FDA Sued for Withholding COVID-19 Vaccine Safety Analyses

Zachary Stieber
By Zachary Stieber
January 28, 2023Vaccines
FDA Sued for Withholding COVID-19 Vaccine Safety Analyses
A sign for the Food and Drug Administration (FDA) is seen outside of its headquarters in White Oak, Md., on July 20, 2020. (Sarah Silbiger/Getty Images)

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.

After lying about when it started the proportional data mining and stonewalling inquiries, the CDC recently released the results of the analyses to The Epoch Times, revealing the agency identified hundreds of adverse events potentially connected to the Pfizer and Moderna COVID-19 vaccines.

Kim Witczak, co-founder of Woodymatters, a nonprofit that advocates for a stronger FDA and drug safety system, said at the time that the agency’s refusal to provide the analyses was not acceptable.

“The secrecy is unacceptable for an agency that said it is transparent with the public about vaccine safety,” Witczak said.

Lawmakers, including Rep. Ronny Jackson (R-Texas), have also questioned (pdf) why the records were not released.

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.

While exemptions exist, the FDA improperly withheld the requested data, the new lawsuit charges. It notes that the FDA did not provide any evidence to support its claims that it could not release the records.

While the CHD appealed to the government for a fresh look at the request, the FDA said it would not have a response to the appeal until “around” the summer of 2023.

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.

The FDA did not respond to a request for comment.

“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.”

From The Epoch Times

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