to identify existing contraindications or precautions in individuals before vaccination.

Stamaril Dosage

The Stamaril yellow fever vaccine should be administered at least ten days before entering an endemic area, as protective immunity may not be achieved until this time has elapsed. According to the CDC, Stamarila is a single, 0.5-milliliter dose given to adults and children from 9 months of age. However, a yellow fever booster with one dose (0.5 milliliters) may be necessary if you or your child had an insufficient response to the first dose or if it has been at least ten years since the initial dose, as required by some countries as a condition of entry, according to the CDC.

Stamaril Fractional Dose

The Lancet Infectious Diseases published a study on April 28, 2023: Immunogenicity and safety of fractional doses of 17D-213 yellow fever vaccine in children: a randomized, double-blind, non-inferiority substudy of a phase 4 trial. Conclusions: Fractional doses of the 17D-213 vaccine were non-inferior to standard doses in inducing seroconversion 28 days after vaccination in children aged 9–59 months when assessed with PRNT50. However, we found fewer children seroconverted at ten days. The results support the use of fractional doses of yellow fever vaccines in WHO recommendations for outbreak response in the event of a yellow fever vaccine shortage, including in children. A 2018 study reported that a one-fifth fractional dose of the Stamaril yellow fever vaccine elicits protective antibodies. However, this suggestion is not approved by the FDA, CDC, or EMA.

Stamaril Side Effects

According to a study published on March 31, 2023, 627.079 individuals received STAMARIL from May 2017 through June 2021; of these, 1308 (0.2%) reported at least one adverse event (AE), of which 122 reported at least one Severe AE. The following serious side effects have sometimes been reported, including Allergic reactions. In addition, reactions affecting the brain and nerves may occur within one month of the vaccination and sometimes be fatal.

Stamaril Women

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your healthcare professional for advice. You should not receive STAMARIL during pregnancy or breastfeeding unless this cannot be avoided. Also, you are recommended not to become pregnant within one month after receiving STAMARIL. Your healthcare professional can advise you on whether you must be vaccinated. If vaccination is needed, it is recommended to interrupt breastfeeding for at least two weeks after receiving STAMARIL. Consult your healthcare professional if you receive the vaccine while pregnant or breastfeeding.

The CDC says, 'the Yellow fever vaccine has been given to many pregnant women without any apparent adverse effects on the fetus. However, because the yellow fever vaccine is a live-virus vaccine, it poses a theoretical risk, according to the CDC. Pregnant women should avoid or postpone travel to an area with a risk of yellow fever. If travel cannot be avoided, discuss vaccination with your healthcare provider before departure,' says the CDC.

Stamaril and HIV

The Lancet published a study on April 28, 2023, that provides confidence that fractional dose recommendations apply to populations with high HIV prevalence.

Stamaril Immunocompromised

Randomized and quasi-randomized clinical trials and observational studies that included immunocompromised participants (individuals with HIV infection, organ transplants, and cancer who used immunosuppressive drugs for rheumatologic diseases and those on immunosuppressive therapy for other diseases) were selected. Study Conclusions - It is impossible to affirm that immunocompromised individuals, regardless of etiology, have a higher risk of adverse events after receiving the YF vaccine.

Stamaril Vaccine News

June 27, 2025 - There will be a brief disruption in the supply of the yellow fever vaccine, Stamaril, in the UK.

November 8, 2024 - The Republic of Colombia recently conducted a Stamaril vaccination campaign. 

April 11, 2024 - Uganda launches phase 2 of the yellow fever vaccination campaign for 14 million people.

January 4, 2024 - Phylogenetic analysis reveals a new introduction of the Yellow Fever virus in São Paulo State, Brazil, 2023.

April 28, 2023 - The Lancet published an article: Fractional dose yellow fever vaccination, coming of age.

March 15, 2023 - Uganda launched an extensive vaccination program (1.9 million) for children.

February 8, 2023—The Tribune Online reported that Nigeria's Bayelsa State Government declared a state of emergency regarding yellow fever vaccination.

