A 13,685-page tranche of documents related to Moderna’s COVID-19 vaccine clinical trials released Tuesday contain details about the deaths of 16 trial participants, the prevalence of severe adverse events (SAEs) and other abnormalities.
The documents, previously submitted by Moderna to the U.S. Food and Drug Administration (FDA) as part of the licensing process for Moderna’s Spikevax COVID-19 vaccine, also exposed an “utter lack of thoroughness” in how the trials were conducted, according to Defending the Republic (DTR), a Dallas-based nonprofit that obtained the documents via a a still-pending Freedom of Information Act lawsuit against Moderna.
The documents, shared with The Defender in advance of their public release, are the first set of “Moderna documents” to be released as part of the lawsuit — with approximately 8,000 more pages expected to follow later this year.