CSI supported a very challenging request from a client for a Quadrivalent Flu Vaccine Study (Northern Hemisphere).
We are aware of the seasonal nature of this product, which means one single production per year (in the summer) with the combination of viruses predicted around April by the World Health Organisation (WHO) to be the dominant strains for that flu season.
The vaccine doses are typically booked well in advance (approximately in January) by customers and there is very little oversupply. When our client was ready to run the study, several USA manufacturers were already overbooked. This was a key factor in our recommendation between the available manufacturers: Sanofi and GSK.
The trial sponsor wanted to use the product from the same manufacturer in the USA and Europe.
USA manufacturers were already overbooked versus their production and would have been unable to supply the required quantities. CSI was able to demonstrate equivalency with the EU product and offered it in sufficient quantity. The trial also ran in Thailand and, due to difficulties with import, we were also able to offer the same product sourced locally.
With a flu vaccine trial, the cost of getting the sourcing wrong is punishing.
The Southern Hemisphere is a poor option to run a flu trial given the limited choice of countries and the fact that the flu season and circulating strains are much less defined in Southern Asia.
Given that supplies are only made once a year and quickly get booked, failing to secure the supplies means postponing the study by one full calendar year.
CSI provided scientific advice and guidance, regulatory information, and robust sourcing options to safeguard the study.