Stamaril Yellow Fever Vaccine Study
Principle Investigator: Julio Ramirez, MD
In 2017, Sanofi Pasteur provided notification to the FDA that the existing supply of Yellow Fever Vaccine (YF-VAX) would soon be exhausted due to manufacturing operational changes. The company also produced another Yellow Fever vaccine, Stamaril, used by all countries except the US and that product was produced in France. In response to the lack of availability of YF-VAX, the need for worldwide vaccine access, and the alternative availability of Stamaril, the FDA and CDC worked together to make Stamaril available for access in the US via a small number of vaccine clinics during the period of time necessary to restore the US supply of YF-VAX. The University of Louisville Travel Clinic was selected as one of those vaccine sites. The Expanded Access IND Program (EAP) to Provide Stamaril® Vaccine to Persons in the United States for Vaccination Against Yellow Fever (YF) study was created in partnership with Sanofi Pasteur and approval by the FDA. The principle investigator on this study is Dr. Julio Ramirez, Chief, Division of Infectious Diseases, at the University of Louisville. The main objectives of this study are to provide the Stamaril YF vaccine under an EAP and to collect passive surveillance safety data of the Stamaril vaccine. This EAP is conducted in approximately 250 YF vaccination clinical sites authorized by state health departments to validate an International Certificate of Vaccination or Prophylaxis for YF vaccination in the United States.
YF is a is a mosquito-borne hemorrhagic disease that is caused by a single-stranded RNA virus belonging to the genus Flavivirus. Approximately 200,000 YF-associated cases and 30,000 YF-associated deaths have been estimated to occur worldwide each year. The case-fatality ratio of YF varies widely in different studies but is typically 20% or higher. Stamaril is a live attenuated yellow fever vaccine, approved for use in more than 100 countries worldwide impacted by YF.
When the YF vaccine licensed by the United States Food and Drug Administration is not available, the Stamaril vaccine will be offered under this EAP to persons ≥ 9 months of age in the United States who are at high risk for YF, including researchers, laboratory workers, vaccine production staff, and those traveling within 30 days to YF-endemic areas or to countries requiring proof of YF vaccination under International Health Regulations (IHRs). Stamaril vaccine will be administered to potential vaccinees as part of this EAP under the same clinical procedures as for administration of YF vaccine. This option for Stamaril vaccine intended for prevention of YF is available in the Vaccine & International Travel Clinic