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

Sep 7, 2018

YF-VAX VACCINE RETURN TO SUPPLY MEDIA STATEMENT:
Sanofi Pasteur continues to transition production of YF-VAX® (Yellow Fever Vaccine) to a new state-of-the-art facility and now expects supply to return in the U.S. by mid-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 with a number of milestones necessary to achieve licensure.  With the most recent testing complete and the progress of the current validation activities confirmed, we adjusted our expectations for the return to supply 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.  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.

YF-VAX Vaccine Prescribing Information
STAMARIL Prescribing Information