Stamaril is a live, attenuated yellow fever vaccine that contains the active substance Yellow fever virus1 17D-204 strain produced in specified pathogen-free chick embryos.
However, Stamaril is considered investigational in the USA, as it is not an FDA-licensed product. Although the name of the FDA program is "investigational new drug," Stamaril is not investigational or experimental. Stamaril has been used in European and other countries for decades but is not licensed in the United States. IND is the mechanism through which the FDA gives approval for Stamaril to be imported.
The FDA's Expanded Access Program, (EAP) which has requirements similar to a clinical trial has authorized only a limited number of vaccine distribution sites. Working closely with the 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 through 2020. Stamaril yellow fever vaccine is currently registered and distributed in over 70 countries.
Stamaril is indicated for active immunization against yellow fever for adults and children aged 9 months and older:
- 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)
- 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. However, since the yellow fever vaccine is a live virus vaccine, it poses a theoretical risk.
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 prior to departure,’ says the CDC.
Yellow fever infection is diagnosed based on laboratory testing, a person’s symptoms, and travel history. Online lab tests are available at UltaLabs.
The Stamaril yellow fever vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed. Stamaril is given as a single, 0.5-milliliter dose to adults and children from 9 months of age.
Stamaril yellow fever vaccine is given as an injection by a doctor or nurse. 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 first dose should be given at least 10 days before protection from yellow fever is needed. This is because it takes 10 days for the first dose of the yellow fever vaccine to work and provide good protection against the yellow fever virus. 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 milliliter) may be needed: - if you or your child had an insufficient response to the first dose, - or after at least 10 years if it is required as a condition of entry in some countries.
In order to comply with vaccine regulations and to be officially recognized, yellow fever vaccines must be administered in an approved World Health Organization (WHO) vaccination center and registered on an International Certificate of Vaccination. The validity period of this Certificate is established according to International Health Regulations (IHR) recommendations, and starts 10 days after primary vaccination and immediately after re-vaccination.
A study published in 2019 reported that a one-fifth fractional dose of the Stamaril (17D-YFV) yellow fever vaccine delivers protective antibodies for up to 10 years.
Please see Full STAMARIL Patient Leaflet for additional information.
- December 23, 2019 – To help meet the continued yellow fever vaccine consumer demand in the USA, the manufacturer of the STAMARIL® vaccine announced it will continue to be available throughout 2020. Sanofi Pasteur continued 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 the risk of Severe Dengue Fever.
- 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.
Clinical Trial NCT02991495: Immunogenicity and Safety of Fractional Doses of Yellow Fever Vaccines (YEFE)
- In July 2016, the demand for yellow fever vaccines in response to the large urban outbreaks occurring concurrently and the risk of further spread through the African continent and even to Asia, was larger than the available supply.
- In this situation, the World Health Organization (WHO) developed recommendations for the use of fractional-dose of yellow fever vaccine as a dose-sparing strategy. These recommendations were based on a limited number of clinical trials and additional studies should assess the applicability of the fractional dose to all WHO-prequalified vaccines, the persistence of neutralizing antibodies and the performance of the fractional dose in young children and populations in Africa including those with HIV.
- This study aims to respond to some of the research questions that would allow broadening the recommendations on the use of fractional doses of yellow fever vaccine in emergency situations.
- The study will be conducted in Uganda and Kenya and 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.
- As secondary objectives the study will assess seroprotection 10 days and 1 year after vaccination, to assess rapidity and persistence of protective antibody levels; describe the geometric mean titre and the change in neutralizing antibody on Day 28 days after vaccination with fractional and full doses; and assess the occurrence of adverse events and serious adverse events (SAE) during 28 days after administration of fractional and full doses.
- The study consists of a randomized non-inferiority trial.
- The study aims to start in April 2017 in the two sites and aims to recruit 960 adults.
- Results for the main outcome will be reviewed by the study Data and Safety Monitoring Board and one vaccine will be selected for the studies in children and HIV positive adults.
Clinical Trial NCT03541694: Passive Enhanced Safety Surveillance of Stamaril Vaccine in Korea
- This is a passive enhance safety surveillance (ESS) of the Stamaril vaccine in Korea.
- The objective is to collect suspected related adverse events following vaccination with Stamaril in routine practice.