Case Study – Sourcing Flu Vaccines for a Global Study
CSI was approached to support a quadrivalent flu vaccine study running in multiple countries in the Northern Hemisphere. The sponsor also wanted to use the same product in the trial across all participating countries.
Due to the seasonal nature of this vaccine, there is only one production run per year (in the Summer), manufacturers look at predictions from the WHO of what the dominant flu strain will be in the Winter and then produce vaccines accordingly. 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 versus their production and would not have been able to support the requirements of the trial in all regions alongside their current orders.
CSI was able to leverage its relationship with a EU manufacturer that could supply the product in the quantity required for the whole trial. Working with this manufacturer CSI demonstrated the equivalency between the EU an USA products. The trial also ran in some South East Asian countries, to bypass tricky import requirements CSI sourced the product locally in these countries.
Challenges and Results
With a flu vaccine trial, the cost of getting the sourcing wrong is very significant. Failure to secure supplies would postpone the trial by a full calendar year as the Southern Hemisphere is a poor option to run a flu vaccine trial (less countries, and poorly defined flu strains circulating).
CSI provided sound scientific and regulatory guidance alongside a robust sourcing option that ultimately safeguarded the study.
The advantages of biosimilars vs branded products in clinical trials
The growth in the biosimilar market since 2006 has been significant.