Abstract
In 2016, Sanofi Pasteur (S-P) experienced a manufacturing disruption of YF-Vax, the only U.S.-licensed yellow fever vaccine depleting the U.S. supply by mid-2017. Sanofi Pasteur received approval to import Stamaril, S-P's French-manufactured yellow fever vaccine, for use in 260 U.S. civilian clinics under an Expanded Access Program (EAP). The CDC also broadened its yellow fever vaccination indication in early 2018. Our objective was to assess usage at participating Global TravEpiNet (GTEN) clinics, a U.S. CDC-supported national consortium of clinical sites that administer vaccines, during this period of limited availability and changing recommendations. We analyzed 2012-2018 GTEN data for yellow fever vaccine usage, unavailability, and reasons for refusal. We also performed a brief voluntary survey of GTEN sites to better understand their experience during the shortage. YF-Vax unavailability at certain GTEN clinics was intermittent and recurrent, starting months before total depletion. Unavailability at GTEN clinics peaked weeks before the total depletion. Compared with historic norms, yellow fever vaccine usage following initial vaccine availability limitations did not change until vaccine recommendations were broadened. Refusal of recommended yellow fever vaccine also decreased during this period. Queried sites participating in the EAP felt their supply of vaccine was adequate. Our analysis suggests that in response to depletion of a travel vaccine, an EAP can make an unlicensed product available, patients will participate in such a program, and the program can respond to expanding recommendations for vaccine usage.