YF-VAX is prepared by culturing the 17D-204 strain of yellow fever virus in living avian leukosis virus-free (ALV-free) chicken embryos. The vaccine contains sorbitol and gelatin as a stabilizer, is lyophilized, and is hermetically sealed under nitrogen. The YF-VAX vaccine is given to people 9 months of age and older who are at increased risk for yellow fever to help prevent them from getting the disease.
Sanofi Pasteur has been working with U.S. FDA, CDC, DOD, and other stakeholders since 2016 so that vaccination against yellow fever remains available for travelers, U.S. government employees, military, and other response groups during the anticipated shortage period. Sanofi has worked with the FDA to distribute STAMARIL through an Expanded Access Program (EAP) during the YF-VAX vaccine shortage until the production of YF-VAX vaccine resumes in its new facility. STAMARIL vaccine, manufactured by Sanofi Pasteur in France, is a live, attenuated yellow fever vaccine that is investigational/unlicensed in the U.S., but it is registered and currently distributed in over 70 countries.
Sanofi's goal is to support continued access to yellow fever vaccination for travelers to international destinations where the yellow fever vaccine is required or recommended. An EAP is similar to a clinical trial, and a limited number of clinical sites can participate in this program. More than 250 locations have been selected to include sites that immunize the most patients with YF-VAX vaccine. The geographic location of sites was also a key consideration. The objective was to provide the broadest access possible to the yellow fever vaccine, given the regulatory requirements of the EAP.
YF-VAX is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older.
YF-VAX vaccine should not be given to an individual who has experienced a serious allergic reaction to eggs, egg products, or to any component of the vaccine (including gelatin). A severe allergic reaction (eg, anaphylaxis) may occur following the use of YF-VAX vaccine, even in individuals with no prior history of hypersensitivity to the vaccine components.
In addition, the following persons should not receive YF-VAX vaccine: infants younger than 9 months of age, women who are breastfeeding infants younger than 9 months of age, and individuals with a severely suppressed or compromised immune system. Rarely, the yellow fever vaccine has been associated with disease affecting multiple organs, including inflammation of the brain.
The most common side effects to the YF-VAX vaccine include swelling and pain at the injection site; headache, generalized muscle aches or discomfort, and fever. Other side effects may occur. Vaccination with YF-VAX vaccine may not protect all individuals.
YF-VAX is administered as a single subcutaneous injection of 0.5 mL of reconstituted vaccine. Do not administer YF-VAX by intravascular, intramuscular, or intradermal routes. A single dose provides protection for 10 years for most people.
Sanofi Pasteur’s full YF-VAX Vaccine Prescribing Information is available.
December 23, 2019, - Sanofi has worked with the US Food and Drug Administration (FDA) to provide the STAMARIL vaccine through an Expanded Access Program (EAP), during the YF-VAX vaccine shortage.
August 6, 2019 - FDA Expanded Approval Letter for YF-VAX
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 (FDA) and the transition of production of YF-VAX continues, said Sanofi Pasteur in a statement.
June 15, 2016 - FDA Approval Letter - To revise the YF-VAX package insert to align Booster Dosing language with recent changes to International Health Regulations and WHO/ACIP recommendations, and to modify the text throughout the document to clarify and update the presented information.