Stamaril® Yellow Fever Vaccine For 2022
Stamaril® (17D-YFV) is a live, attenuated yellow fever vaccine containing the active Yellow fever virus 17D-204 strain produced in specified pathogen-free chick embryos. The 17D line of yellow fever virus vaccines is among the most effective vaccines ever created, stated a 2017 study. In addition, the humoral and cellular immunity elicited by 17D has been well characterized in humans, says the WHO.
The duration of protection following administration of one single 0.5 mL dose of STAMARIL is expected to be at least ten years. This medicine contains less than one mmol sodium (23 mg) per dose, essentially "sodium-free," and less than one mmol potassium (39 mg) per dose. In addition, this yellow fever vaccine contains approximately 8 mg of sorbitol per dose.
Sanofi Pasteur's Stamaril has been offered in Europe, Scotland, the U.K., Uganda, and other countries for decades. Stamaril yellow fever vaccine is currently registered and distributed in over 70 countries. However, Stamaril is considered investigational in the USA and is not a U.S. FDA-licensed product. As of May 6, 2021, shipments of STAMARIL in the U.S. as part of the Expanded Access Program were discontinued. The YF-Vax vaccine is approved by the U.S. FDA.
Search for Yellow Fever Vaccination Clinics at this weblink. Product information is available on this weblink, as is Canada and Australia. ATC code: J07BL; Drugbank Accession Number: DB10805.
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Stamaril Yellow Fever Vaccine History
On July 4, 2021, the EMA EMEA/169383/2006 published SUMMARY INFORMATION FOR STAMARIL, which can be authorized by E.U. countries. Among more than 500 million vaccinees, only a handful of cases have been reported in which vaccinees developed a virulent wild-type YFV infection. This efficacy results from neutralizing antibodies and a robust T cell response reported in a 2016 study.
Stamaril Yellow Fever Vaccine Indication
On November 16, 2021, the U.K. 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.
The Yellow fever vaccine can prevent yellow fever. Yellow fever is a severe disease caused by the yellow fever virus. Most people with yellow fever virus infections will have mild disease symptoms or completely recover. But some people will develop severe disease, says the CDC. The vaccine should be given at least ten days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed.
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).
Stamaril Yellow Fever Vaccine Dosage
The Stamaril yellow fever vaccine should be given at least ten days before entering an endemic area since protective immunity may not be achieved until this time has elapsed. Stamaril is provided as a single, 0.5-milliliter dose to adults and children from 9 months of age, says the CDC. Stamaril yellow fever vaccine is given as an injection by an authorized healthcare provider. It is usually injected just underneath the skin, but it can be delivered into a muscle. It must not be injected into a blood vessel. The protection provided by this dose is expected to last at least ten years and could be life-long.
A yellow fever booster with one dose (0.5 milliliters) may be needed: - if you or your child had an insufficient response to the first dose - or after at least ten years if required as a condition of entry in some countries, says the CDC.
A study published in 2018 reported that a one-fifth fractional dose of the Stamaril yellow fever vaccine delivers protective antibodies. However, this suggestion is not FDA or CDC-approved.
Stamaril Yellow Fever Vaccine Side Effects
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 have sometimes been fatal.
Stamaril Yellow Fever Vaccine Use With Pregnant Women
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your healthcare professional for advice before being vaccinated. You should not receive STAMARIL during pregnancy or breastfeeding unless this cannot be avoided. Also, it is recommended that you do not 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. But, since the yellow fever vaccine is a live virus vaccine, it poses a theoretical risk, says the CDC. And, '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.
Yellow Fever Vaccine & Malaria Prophylaxis Information by Country
The following pages present country-specific information on the yellow fever vaccine requirements and recommendations, malaria transmission information, and prophylaxis recommendations.
Stamaril Yellow Fever Vaccine News For 2020 - 2022
May 4, 2022 - An Alert - Level 2, Practice Enhanced Precautions, was issued by the U.S. CDC issued regarding Nigeria's yellow fever outbreak. The outbreak is currently in Bauchi, Benue, Delta, Ebonyi, and Enugu states. Unless vaccinated, travelers should not visit these areas. Nigeria's ongoing outbreak was first reported in November 2020. Furthermore, the December 2021, Level 2 Alert for Yellow Fever in Ghana continues to be in effect.
