Stamaril Yellow Fever Vaccine Description
Stamaril is a live, attenuated yellow fever vaccine that contains the active substance Yellow fever virus 17D-204 strain produced in specified pathogen-free chick embryos.
Sanofi Pasteur's Stamaril has been offered in Europe and other countries for decades. Stamaril yellow fever vaccine is currently registered and distributed in over 70 countries. The 17D line of yellow fever virus vaccines is among the most effective vaccines ever created, stated a 2017 study. The humoral and cellular immunity elicited by 17D has been well characterized in humans, says the WHO.
However, Stamaril (17D-YFV) is considered investigational in the USA, not a U.S. FDA-licensed product. The FDA's Expanded Access Program (EAP) has currently authorized a limited number of Stamaril vaccine distribution sites in the USA.
Working closely with the U.S. CDC, geographically distributed sites throughout the USA are identified for inclusion in the EAP program so patients can have continued access to the Stamaril yellow fever vaccine. ATC code: J07BL; Drugbank Accession Number: DB10805
Stamaril Yellow Fever Vaccine History
On December 23, 2020, Sanofi Pasteur announced the 'Expanded Access Investigational Drug Application Program for STAMARIL® (Yellow Fever Vaccine [Live]) would continue into 2021. When the YF-VAX vaccine returns, there will be a brief period of transition to discontinue the STAMARIL EAP.'
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 is presumed to result from neutralizing antibodies and a robust T cell response reported in a 2016 study.
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Stamaril Yellow Fever Vaccine Indication
Yellow fever vaccine can prevent yellow fever. Yellow fever is a serious disease caused by the yellow fever virus. Most people with yellow fever virus infections will either not have mild disease symptoms and completely recover. But some people will develop severe disease, says the CDC.
Stamaril vaccination is indicated for active immunization against yellow fever for adults and children aged 9 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).
Additionally, 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.'
The yellow fever virus is spread to people by the bite of an infected mosquito. Illness ranges from a fever with aches and pains to severe liver disease with bleeding and yellowing skin (jaundice). Yellow fever infections are diagnosed based on laboratory testing, a person’s symptoms, and travel history.
If, for some reason, a woman is vaccinated during pregnancy, she is unlikely to have any problems from the vaccine, and her baby is very likely to be born healthy.
And, ‘pregnant women should avoid or postpone travel to an area where there is a risk of yellow fever. If travel cannot be avoided, discuss vaccination with your healthcare provider before departure,’ says the CDC.
Yellow fever infection is diagnosed based on laboratory testing, a person’s symptoms, and travel history.
Stamaril Yellow Fever Vaccine Dosage
The Stamaril yellow fever vaccine (17D-YFV) should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until this time has elapsed. Stamaril is given 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 given into a muscle. It must not be injected into a blood vessel.
The protection provided by this dose is expected to last at least 10 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 10 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 (17D-YFV) yellow fever vaccine delivers protective antibodies. This suggestion is not FDA nor CDC approved.
Stamaril Yellow Fever Vaccine Updates:
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 of PMVCs on 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. These results may encourage rapid rescheduling of yellow fever PMVCs that have been postponed due to the COVID-19 pandemic.
December 23, 2020 - Sanofi Pasteur announced, ' All appropriate 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, notified 48 suspected yellow fever cases (YF) with 30 deaths (CFR 62.5%). The YF 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. 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 the Southern Nations Nationalities and Peoples Region of Ethiopia.
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 the Southern Nations Nationalities and Peoples Region of Ethiopia.
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's 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.
Stamaril Yellow Fever Vaccine 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 is to assess the non-inferiority is seroconversion 28 days after vaccination of a fractional dose compared to the full dose for each WHO-prequalified manufacturer. The Safety Monitoring Board will review results for the main outcome vaccine selected 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 enhance safety surveillance of the Stamaril® vaccine in Korea. The objective is to collect suspected related adverse events following vaccination with Stamaril® in routine practice.