New Moderna COVID-19 vaccine clinical trial documents keep coming in from FDA, and recent batches include some unusually large files with more than 5 million rows of data.
As supporters may remember, this clinical trial data was wrested from the hands of FDA by the attorneys who regularly represent ICAN. FDA wanted to take 23 years to release the data but, instead, it was ordered to release all documents by June 2025. As of August 1, 2024, FDA has released approximately 1.4 million pages of Moderna data, out of an estimated 4.3 million pages total.
One large file recently released appears to be a “time to event” analysis of adverse events that occurred during the trial, including death. Crucially, it matches subject IDs with the arm of the trial each subject was in (vaccine vs placebo), which is data that was missing in several adverse event patient case reports previously received.
Several other data files appear to contain electronic diary data collected from clinical trial participants in the days following vaccination. It includes yes/no data on various symptoms they were experiencing (such as fever, headache, arthralgia (joint pain), and nausea) and whether those symptoms affected their ability to perform daily activities. It will be very interesting to compare the symptom rates in this data set with that of V-safe’s “check-the-box” data that we obtained from CDC in 2022.
We encourage those interested to download and examine these files for yourselves, and ICAN will continue to keep you posted as more Moderna documents roll in.
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