A biopharma company was conducting a national, placebo-controlled Phase III study to assess the safety and effectiveness of a new COVID-19 vaccine in adults 18 years and older. Over the course of 27 months, the study enrolled 30,000 patients over the age of 18. The vaccine was administered at the start of the trial and a booster at one year.
Primary efficacy endpoints included the occurrence of molecularly confirmed moderate to severe/ critical COVID-19 at various time points after administration of the vaccine and again one year after the booster. Primary safety endpoints included the rate of local adverse events at the injection site, and the rate of serious adverse events including Thrombosis with Thrombocytopenia Syndrome (TTS).
The client, whose trial was already underway with a contract research organization (CRO), wanted to identify potential sources of data that would enable observation of COVID-19 infection rates and adverse events beyond the period of the trial to demonstrate the long-term effectiveness of their vaccine. In order to do so, the client needed to find and connect to real-world data (RWD) sources.
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