The Food and Drug Administration (FDA) of the United States has been sued for withholding the results of critical COVID-19 vaccine safety analyses.
The FDA’s actions are in violation of federal law, according to a new lawsuit filed on Jan. 26 in federal court in Washington by the nonprofit Children’s Health Defense (CHD).
The suit seeks the raw results of the FDA’s analyses of Vaccine Adverse Event Reporting System reports (VAERS).
🚨BREAKING — FDA Sued for Withholding COVID-19 Vaccine Safety Analyseshttps://t.co/zl6rGmQVu4— James Cintolo, RN FN CPT (@healthbyjames) January 29, 2023
The system, which the FDA operates in collaboration with the Centers for Disease Control and Prevention in the United States, accepts reports of post-vaccination adverse events.
The FDA promised to run Empirical Bayesian (EB) data mining analyses on the reports as part of its vaccine safety monitoring to see if any safety signals were triggered. Signals inform agencies about which problems may be caused by vaccines. Agencies are supposed to investigate signals to confirm or rule them out as 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 data mining results, claiming the records are “intra-agency memoranda consisting of FDA deliberative process opinions, recommendations, and policy discussions, from which factual information is not reasonably segregable.”
The FDA also claimed that the requested information “includes a discussion of legal and policy matters and falls within the attorney work product and attorney-client privileges as enunciated by the Supreme Court.”
The FDA also refused to provide The Epoch Times with the results of the EB data mining, citing the same reason.
The federal government stated in a set of operating procedures that the FDA would conduct Empirical Bayesian data mining and the CDC would conduct a separate type of analysis using a method called Proportional Rate Ratio, or another way to analyze the VAERS data.
The CDC recently released the results of the analyses to The Epoch Times, revealing the agency identified hundreds of adverse events potentially linked to the Pfizer and Moderna COVID-19 vaccines after lying about when it began the proportional data mining and stonewalling inquiries.
At the time, Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said the agency’s refusal to provide the analyses was unacceptable.
“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak said.
Representative Ronny Jackson (R-Texas) has also questioned why the records were not released (pdf).
The FDA and CDC only publicly acknowledge a small number of adverse events, including myocarditis, as being definitely or potentially caused by messenger RNA shots.
According to the CDC, the findings of its analyses “were generally consistent with EB data mining.”
According to CHD, the FDA’s refusal to release the EB mining results violates the Freedom of Information Act, which allows individuals and organizations to request information from federal agencies.
While exemptions exist, the new lawsuit alleges that the FDA improperly withheld the requested data. It is noted that the FDA provided no evidence to support its claims that the records could not be released.
While the CHD requested that the government reconsider the request, the FDA stated that it would not respond until “around” the summer of 2023.
The Freedom of Information Act requires agencies to make requested records “promptly available” to a requester and imposes other time constraints, according to the lawsuit.
CHD is asking the court to declare the FDA’s failures to meet deadlines illegal and to order the FDA to produce all non-exempt records within 20 days. CHD also requests that the court award attorneys’ fees and other litigation costs.
The FDA did not respond to a comment request.
“It is long overdue for the FDA to release the data on the Empirical Bayesian data mining that it promised even before the COVID shot rollout” Mary Holland, president and general counsel of CHD, said in a statement. “It is reprehensible for this agency, established to protect the American people, to conceal critical data. I trust that the courts will command the FDA to do its job.”