Sanofi Pasteur’s new state-of-the-art YF-VAX® production facility has been licensed by the U.S. FDA and the transition of production continues.
They are reassessing the YF-VAX return to supply timing and will provide an update by the end of 2019.
When a new vaccine manufacturing facility comes online, it may take some time to achieve consistent vaccine supply levels.
Vaccine manufacturing is a complex biological process that is highly regulated. Consequently, the construction and validation of a new facility often takes several years to bring a new facility online.
In the interim, Sanofi Pasteur has worked with the FDA to make another yellow fever vaccine available in the U.S. through an Expanded Access Investigational New Drug Application (IND).
Manufactured by Sanofi Pasteur in France, Stamaril® is registered and distributed in more than 70 countries. However, it is considered investigational in the U.S., as it is not a U.S.-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, more than 250 geographically distributed sites throughout the US were identified for inclusion in the program so patients can have continued access to the yellow fever vaccine.
When available, the YF-VAX is indicated for active immunization for the prevention of yellow fever in persons 9 months of age and older:
- Are living in or traveling to endemic areas
- Traveling internationally to countries that require evidence of vaccination from entering travelers
- Laboratory Personnel who might be exposed to virulent yellow fever virus or to concentrated preparations of the yellow fever vaccine strain by direct or indirect contact or by aerosols should be vaccinated
- A single dose provides protection for 10 years for most people
- The vaccine is a live, weakened form of the virus given as a single shot
Vaccination with YF-VAX is contraindicated in infants less than 9 months of age due to an increased risk of encephalitis.
Vaccination with YF-VAX is also contraindicated in lactating women who are providing breastmilk to infants less than 9 months of age due to the potential for transmission of vaccine virus in breastmilk.