US Gov’t, Sanofi Update Production Shortfall for Yellow-Fever Vaccine
Due to an expected shortage of Sanofi’s YF-VAX yellow fever vaccine because of a manufacturing issue with Sanofi Pasteur, the vaccines arm of Sanofi, the US Centers for Disease Control and Prevention (CDC) and Sanofi Pasteur have outlined a plan to ensure a continuous yellow fever vaccine supply in the US following the anticipated depletion of YF-VAX in mid-2017.
In March 2016, Sanofi Pasteur had a manufacturing issue and implemented ordering restrictions to responsibly manage supply of YF-VAX. In April 2017, the company also said it is experiencing delays in the production process of YF-VAX while it transitions production to a new facility planned for mid-2018. The company has put contingency plans into place since it first started having trouble with production in March 2016. However, the company anticipates that the product will be unavailable in the US beginning mid-2017 and extending to mid-2018, Sanofi Pasteur said in a company statement. YF-VAX is the only yellow fever vaccine licensed for use in the US and is distributed to approximately 4,000 clinic sites, according to the CDC.
To ensure availability of a yellow fever vaccine in the US during the YF-VAX shortfall, the CDC and Sanofi Pasteur have collaborated on a plan to distribute limited quantities of Stamaril (yellow fever vaccine [live]) through an expanded access investigational new drug (IND) program with the US Food and Drug Administration (FDA). The expanded access IND program will allow for Stamaril to be imported and distributed in the US until production of YF-VAX resumes in 2018. Stamaril, a live, attenuated yellow fever vaccine, is manufactured by Sanofi Pasteur in France. It is investigational and not currently licensed in the US, but is registered and distributed in more than 70 countries. In October 2016, the FDA authorized the expanded access IND protocol that allows for Stamaril to be distributed to designated US clinic sites until YF-VAX production resumes at Sanofi Pasteur’s new facility.
To ensure broad accessibility to limited quantities of the Stamaril vaccine, Sanofi Pasteur and the CDC have targeted clinic sites that administered a high volume of yellow fever vaccine to international travelers in 2016 or can provide coverage to an area of geographic need. Based on these criteria, Sanofi Pasteur identified approximately 250 US clinics to distribute Stamaril. In the meantime, YF-VAX will continue to be available while current supplies last.