April 25, 2022 - The WHO Africa reported five of the six yellow fever cases investigated in Uganda had a recent history of vaccination and were consequently discarded in the absence of evidence suggesting vaccination failure, and one case (reported from Wakiso district) was confirmed as yellow fever.
March 25, 2022 - The WHO reported during the period 12 January to 15 March 2022, a total of 53 suspected yellow fever cases, including six deaths, have been reported from Isiolo County, central Kenya. The last reported yellow fever outbreak in Kenya was in 2011. WHO assesses the public health risk as high at the national and regional levels. According to WHO-UNICEF, at the national level, the overall estimated coverage through routine yellow fever immunization is 7% of the target population.
March 2, 2022 - The temporary low stock situation in the U.K. has been resolved. There are currently no order restrictions on the yellow fever vaccine (Stamaril).
February 14, 2022 - The U.K government issued a statement: Sanofi Pasteur is currently experiencing temporary low stock of yellow fever vaccine (Stamaril). The situation is expected to be resolved by late February 2022.
December 13, 2021 - The U.S. Centers for Disease Control and Prevention issued a Level 2 Travel Advisory for the yellow fever outbreak in Ghana. Since October 2021, there has been a yellow fever outbreak in Ghana with numerous cases, including some deaths, in the following regions: Savannah, Upper West, Bono, and Oti.
December 1, 2021 - The WHO reported since November 6, 2021, a focused vaccination activity targeting 54,964 people aged six months to 60 years (excluding pregnant women) is being conducted in over 80 communities in the West and North Gonja districts, Savannah region. The International Coordinating Group on Vaccine Provision for Yellow Fever has approved a campaign targeting 361,165 people (9 months - 60 years) in five affected districts.
November 19, 2021 - The Ghana Health Service (GHS) has intensified surveillance in the Savannah and Upper West Regions. GHS has recorded 25 Yellow Fever deaths with 18 hospital admissions in the two regions.
November 16, 2021 - The U.K.'s new vaccination consultations checklist ensures systematic evaluation of benefits and risks for individual travelers. However, the checklist is not a replacement for the entire travel health risk assessment by a qualified practitioner, and other lists or materials may also be used before vaccination, depending on clinical guidance.
October 14, 2021 - Venezuela's Yellow Fever Outbreak Includes Humans and Epizootics.
October 13, 2021 - The WHO reported the Bolivarian Republic of Venezuela had confirmed an ongoing yellow fever disease outbreak. The reported cases include a young pregnant woman with a history of yellow fever vaccination. Of the remaining six patients, five were male and ranged between 24 and 82 years of age, were not vaccinated.
September 30, 2021 - There is an outbreak of yellow fever in Nigeria, first reported in November 2020. The U.S. CDC says, 'Travelers to Nigeria should take steps to prevent yellow fever by getting vaccinated at least ten days before travel.'
June 30, 2021 - The U.S. CDC issued a Travel Alert confirming that travelers to Nigeria should take steps to prevent yellow fever by getting vaccinated at least ten days before travel and preventing mosquito bites. The outbreak is currently in Bauchi, Benue, Delta, Ebonyi, and Enugu states. Therefore, unless vaccinated, travelers should not visit these areas.
April 5, 2021 - The U.S. CDC confirmed Sanofi Pasteur announced that YF-VAX is once again available for purchase in the United States. Providers with a current Yellow Fever Vaccination Stamp issued by their state or territorial health department may now order YF-VAX from the manufacturer.
March 9, 2021 - The Canadian Committee to Advise on Tropical Medicine and Travel (CATMAT) Interim Canadian recommendations for using a fractional dose of yellow fever vaccine during a vaccine shortage. Notice to reader: This statement has been rescinded and is no longer valid as the shortage of the Yellow Fever vaccine has been lifted. CATMAT recommends that anyone who received a fractional dose of the Yellow Fever vaccine while the shortage was in effect should now get a regular dose of the vaccine if traveling to an area where yellow fever vaccination is recommended or required.