January 3, 2022 - The WHO Africa reported that 4,385,320 persons were vaccinated in Cameroon, the Central African Republic, Chad, Ghana, and Kenya from 2021 through December 7, 2022.

December 12, 2022 - The WHO Africa reported that 81 children received life-saving yellow fever vaccines in eastern Nigeria.

September 22, 2022 - The Republic of Uruguay required proof of a yellow fever vaccine for certain people visiting or departing from the country.

August 5, 2022 - The Republic of the Congo launched a yellow fever vaccination campaign to vaccinate 4 million people.

March 2, 2022 - The temporary low-stock situation in the UK has been resolved.

December 1, 2021—The WHO reported that since November 6, 2021, a focused vaccination campaign targeting 54,964 people aged 6 months to 60 years (excluding pregnant women) has been conducted in over 80 communities in the West and North Gonja districts of the Savannah region. The International Coordinating Group on Vaccine Provision for Yellow Fever has approved a campaign targeting 361,165 people (9 months to 60 years) in five affected districts.

April 2021—The U.S. CDC confirmed Pasteur's announcement that YF-VAX is once again available for purchase in the U.S.

March 9, 2021 - The Canadian Committee to Advise on Tropical Medicine and Travel Interim Canadian recommendations for using a fractional yellow fever vaccine during a vaccine shortage.

June 25, 2020 - To help meet the continued yellow fever vaccination needs in the U.S., STAMARIL® (Yellow Fever Vaccine [Live]) will continue to be available throughout 2020.

December 23, 2019 – To help meet the continued demand for the yellow fever vaccine in the USA, the manufacturer of the STAMARIL vaccine announced that it would continue to be available throughout 2020.

May 8, 2019 – A long-term study found no evidence that a YF vaccination in dengue-endemic areas increased the risk of severe dengue fever.   

May 2, 2019 – The FDA licensed a new state-of-the-art Yellow Fever Vaccine production facility in the USA.

November 27, 2018 – A study reported that a one-fifth fractional dose of the Stamaril (17D-YFV) yellow fever vaccine delivers protective antibodies for up to 10 years.

Stamaril Yellow Fever Vaccine Clinical Trials

Sanofi's Stamaril yellow fever vaccine has been involved in multiple clinical trials.

Phase 4 Clinical Trial NCT02991495: Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines. Last Update Posted: December 17, 2020. Estimated Study Completion Date: May 31, 2021. This study aims to answer research questions that will broaden the recommendations for the use of fractional doses of the yellow fever vaccine in emergencies. The study will be conducted in Uganda and Kenya. The primary objective of assessing non-inferiority is to compare seroconversion rates 28 days after vaccination with a fractional dose to those with the total amount for each WHO-prequalified manufacturer. In addition, the Safety Monitoring Board will review the main outcome vaccine results for the studies in children and HIV-positive adults.

Phase 3 Clinical Trial NCT03541694: Passive Enhanced Safety Surveillance of Stamaril Vaccine in Korea. Last Update Posted: March 26, 2019. This is a passive enhanced safety surveillance study of the Stamaril vaccine in Korea. The objective is to collect suspected adverse events related to vaccination with Stamaril in routine practice.

A Phase I, open-label, randomized, controlled clinical study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC), or STAMARIL® (Sanofi-Pasteur) in a 1:1:1 ratio. They were followed for solicited reactions over 10 days, unsolicited events over 28 days, and serious adverse events over 3 months. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, and 28. A total of 60 adults were enrolled in the study. The proportions of participants with solicited reactions were 10%, 40%, and 25% in the SII YFV SC, SII YFV IM, and STAMARIL® arms, respectively. No causally related unsolicited events or serious adverse events were reported. After vaccination, seroconversion rates were 94.44%, 100%, and 100% in the three arms, respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found to be safe and immunogenic when administered by both IM and SC routes. The vaccine can be tested in further phases of clinical studies.