So, what went wrong? In November 2015, as Sanofi Pasteur was in the process of transitioning “production” from their old facility to a new one that is estimated to open in 2018, “a manufacturing complication resulted in the loss of a large number of doses.” Sanofi Pasteur responded to this by ordering restrictions to temporarily prolong the supply. By spring 2016, the vaccine developers “notified CDC of a probable complete depletion of YF-VAX later in the year.” At the end of 2016, Sanofi Pasteur was able to produce more doses of the vaccine, but only enough to delay the anticipated complete depletion of the vaccine until mid-2017.
Sanofi Pasteur proceeded to submit an eIND application to import Stamaril, an alternative yellow fever vaccine that is not yet licensed in the United States. Much like YF-VAX, Stamaril uses the same vaccine substrain 17D-204 and offers “comparable safety and efficacy.” In fact, around 70 countries have already licensed and distributed the vaccine dating to 1986. Not only is it available in both single- or multi-dose vials, but Sanofi Pasteur “projects that importing Stamaril single-dose vials into the United States under the eIND application will not substantially affect the Stamaril supply intended for global use.”
After the FDA accepted the eIND application in October 2016, the CDC and Sanofi Pasteur got to work on developing a process to select sites where Stamaril would be available for distribution in the United States. They developed a “two-tiered scheme” for selecting clinical sites; Tier 1 would include “large-volume sites with adequate geographic range,” “additional smaller-volume sites…to ensure access to Stamaril in all 50 states, the District of Columbia, and the 3 US territories (Guam, Puerto Rico, and the US Virgin Islands),” and sites that would provide access for civilian US government employees who are traveling for work; Tier 2 would include “multistate clinical organizations.” As of April 2017, 250 clinics were identified for inclusion.
Although the site selection took into account site volume and geographic reach, some international travelers might face accessibility difficulties because of the significant decrease in the number of clinics that will provide the vaccine—from 4,000 to 250. The CDC and Sanofi Pasteur will work together to keep an eye out on any “critical gaps in vaccine access” and will work to address any issues they might find.
The CDC say that they will provide updates to the public as new information becomes available.
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