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By Zachary Stieber
January 28, 2023
The U.S. Food and Drug Administration (FDA) has been sued for withholding the results of key COVID-19 vaccine safety analyses.
The FDA’s actions violate federal law, the new lawsuit, filed on Jan. 26 in federal court in Washington by the nonprofit Children’s Health Defense (CHD), alleges.
The suit is seeking the raw results from the FDA’s analyses of reports to the Vaccine Adverse Event Reporting System (VAERS).
The system, which the FDA runs with the U.S. Centers for Disease Control and Prevention, accepts reports of post-vaccination adverse events.
As part of its vaccine safety monitoring, the FDA pledged to run a type of analyses called Empirical Bayesian (EB) data mining on the reports to see if any safety signals were triggered. Signals give agencies an idea of which problems may be caused by vaccines. Agencies are supposed to research signals to verify them or rule them unrelated to vaccination.
“A report to VAERS does not mean that a vaccine caused an adverse event. But VAERS can give CDC and FDA important information. If it looks as though a vaccine might be causing a problem, FDA and CDC will investigate further and take action if needed,” the CDC says on its website.
The FDA denied CHD’s request for the results of the data mining, claiming the records are “intra-agency memoranda consisting of opinions, recommendations, and policy discussions within the deliberative process of FDA, from which factual information is not reasonably segregable.”
The FDA also claimed the sought-after information “contains a discussion of legal and policy matters and fall within the attorney work product and attorney-client privileges as enunciated by the Supreme Court.”
The FDA also refused to provide the results of the EB data mining to The Epoch Times, using the same rationale.
In a set of operating procedures, the federal government said the FDA would carry out Empirical Bayesian data mining and the CDC would conduct a separate type of analyses using a method called Proportional Rate Ratio, or another way to analyze the VAERS data.
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The FDA and CDC only publicly acknowledge a small number of adverse events as being definitely caused by or potentially caused by the messenger RNA shots, including myocarditis, or heart inflammation.
The CDC claimed that the results of its analyses “were generally consistent with EB data mining.”
CHD says the refusal by the FDA to release the EB mining results violates the Freedom of Information Act, which enables people and organizations to request information from federal agencies.
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The Freedom of Information Act requires an agency to make requested records “promptly available” to a requester and imposes other time restrictions, which have not been adhered to, the suit says.
CHD is asking the court to find the FDA’s failures to meet the time requirements unlawful and order the FDA to produce all non-exempt records within 20 days. CHD is also asking the court to award attorneys’ fees and other litigation costs.
https://www.ntd.com/fda-sued-for-withholding-covid-19-vaccine-safety-analyses_897852.html
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The U.S. Food and Drug Administration (FDA) has been sued for withholding the results of key COVID-19 vaccine safety analyses.
The FDA’s actions violate federal law, the new lawsuit, filed on Jan. 26 in federal court in Washington by the nonprofit Children’s Health Defense (CHD), alleges.
The suit is seeking the raw results from the FDA’s analyses of reports to the Vaccine Adverse Event Reporting System (VAERS).
The system, which the FDA runs with the U.S. Centers for Disease Control and Prevention, accepts reports of post-vaccination adverse events.
https://noqreport.com/2023/01/28/reprehensible-fda-sued-for-withholding-covid-19-vaxx-safety-analyses-the-courts-will-command-the-fda-to-do-its-job/
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