Conservative public interest advocacy group Defending the Republic 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."
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.
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.
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."
"Democracy dies behind closed doors," is how U.S. District Judge Mark Pittman opened his order, 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, 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.
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