Important studies of vaccination safety data are being withheld by U.S. drug regulators, who say they cannot be untangled or separated from legally protected internal discussions.
The FDA used Empirical Bayesian data analysis to examine the CV-19 vaccinations, a technique that entails matching the adverse events reported after a particular vaccine with those recorded after taking the shot to those who never took one.
The FDA plans to mine data “at least monthly” to look for adverse events “reported more often than anticipated after immunization with COVID-19 vaccines,” per standard operating procedures established in Jan 2021 and Feb 2022. The government would take information from (VAERS).
The FDA data office recently responded to a request from Real News Cast, saying that the agency would not share any of the studies, even with redactions.
The government is withholding the documents under the Freedom of Information Act “that would not be accessible by legislation to a party other than an organization in dispute with the agency” exemption because they are internal agency communications between departments.
The bureau also tried to point to the United States Code, which also said that “all interactions only within Executive Branch of the United States government that are in printed form or that are largely limited to written form may be kept confidential from disclosure requirements except for factual data which again is fairly segregable in accordance with the statute formed in § 20.22 is accessible to the public. disclosure.”
Why the FDA was unable to provide copies of the analysis with irrelevant material blacked out is unclear. The Epoch Times is disputing the decision made by the archives department. The FDA did not provide a statement because of the appeal.
‘Unacceptable’
Woodymatters co-founder and advocate for a more robust FDA and medication safety system Kim Witczak expressed her displeasure with the agency’s unwillingness to provide the assessments.
Witczak, who serves in one of the FDA’s external advisory groups, stated to Real News Cast “The secrecy is inappropriate for an institution that says it is forthright with the public regarding vaccination safety.”
And, “What’s the benefit of even having VAERS if you’re not sharing it to the public?” she said.
Witczak said recent research by Dr. Joseph Fraiman & colleagues increased her doubts about the safety of vaccines since it indicated a greater prevalence of major adverse events among vaccinated patients in the first Pfizer & Moderna vaccine studies compared to placebo recipients. She pointed out that the FDA’s warning in 2004 that antidepressants could raise the risk of suicidal thoughts and conduct was issued well over a decade after the studies upon which it was founded.
Witczak remarked, “If this information is accessible, shame on all of you for never disclosing it to the public.” They don’t seem to believe that individuals know what’s best for themselves and their families.
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