Sanofi Pasteur Statement on YF-VAX® Vaccine Return to Supply & STAMARIL® Importation

Apr 29, 2019

YF-VAX VACCINE RETURN TO SUPPLY MEDIA STATEMENT:
Sanofi Pasteur’s new state-of-the-art YF-VAX® (Yellow Fever Vaccine) production facility has been licensed by the U.S. FDA and the transition of production continues.  Frequently, when a new vaccine manufacturing facility comes online, it may take some time to achieve consistent vaccine supply levels.  We are currently reassessing the YF-VAX return to supply timing and will provide an update by the end of 2019.  Vaccine manufacturing is a complex biological process that is highly regulated.  Consequently, the construction and validation of a new facility often takes several years to bring a new facility online.  We remain committed to supplying yellow fever vaccine to meet the needs of public health.  Thus, the STAMARIL® (Yellow Fever Vaccine [Live]) Expanded Access Program (EAP) will continue until the return of YF-VAX vaccine. 

Sanofi Pasteur continuously works to improve our processes to maintain a consistent supply of quality vaccine.  All appropriate efforts are being made to resolve the YF-VAX vaccine supply interruption.  This includes investing in dedicated resources to facilitate the return of YF-VAX vaccine.  Through its vaccines, Sanofi Pasteur has a decades-long history of helping protect public health.  The development and production of high quality, safe and effective vaccines and biological products remains our highest priority.

STAMARIL® IMPORTATION MEDIA STATEMENT:
Recognizing the importance of yellow fever vaccination for military personnel and international travelers, 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 Pasteur has worked with the FDA to distribute STAMARIL® (Yellow Fever Vaccine [Live]) through an Expanded Access Program (EAP) during the YF-VAX vaccine shortage until 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.

The EAP allows the importation and use of STAMARIL vaccine in place of YF-VAX vaccine to fulfill U.S. yellow fever immunization demand until production of YF-VAX vaccine resumes. Our goal is to support continued access to yellow fever vaccination for travelers to international destinations where 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. Geographic location of sites was also a key consideration. The objective is to provide the broadest access possible to yellow fever vaccine, given the regulatory requirements of the EAP.                                                                                                                   

Health care providers and patients can find locations that can administer STAMARIL vaccine by visiting the CDC web page at http://wwwnc.cdc.gov/travel/yellow-fever-vaccination-clinics/search.  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.

Bringing answers to the global threat posed by yellow fever is a key commitment for Sanofi Pasteur. We are making every effort to see that yellow fever vaccination continues in the U.S. during this YF-VAX vaccine supply disruption.

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.

For more information about YF-VAX vaccine, talk to your health care professional.

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 YF-VAX Vaccine Prescribing Information.
Please see Full STAMARIL Patient Leaflet.