How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule
Challenge
CSI was approached to support a quadrivalent influenza vaccine study running in multiple countries in the Northern Hemisphere. The sponsor wanted to use the same product across all participating countries in the trial.
Due to the seasonal nature of this vaccine, there is only one production run per year, which takes place each summer: manufacturers look at predictions from the World Health Organization (WHO) for what the dominant flu strain will be the following winter and produce vaccines accordingly. The vaccine doses are typically booked well in advance by customers – around January – and there is very little oversupply.
Solution
When our client was ready to run the study, several manufacturers in the United States were already overbooked versus their production and would not have been able to support the requirements of the trial in all regions.
CSI was able to leverage its longstanding relationship with a major European manufacturer that could supply the product in the quantity required for the whole trial. Working with this manufacturer, CSI demonstrated the equivalence of the EU and USA products. The trial also ran in some South East Asian countries; in order to bypass tricky import requirements, CSI sourced the product locally in these countries.
Result
With a flu vaccine trial, getting the sourcing wrong can be very costly. Failure to secure supplies would postpone the trial by a full calendar year since the Southern Hemisphere is a poor option when it comes to running a flu vaccine trial, having fewer countries and a circulation of poorly defined flu strains.
CSI provided sound scientific and regulatory guidance alongside a robust sourcing option that ultimately safeguarded the entire study. Without this strategy, the trial would have been delayed by one year at great expense to the sponsor.
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