In a follow-up to a CDC report from April, stocks of the only yellow fever vaccine licensed in the United States have been depleted, prompting the Food and Drug Administration to allow the use of an unlicensed yellow fever vaccine.
Last Monday, Sanofi Pasteur, the manufacturer of YF-VAX said their stock of the vaccine is totally depleted and will be unavailable for civilian use until mid-2018, when their new manufacturing facility is expected to be completed.
In the meantime, in anticipation of this temporary total depletion, in 2016, Sanofi Pasteur submitted an expanded access investigational new drug application to the Food and Drug Administration to allow for importation and use of Stamaril. The Food and Drug Administration accepted Sanofi Pasteur’s application in October 2016.
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Manufactured by Sanofi Pasteur in France, Stamaril is not licensed in the United States, but is licensed and distributed in approximately 70 countries, and has comparable efficacy and safety to YF-VAX.
During the interim period until YF-VAX is available again for use in the United States, Stamaril will be available in a limited number of designated clinics, selected to provide access to vaccine in U.S. states and certain territories.
Yellow fever is a disease caused by a virus spread by mosquito bites. Symptoms take 3–6 days to develop and include fever, chills, headache, backache, and muscle aches. About 15% of people who get yellow fever develop serious illness that can lead to bleeding, shock, organ failure, and sometimes death.
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