March 7, 2021 - To reduce yellow fever outbreaks at the province level, researchers could quantify preventive mass vaccination campaigns (PMVC) using the self-controlled case series method. PMVCs in Africa averted an estimated 22% to 45% of outbreaks during this study period.
February 18, 2021 - A new study, 'Assessing the impact of preventive mass vaccination campaigns on yellow fever outbreaks in Africa: A population-level self-controlled case series study.' provides new empirical evidence of the high preventive impact on PMVCs yellow fever outbreaks. This study published by PLOS Medicine illustrates that the SCCS method can be advantageously applied at the population level to evaluate a public health intervention. Furthermore, these results may encourage rapid rescheduling of yellow fever PMVCs postponed due to the COVID-19 pandemic.
December 23, 2020 - Sanofi Pasteur announced, 'All reasonable efforts are being made to resolve the YF-VAX vaccine supply interruption. This includes investing in dedicated resources to facilitate the YF-VAX vaccine's return. Sanofi Pasteur has a decades-long history of helping protect public health through its vaccines. The development and production of high quality, safe and effective vaccines and biological products remain our highest priority.'
November 24, 2020 - Reports of a cluster of deaths from an undiagnosed disease were notified through Event-Based Surveillance in two states, Delta and Enugu, located in southern Nigeria. A preliminary report for Delta State on November 5, 2020, declared 48 suspected yellow fever cases (Y.F.) with 30 deaths (CFR 62.5%). The Y.F. vaccination status of most of the suspected cases is unknown. The index case developed symptoms on July 24, 2020, and died on July 28, 2020. The preliminary investigation did not reveal any significant travel history.
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. In addition, Sanofi Pasteur has worked with the FDA to distribute STAMARIL through an Expanded Access Program (EAP) during the YF-VAX vaccine shortage until the YF-VAX vaccine production resumes in its new facility.
May 7, 2020 - The Lancet article: Prevention of yellow fever in travelers: an update.
May 6, 2020 - A lesson from history: How the yellow fever epidemic changed society.
April 23, 2020 - There is an outbreak of yellow fever in Ethiopia's Southern Nations Nationalities and Peoples Region.
April 20, 2020 - A large, ongoing outbreak of yellow fever in Nigeria began in September 2017. The outbreak is now spread throughout the country. The Nigerian Ministry of Health has reported the disease in all 36 states and the Federal Capital Territory.
March 1, 2020 - The Ethiopia Public Health Institute has reported an outbreak of yellow fever in Ethiopia's Southern Nations Nationalities and Peoples Region.
January 23, 2020 - Travel Vaccines Promote Public Health.
December 23, 2019 – To help meet the continued yellow fever vaccine consumer demand in the USA, the manufacturer of the STAMARIL® vaccine announced it would continue to be available throughout 2020. Sanofi Pasteur continued by saying 'Since 2016, it has recognized the importance of yellow fever vaccination to protect people and has been working with FDA and other stakeholders to ensure the STAMARIL vaccine remains available for travelers, U.S. government employees, military, and other response groups during the anticipated shortage period.'
May 8, 2019 – A new, long-term study found no evidence that a Yellow Fever virus vaccination in dengue-endemic areas increased Severe Dengue Fever risk.
May 2, 2019 – A new state-of-the-art Yellow Fever Vaccine production facility in the USA has been licensed by the Food & Drug Administration.
November 27, 2018 – A new study reported that a one-fifth fractional dose of the Stamaril (17D-YFV) yellow fever vaccine delivers protective antibodies for up to 10 years.
April 12, 2018 - NPR reported: Yellow Fever Encroaches Megacities, Straining Global Vaccine Supply.
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 respond to some of the research questions that would broaden the recommendations on using fractional doses of yellow fever vaccine emergencies. The study will be conducted in Uganda and Kenya. The main objective of assessing the non-inferiority is seroconversion 28 days after vaccination of a fractional dose compared to the full dose 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 passive enhanced safety surveillance of the Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.