Will United States air carriers assist with transporting a vaccine from the Republic of Cuba to the United States with a series of commercial (paid) deliveries from the Jose Marti International Airport (HAV) in Havana, Republic of Cuba, to Buffalo Niagara International Airport (BUF) in Cheektowaga, New York?
In April 2015 Buffalo, New York-based Roswell Park Cancer Institute (RPCI) signed an agreement with the Republic of Cuba government-operated Center for Molecular Immunology (CIM) to develop a lung cancer vaccine with a clinical trial in the United States.
In August 2016, RPCI received authorization from the United States Food and Drug Administration (FDA) to commence (this year) a Phase One Clinical Trial of the lung cancer treatment vaccine CIMAvax-EGF® to a limited number of patients.
In October 2016, RPCI received authorization from the Office of Foreign Assets Control (OFAC) of the United States Department of the Treasury to establish a commercial joint venture with the CIM, to established in the Mariel Special Development Zone (ZEDM) and which will be the first commercial joint venture with a United States-based entity in the Republic of Cuba licensed to research, develop, manufacture and market biotech products in the Republic of Cuba.
In October, as a test, the CIM sent to RPCI four (4) cartons (approximately 30 pounds each) of vials containing saline from the Republic of Cuba to the United States.
The cartons were sent on an Dorval, Canada-based Air Canada flight from HAV to Toronto Pearson International Airport (YYZ) in Toronto, Canada, and then transported by truck to a border crossing near Buffalo, New York, before being delivered to RPCI.
This first trial effort took almost one week, end-to-end, primarily due to U.S. Customs and Border Protection (CBP) not having processing documentation uploaded to the automated cargo processing applications. RPCI and the FDA are working on eliminating issues with the importation process.
Given the vaccine must be maintained at a constant temperature, critical to develop an efficient and consistent supply chain- one that crosses from one country to the other rather than a triangular model. The goal is to have the product delivered the same day.
RPCI intends to commence the Phase One Clinical Trial in 2016, which will coincide with the implementation of regularly scheduled commercial airline schedules from HAV to Newark Liberty International Airport (EWR) in Newark, New Jersey (United Airlines); from HAV to John F. Kennedy International Airport (JFK) in Queens, New York (Delta Air Lines & JetBlue Airways); and from HAV to Charlotte Douglas International Airport (CLT) in Charlotte, North Carolina (American Airlines). These four (4) commercial airlines have continuing services from EWR to BUF, from JFK to BUF, and from CLT to BUF. Memphis, Tennessee-based FedEx (FDX) is also operating regularly-schedule cargo service.
There will be six (6) shipments of the vaccine during the next twelve (12) months; not necessarily on a regular schedule. Approximately five hundred (500) vials per shipment contained in four (4) cartons of approximately thirty (30) pounds per carton. The shipment temperature needs to remain from 4 to 8 degrees C; there will be internal temperature monitoring equipment in each carton.