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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.
Nass told The Defender:
“Both the preclinical (animal) studies of Moderna and of Pfizer revealed skeletal abnormalities in the offspring of vaccinated mice and rats at higher-than-normal rates and revealed vaccine components travelled throughout the body into all organs.
“Both the Pfizer and Moderna trial data in humans reveal concerning deaths and side effects that were attributed to other causes, but likely were vaccine side effects.”
Nass said “it appears” the FDA did not perform due diligence regarding the clinical trials for each vaccine.
“Did the FDA perform its required regulatory function to oversee the conduct of the trials?” Nass asked. “Or did Operation Warp Speed wave the vaccines through without a proper FDA review of the data?”
Nass asked “who is responsible” if the FDA failed to “perform its regulatory tasks?”
She said the clinical trial data also lead to questions about the liability shield enjoyed by vaccine manufacturers:
“If Moderna (and Pfizer) knew of more problems with the vaccines than they acknowledged, will they have liability under the PREP Act?
“Finally, pilot lots of vaccine (used for the clinical trials of the Pfizer vaccine, and likely the Moderna vaccine) were considerably different than lots made later, using different methods. This was noted by the European Medicines Agency.
“Therefore, do the clinical trial findings even apply to everyone else who received the vaccine later?”
Serious adverse events routinely classified as ‘unrelated’ to vaccine
Four of the six files contained in the documents released Tuesday contained data from the human clinical trials for the Moderna COVID-19 vaccine. The documents date from between November 2020 and June 2021.
Miller criticized Moderna’s lack of scientific rigor in determining the causes of the deaths and adverse events, saying that, in several cases, “Individuals who died after receiving the Moderna vaccine were not given an autopsy.”
According to DTR, “The study’s authors indicated that of those 16 deaths, only two autopsies were performed, five of the dead were not autopsied, and the autopsy status of nine of the dead was ‘unknown.’”
In one instance, a 56-year-old woman experienced “sudden death” 182 days after receiving her second dose of the Moderna vaccine. The cause of death was listed as “unknown” and no autopsy was performed.
“It seems they purposely decided not to investigate suspicious deaths in case the Moderna vaccine might be the cause,” DTR stated in its summary.
Yet the deaths “did not stop those running these ‘studies’ from concluding, despite the absence of evidence, that the Moderna vaccine was not related to these deaths,” DTR added.
Several trial participants also developed neurological disorders, DTR said. “One 44-year-old female had ‘left side facial paralysis’ just eight days after the second dose” and “Numerous vaccinated participants saw the onset of shingles less than 10 days after vaccination.”
This was not the full extent of SAEs sustained by trial participants. According to DTR:
“Subsequent analyses of reports from the FDA VAERS [Vaccine Adverse Events Reporting System] database, the Department of Defense’s DMED [Defense Medical Epidemiological Database], and European regulators showed heightened rates of these illnesses following administration of the Moderna vaccine.”
VAERS has historically been shown to report only 1% of actual vaccine adverse events.
Similar to the Pfizer documents released last year, the Moderna documents indicate SAEs were routinely classified as being “unrelated” to the vaccine. According to DTR:
“… similar to their treatment of deaths post-vaccination, the studies seemed predestined to conclude that these serious adverse events — many of them life-threatening — were not related to the Moderna vaccine. It didn’t matter whether the adverse event occurred within days of vaccination.
“All this creates serious doubt about the safety of the Moderna vaccine and the standards by which it was approved by the FDA,” Miller said.
According to DTR, the documents also contained “troubling” evidence from animal studies.
Referring to the results of one study, DTR stated, “The findings of this study are troubling: the mRNA vaccine altered the skeletal variations of the rat fetuses and the ‘female pregnancy index’ of the vaccinated rats was significantly lower than the control group.”
Other abnormalities noted in this study included an above-average rate of “common skeletal variations consisting of wavy ribs and increase[d] nodules,” a “statistically significant higher” mean number of reproductive cycle lengths and a lower incidence of mating and pregnancy in the mRNA-1273 group rats compared to the control group.
Moderna included an older study, conducted in 2017 and 2018, prior to the COVID-19 pandemic, in its application for FDA approval. The study showed similar results, with mRNA found in several organs.
According to DTR, “Testing revealed that ‘mRNA-1647 was detected in all of the analyzed tissues except for kidney[s],’ with elevated levels of mRNA-1647 found in the spleen and eye. Notably, mRNA-1647 was detected in the brain and heart.”
FDA twice denied FOIA requests for release of the Moderna documents
Miller told The Defender that DTR sued Moderna after the FDA “wrongly denied our request for the expedited production of the records submitted by Moderna in support of its Biologics License Application (BLA) for its COVID-19 vaccine ‘Spikevax.’”
The lawsuit was filed June 7, 2022 in the U.S. District Court for the Northern District of Texas – Dallas Division — the same federal court that previously ordered the release of the FDA documents pertaining to the approval of the Pfizer COVID-19 vaccine. The court rejected the FDA’s proposed release schedule to make those documents public over a period of 75 years.
DTR said it reached an agreement earlier this year with the FDA for the production of approximately 24,000 pages of some of the most important records submitted by Moderna in support of its Biologics License Application.”
The agreement, announced March 31, required the FDA to release the first 13,685-page set of documents by July 17, and the remainder by the end of 2023.
The FDA granted full approval of Moderna’s Spikevax on Jan. 31, 2022. On Feb. 3, 2022, DTR filed a FOIA request with the FDA, “seeking the expedited production of records relating to the FDA’s approval of the Moderna COVID-19 vaccine.”
However, the FDA twice rejected DTR’s request — first on Feb. 9, 2022 and again on June 6, 2022 — claiming DTR had not shown “a compelling need for expedited processing” of the documents. DTR sued the FDA the following day.
While the lawsuit is still ongoing, Miller told The Defender it will be “dismissed per agreement by the parties” once the FDA provides the remaining documents.
According to Miller, these documents include:
- Moderna’s May 28, 2021 original application.
- Postmarketing reports of herpes zoster.
- Data related to unsolicited adverse events.
- Data relating to analysis and efficacy against severe COVID.
- Information on antibody quantification.
- Information on postmarketing vaccine effectiveness.
The documents are expected to be released by the end of the year.
Miller told The Defender he hopes the findings in the Moderna documents will “at a minimum, lead to further Congressional oversight of the FDA’s approval process and for accountability within that agency.”