Sanofi Pasteur Statement On YF-VAX® Shortage & STAMARIL® Importation
Sanofi Pasteur is experiencing delays in the production process of YF-VAX® (Yellow Fever Vaccine) while we transition production to a new state-of-the-art facility planned for mid-2018. Contingency plans have been put in place since March 2016 when the company implemented ordering restrictions to responsibly manage supply. However, the company anticipates that the product will be unavailable in the U.S. beginning mid-2017 and extending to mid-2018. YF-VAX vaccine will continue to be available while current supplies last.
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 during the YF-VAX vaccine shortage until production 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 Expanded Access IND program 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 Expanded Access IND program 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 and geographic location. The objective is to provide the broadest access possible to yellow fever vaccine, given the regulatory requirements of the Expanded Access IND program.
Once YF-VAX vaccine is no longer available, health care providers and patients will be able to find locations that will administer STAMARIL vaccine by visiting the CDC web page at http://wwwnc.cdc.gov/travel/yellow-fever-vaccination-clinics/search. They 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.