QUOTE: The documents, previously submitted by Moderna to the U.S. Food and Drug Administration as part of the licensing process for Moderna’s Spikevax COVID-19 vaccine, included details on unexplained deaths and fetal abnormalities in animal studies.
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.
Travis Miller, a Fort Worth-based attorney representing DTR, told The Defender, “These documents include over 13,500 pages relating to serious adverse event listings that document injuries — such as shingles and Bell’s palsy and other more serious conditions — which we believe may be related to the Moderna COVID-19 vaccine.”
DTR also received documents describing experiments involving mRNA injections on rats in 2017-2018, prior to the onset of COVID-19. Miller told The Defender these studies revealed fetal abnormalities in pregnant rats.
Dr. Meryl Nass, an internist, biological warfare epidemiologist and member of the Children’s Health Defense scientific advisory committee, said the Moderna clinical trial data bear similarities to the outcomes seen in the Pfizer COVID-19 vaccine trials, and raise several questions about safety and liability.
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