Yellow Fever Vaccine Administration at Global TravEpiNet (GTEN) Clinics during a Period of Limited Vaccine Availability in the United States, 2017–2018

In 2016, Sanofi Pasteur (S-P) experienced a manufacturing disruption of yellow fever vaccine (YF-Vax), the only U.S.-licensed YF-Vax, depleting the U.S. supply by mid-2017. Sanofi Pasteur received approval to import Stamaril, S-P's French-manufactured YF-Vax, for use in 260 U.S. civilian clinics under an expanded access investigational new drug program (EAP). The CDC also broadened its YF-Vax 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 YF-Vax usage, unavailability, and reasons for refusal. We also performed a brief voluntary survey of GTEN sites to better understand their experience during the shortage. Yellow fever vaccine 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, YF-Vax usage following initial vaccine availability limitations did not change until vaccine recommendations were broadened. Refusal of recommended YF-Vax 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.