Sanofi Pasteur Statement On YF-VAX® Shortage & STAMARIL® Importation
Sanofi Pasteur is currently experiencing delays in the production process of YF-VAX® (Yellow Fever Vaccine) vaccine while we transition production to a new state-of-the-art facility planned for mid-2018. The delays, which are due to a manufacturing issue at the US-based Swiftwater plant, impact the production of the 1-dose and 5-dose vaccine presentations. Contingency plans have been put in place since March 2016 when the company implemented ordering restrictions to manage supply. However, based on current assumptions, the company anticipates a YF-VAX stock-out in the US beginning mid-2017 and extending to mid-2018. Recognizing the importance of yellow fever vaccination for military personnel and international travelers, Sanofi Pasteur has been working with US FDA, CDC, DoD and other stakeholders so that vaccination against yellow fever remains available for travelers, US government employees, military, and other response groups during the anticipated shortage period.
Sanofi Pasteur worked on a number of contingency plans and pursued multiple paths to support continuous supply of yellow fever vaccine. In addition to ordering restrictions, the company made efforts to increase production in the existing facility. Additionally, Sanofi Pasteur has been granted approval by the FDA to distribute STAMARIL® (Yellow Fever Vaccine) vaccine during the YF-VAX vaccine shortage until production of YF-VAX resumes in its new facility.
STAMARIL vaccine is also produced by Sanofi Pasteur and is registered in more than 100 countries and currently distributed in more than 70 countries. The FDA has evaluated the safety and efficacy of STAMARIL vaccine and the agency has granted the company an “Expanded Access IND” approval.
This allows the importation and use of STAMARIL vaccine in place of YF-VAX to fulfill US yellow fever immunization demand until production of YF-VAX vaccine resumes. Our goal is for travelers to international destinations where yellow fever vaccine is required or recommended to have continued access to yellow fever immunization with STAMARIL vaccine while YF-VAX vaccine is unavailable. Sanofi Pasteur will be able to provide additional details to health-care providers on the introduction of STAMARIL vaccine to the US market in the spring.
Bringing answers to the global threat posed by yellow fever is a key commitment for Sanofi Pasteur. We deeply regret the current supply situation with YF-VAX and are working diligently to sustain availability of yellow fever vaccine.