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Apr 28, 2017 - According to the Centers for Disease Control and Prevention (CDC), the supply of yellow fever vaccine available in the United States is rapidly dwindling and is on track to be completely depleted by summer. But imported supplies from France should be able to cover US populations in need of the vaccine until next year.
A report in this week's Morbidity and Mortality Weekly Report (MMWR) describes how manufacturing problems at Sanofi Pasteur, the producers of the vaccine used in the United States, have led to this supply problem. A number of vaccine doses were lost while Sanofi was transitioning vaccine production from an old site to new construction, slated to open in 2018.
The United States uses 500,000 doses of yellow fever vaccine each year, distributed to travelers and military personnel who will be visiting yellow fever–endemic regions. Just 1 dose of the vaccine confers lifelong immunity, with recipients showing 80% immunity to yellow fever virus 10 days after inoculation and 99% immunity within 30 days. According to unpublished data from Sanofi, approximately 60% of these doses are distributed among about 4,000 civilian clinical sites.
Sanofi imports eIND vaccine
By the summer of 2016, with a yellow fever outbreak raging in Angola and the Democratic Republic of the Congo, Sanofi submitted to the Food and Drug Administration (FDA) an expanded access investigational new drug (eIND) application. This would allow the company to import the yellow fever vaccine manufactured by Sanofi Pasteur France. The FDA accepted the application in October of 2016. That vaccine, Stamaril, was distributed to 252 clinic sites in the United States this month.
"Although the systematic site selection process for the distribution of Stamaril took into account site volume (giving preference to larger sites) and adequate geographic reach, accessibility difficulties for some international travelers might occur because of the decrease in the number of clinics nationwide that provide yellow fever vaccination from 4,000 to 250, " the authors write. They say the CDC will work closely with Sanofi to monitor the supply of Stamaril at the chosen clinic sites.
Photo: Sanofi Pasteur