Yellow Fever Vaccine Information
Sanofi Pasteur’s new U.S. YF-VAX® (Yellow Fever Vaccine) production facility has been licensed by the U.S. Food and Drug Administration (FDA) and doses continue to progress through manufacturing. We expect to have more information on the return of YF-VAX in June 2021. The Expanded Access Investigational New Drug Application Program (EAP) will continue into 2021.
In the U.S., Sanofi Pasteur has worked with the FDA to provide access to another yellow fever vaccine through this EAP. Manufactured by Sanofi Pasteur in France, this vaccine, STAMARIL® (Yellow Fever Vaccine [Live]), is registered and distributed in more than 70 countries. However, it is considered investigational in the U.S., as it is not a U.S.-licensed product.
The EAP has requirements similar to a clinical trial; thus Sanofi Pasteur can support only a limited number of sites. Working closely with the CDC, more than 250 geographically distributed sites throughout the US were identified for inclusion in the program so patients can have continued access to yellow fever vaccine.
Health care providers and patients may find locations that can administer yellow fever vaccine (either YF-VAX or STAMARIL) by visiting the CDC web page at http://wwwnc.cdc.gov/travel/yellow-fever-vaccination-clinics/search. When seeking yellow fever immunization, allow enough time to schedule an appointment with a yellow fever vaccine provider before travel. Providers and patients may also visit http://wwwnc.cdc.gov/travel for information about which countries require yellow fever vaccination for entry and for which countries the CDC recommends yellow fever vaccination.
INDICATION FOR YF-VAX VACCINE
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.
IMPORTANT SAFETY INFORMATION FOR YF-VAX VACCINE
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 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.
Please see Full Prescribing Information for YF-VAX vaccine.
Please see the CDC Vaccine Information statement for Yellow Fever Vaccine.
Please see Full STAMARIL Patient Leaflet.
For more information about yellow fever vaccination, talk to your health care professional.