Margaret Stroz, MD
International Travel Medicine Certification
It is estimated that approximately eight million United States residents traveled to 42 countries with Yellow Fever transmission in 2015. For travelers to those destinations, 500,000 doses of the yellow fever vaccine (YF-VAX) were provided to military and civilian travelers in the United States.
Half of one million is a large number, so one could only imagine the inconvenience felt when a construction delay impacted the number of available YF-VAX vaccines in the U.S.
This is the current situation for Sanofi-Pasteur, the only U.S. producer of YF-VAX. Beginning November 2015, supplies of the vaccine were already depleted as Sanofi began transitioning to a newer facility. What no one planned for was the manufacturing complication that resulted in a loss of a large number of vaccine doses. This depletion has been affecting numerous U.S. travelers and is expected to continue until the end of 2018.
The US Department of Health and Human Services and Centers for Disease Control (CDC) partnered with Sanofi to find a solution to the problem. Their first objective: ensuring supply meets demand. The CDC accepted an application from Sanofi for expanded access to an investigational new drug (eIND) that allowed the importation of the Stamaril Yellow Fever vaccine into the United States. Of importance here, the manufacturer of Stamaril is Sanofi-Pasteur. Essentially, it is the same vaccine and same parent company, but under a different name and regulation for distribution. Stamaril, studied and manufactured in France, has not applied for nor met FDA approval, so therefore was designated as an investigational new drug.
With adequate supply needs met, access to the vaccine also needed to be addressed. A systematic tiered process was developed whereby clinics who provided large numbers of the YF-VAX prior to the shortage were now allowed to provide the eIND Stamaril without FDA approval following a highly specific protocol. Although this allowed 250 designated Tier 1 clinics to provide the vaccine throughout the U.S., there has been a sizable reduction from the estimated 4,000 travel medicine sites previously providing YF-VAX, resulting in access inconveniences and back-log.
The Occupational Health Center and Travel Medicine Clinic at Chester County Hospital, part of Penn Medicine, has partnered with our colleagues at Penn Medicine Radnor, a Tier 1 Clinic, to address our traveler's needs. In order to assist Penn Medicine Radnor in seeing their increased number of travelers with Yellow Fever risk, The Occupational Health Center and Travel Medicine Clinic at Chester County Hospital continues to see all travelers first to assess risks, provide necessary vaccinations and prescriptions for the traveler's needs. And when Yellow Fever vaccine is recommended or required for our travelers, we provide ease of access through the back door to our Penn Medicine Travel Clinic in Radnor.
Inconvenience and delays may be encountered, but our team promises to provide quick access for our traveler's complete needs. Please plan accordingly, scheduling your travel medicine consultation well in advance of your planned travel dates.
Our motto: Be Informed. Be Prepared. Safe Travels.