The nation’s supply of U.S.-licensed YF-VAX yellow fever vaccine is expected to be depleted by mid-2017 due to delays in the manufacturing process at Sanofi Pasteur, according to a recent report published by the U.S. Centers for Disease Control and Prevention (CDC).
YF-VAX is the only yellow fever vaccine licensed for use in the United States and is distributed to approximately 4,000 clinic sites nationwide.
To address issues arising with vaccine shortages for the potentially serious disease, the CDC developed a limited distribution plan with Sanofi Pasteur in France give out small quantities of Stamaril, another fever vaccine, until YF-VAX production resumes in the United States in mid-2018. Stamaril is available in more than 70 countries across the globe but is not currently licensed for use in the United States.
Through an Expanded Access Investigational New Drug (IND) program, the CDC and Sanofi Pasteur targeted clinic sites that administered greater numbers of yellow fever vaccine to international travelers in 2016 or provide coverage to an area that meets a geographic need for Stamaril distribution. An Expanded Access IND program is similar to a clinical trial, and a limited number of clinical sites can participate in the program.
“Recognizing the importance of yellow fever vaccination for military personnel and international travelers, Sanofi Pasteur has been working with U.S. FDA, CDC, DoD (Department of Defense) 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,” the company said.
Sanofi Pasteur is experiencing delays in the production process of its YF-VAX vaccine while it transitions production to a new state-of-the-art facility planned for mid-2018.
The CDC said when YF-VAX is no longer available, it will publish a list of clinic sites offering Stamaril on the travel section of the CDC website.