By Tom Ozimek
Conservative public interest advocacy group Defending the Republic (DTR) has obtained almost 15,000 pages of Moderna’s COVID-19 vaccine clinical trial data, claiming the data show an “utter lack of thoroughness” of the trials and calls the vaccine’s safety into “serious doubt.”
As a result of successful Freedom of Information Act (FOIA) litigation against the U.S. Food and Drug Administration (FDA), the group recently announced it had obtained—and is releasing—nearly 15,000 pages of documents relating to testing and adverse events associated with “Spikevax,” Moderna’s COVID-19 vaccine.
Since 2022, the group has been involved in litigation against the FDA relating to the production of data submitted by Moderna in support of its application to federal regulators for approval of its vaccine.
As a result, the FDA agreed to produce around 24,000 pages of the Moderna records by the end of this year, with the 15,000 pages being the first instalment.
The records, some of which relate to adverse events related to the vaccine, include important information related to the safety profile of Spikevax, which was first authorized for emergency use in the United States in December 2020 and in January 2022 received full approval for adults.
“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement earlier this year.
But the new data call this view into question. The advocacy group says that the tens of thousands of pages of clinical trial data released by the FDA supports the conclusion that there is “serious doubt” about both the safety of Spikevax and the FDA’s standards for approval.
Neither Moderna nor the FDA immediately responded to a request for comment.
DTR filed its FOIA lawsuit after the FDA rejected requests to produce the Moderna COVID-19 records, justifying its decision by claiming there was no pressing need for the public to review the information.
The documents obtained as part of the group’s litigation against the FDA are the first significant release of data from Moderna’s COVID-19 clinical trials.
The studies reveal the causes of deaths, serious adverse events, and instances of neurological disorders potentially associated with Spikevax.
One of the key takeaways from the documents is that many of those who died after receiving the Moderna vaccine were not given an autopsy.
“According to one study, 16 individuals died after being administered the Moderna vaccine. The study’s authors indicated that out 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,’” DTR said in a statement.
“Yet this did not stop those running these ‘studies’ from concluding, despite the absence of evidence, that the Moderna vaccine was not related to these deaths,” the group added.
As an example, the group gave the case of a 56-year-old woman who experienced ‘sudden death’ 182 days after receiving the second dose of the Moderna vaccine.
“The cause of death was unknown, and no autopsy was conducted. It seems they purposely decided not to investigate suspicious deaths in case the Moderna vaccine might be the cause,” the group stated.
There were also numerous examples in the clinical trial data of participants diagnosed with post-vaccination Bell’s Palsy and Shingles, with numerous vaccinated trial participants seeing the onset of Shingles less than 10 days after getting the shot.
The studies also showed that there were a number of serious adverse events noted in the vaccinated groups, with a number of participants experiencing heart attacks, pulmonary embolisms, and spontaneous miscarriages.
Overall, the group concludes that the 15,000 pages of data create “serious doubt concerning the safety of the Moderna vaccine and the FDA’s standards and approval of the Moderna vaccine.”
The 15,000 pages or so of data released by DTR, all of which can be found here, add to the growing body of evidence suggesting that the COVID-19 vaccines may not be as safe as advertised.
FDA Ordered to Speed Up Release of COVID-19 Data
Elsewhere, a federal judge in Texas ordered the FDA to make public data it relied on to license COVID-19 vaccines at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of about 23.5 years.
In a May 9 decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the agency was ordered to produce the data on Moderna’s vaccine for adults and Pfizer’s for children about 10 times faster than the agency wanted.
“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order (pdf), which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month.
The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.
The January 2022 order (pdf), also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.
“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.
The latest order requires the FDA to produce all of its data on Pfizer’s COVID-19 vaccine for 12- to 15-year-olds (and Moderna’s product for adults) by June 31, 2025.
FDA officials didn’t respond to a request for comment on the ruling.