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Sanofi Pasteur Statement On YF-VAX® Shortage & STAMARIL® Importation

Sanofi Pasteur confirms that YF-VAX® (Yellow Fever Vaccine) is unavailable to order in the U.S. until mid-2018 as the company transitions production to a new state-of-the-art facility, which is expected to occur in 2018. Contingency plans have been put in place since March 2016 when the company implemented ordering restrictions to responsibly manage supply.

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 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 Investigational New Drug 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. These 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.  New sites will be added as they complete the certification process. 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. Sanofi Pasteur recognizes the challenge this supply disruption will cause for customers and for patients in need of yellow fever vaccine. 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 Prescribing Information

STAMARIL Prescribing Information

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