Sanofi Pasteur confirms that YF-VAX® (Yellow Fever Vaccine) is unavailable to order in the U.S. until 2020 as the company transitions production to a new state-of-the-art facility.
Sanofi Pasteur has worked with the FDA to make another yellow fever vaccine, Stamaril®, available in the US through an Expanded Access Investigational New Drug Application (IND).
Stamaril is indicated for active immunization against yellow fever in persons:
- traveling to, passing through or living in an endemic area
- traveling to any country that requires an International Certificate of Vaccination for entry (which may or may not depend on the previous itinerary)
- handling potentially infectious materials (e.g. laboratory personnel)
The vaccine should be given at least 10 days before entering an endemic area since protective immunity may not be achieved until at least this time has elapsed.
Stamaril is registered and distributed in over 70 countries.
However, it is considered investigational in the US, as it is not a US-licensed product. The Expanded Access Program has requirements similar to a clinical trial; thus Sanofi Pasteur can support only a limited number of sites.
Working closely with the CDC, geographically distributed sites throughout the US are identified for inclusion in the program so patients can have continued access to the yellow fever vaccine.
In order to comply with vaccine regulations and to be officially recognized, yellow fever vaccines must be administered in an approved World Health Organization (WHO) vaccination center and registered on an International Certificate of Vaccination.
Stamaril is indicated for adults and children aged 9 months and older.
However, children from 6 to 9 months of age, it is not recommended except in specific circumstances and in accordance with available official recommendations.
And children under 6 months of age should not be given the vaccine.
The validity period of this Certificate is established according to International Health Regulations (IHR) recommendations, and starts 10 days after primary vaccination and immediately after re-vaccination.
The duration of protection following administration of one single 0.5 ml dose of Stamaril is expected to be at least 10 years and may be life-long.
Re-vaccination with one dose of 0.5 ml may be needed in some individuals who had an insufficient immune response after their primary vaccination.
Re-vaccination may also be required, depending on official recommendations of local Health Authorities, as a condition of entry in some countries.