Addressing a Yellow Fever Vaccine Shortage — United States, 2016–2017

Abstract

What is already known about this topic? Effective and safe yellow fever vaccines are available to prevent yellow fever disease among persons traveling to countries with yellow fever virus transmission and to comply with individual country yellow fever vaccination entry requirements; only one yellow fever vaccine (YF-VAX) is currently licensed for use in the United States. Periodic, temporary yellow fever vaccine shortages have occurred in the United States as a result of manufacturing problems, including a manufacturing complica­tion in 2016 that resulted in the loss of a large number of U.S.-licensed yellow fever vaccine doses. What is added by this report? To avoid a lapse in yellow fever vaccine availability to persons in the U.S. population for whom yellow fever vaccination is indicated, public health officials and private partners collaborated in pursuing an expanded access investigational new drug (eIND) application for the importation of Stamaril yellow fever vaccine into the United States. Stamaril is produced by Sanofi Pasteur, the manufacturer of the U.S.-licensed YF-VAX, and it uses the same vaccine substrain. A systematic, tiered process was developed to select clinics to participate in the eIND protocol, with the goal of reasonable accessibility to yellow fever vaccination for all U.S. residents, while assuring that clinic personnel could be ade­quately trained to participate in the protocol. What are the implications for public health practice? Providers need to be aware that there is a yellow fever vaccine shortage and there is a plan for providing safe vaccine at a limited number of clinics until the supply is replenished. Domestic production of yellow fever vaccine in the United States should resume in 2018, and as the eIND protocol is implemented, CDC and Sanofi Pasteur will need to continue to collaborate throughout site recruitment and training, partner to resolve issues that arise, and maintain communication with health care providers and the general public.