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Children’s Health Defense (CHD) today filed a lawsuit in D.C. Federal Court against the U.S. Food and Drug Administration (FDA) to obtain documents related to the agency’s safety monitoring of the COVID-19 vaccines through the Vaccine Adverse Event Reporting System (VAERS) database.

The lawsuit alleges the FDA violated provisions of the Freedom of Information Act (FOIA) by refusing to provide key analysis of reports in the vaccine safety database.

CHD submitted the FOIA request in July 2022.

The FDA claimed the records sought are fully exempt from disclosure under FOIA because they are part of internal and intra-agency memoranda that include opinions and discussions protected by law, and because the records include discussions of legal and policy matters protected by attorney-client privilege.

Mary Holland, CHD president and general counsel, took issue with the FDA’s position.

“The public must have truthful, complete information about the risks and benefits of these drugs, and others,” Holland told The Defender.

FDA analyzes VAERS data but doesn’t make its results public

The Centers for Disease Control and Prevention (CDC) and the FDA jointly administer VAERS, a database that allows healthcare professionals and others to file reports about vaccine-related injuries.

While reports don’t prove causality, the CDC considers VAERS to be a key “early warning system” for detecting unusual or unexpected patterns of adverse event reporting that can signal safety problems with a vaccine.

According to the co-sponsored VAERS’ “Standard Operating Procedures for COVID-19,” dated January 2021, the CDC and the FDA would coordinate monitoring for “potential new safety concerns for COVID-19 vaccines” by performing routine VAERS surveillance.

Each agency would use a different standard approach to data mining to screen for potential safety signals.

The CDC would run Proportional Reporting Ratio (PRR) data mining on a weekly basis, or as needed.

The FDA would conduct a bi-weekly thorough manual review of serious adverse events and through Empirical Bayesian data mining, which uses a statistical method to compare adverse events related to the COVID-19 vaccine with those related to non-COVID-19 vaccines in order to identify safety signals.

CHD requested these data, along with records of the FDA’s communications with the CDC’s Immunization Safety Office regarding the CDC’s own COVID-19 vaccine safety monitoring.

The FDA on Oct. 4, 2022, denied CHD’s FOIA request in its entirety.

The FDA cited a FOIA exemption that protects inter- and intra-agency communications “consisting of opinions, recommendations, and policy discussions within the deliberative process of FDA, from which factual information is not reasonably segregable.”

The FDA claimed that because “the information also contains 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 information was exempt from the FOIA request.

CHD’s administrative appeal, filed in November 2022, addressed the FDA’s failure to explain why it would be impossible to segregate and disclose non-exempt information, what basis it had for claiming attorney-client privilege or whether the FDA had even searched for the records.

The FDA indicated that a response to those concerns would take 9 to 12 months.

In a separate-but-related FOIA request submitted in September 2022, CHD requested the records from the Empirical Bayesian data mining underlying the analysis published by FDA and CDC scientists in May 2022, in their death reporting rates article.

The article analyzed death reports in the VAERS database using the methods laid out in the operating procedures document, demonstrating the agencies are in fact doing this analysis are not making the data public.

The FDA has not responded to this request, other than to acknowledge its receipt.

In today’s lawsuit, CHD alleges the agency improperly withheld these data from the public as the FOIA time limits have long passed. The lawsuit asks the court to compel the FDA to comply with the FOIA requests.

CDC analysis showed hundreds of safety signals, FDA’s analysis likely does, too

Earlier this month, The Epoch Times obtained the results of the CDC’s analysis of the VAERS information, which indicated hundreds of safety signals for the Moderna and Pfizer COVID-19 vaccines.

The Epoch Times investigation obtained the CDC’s PRR data mining analysis through a FOIA request. The CDC analysis was conducted on adverse events reported from Dec. 14, 2020, to July 29, 2022.

The analysis identified signals for serious conditions, such as blood clotting in the lungs, intermenstrual bleeding, a lack of oxygen to the heart and even death.

According to emails sent by a CDC spokesperson to The Epoch Times, the CDC results “were generally consistent with EB data mining, revealing no additional unexpected safety signals.”

A letter from the CDC records office to The Epoch Times also confirmed that the CDC “generally corroborated findings from Empirical Bayesian (EB) data mining [the FDA’s analysis].”

It is the FDA’s analysis of the Empirical Bayesian data that CHD wants the court to compel the FDA to release.

Agency’s withholding of data is ‘reprehensible’

Mary Holland, president and general counsel of CHD, told The Defender the agency’s refusal to make this information available to the public was unacceptable.

“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.

“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.”

This isn’t the first time the FDA and CDC failed to make important data publicly available.

Moderna and officials at the FDA and CDC last year withheld data on Moderna’s bivalent boosters from the agencies’ vaccine advisory committees when they met to discuss whether the shot should be authorized.

In May 2022, the FDA released documents pertaining to the Emergency Use Authorization of the Pfizer vaccine, as part of a court-ordered disclosure schedule stemming from an expedited FOIA request filed in August 2021.

In the lawsuit that ultimately compelled the release of that data, the FDA requested 75 years to make the data publicly available.

In July 2022, The Epoch Times filed a FOIA request to the FDA similar to the one filed by CHD, seeking analysis from the Empirical Bayesian data mining. The FDA responded that it would not provide any of the analyses, even in redacted form, citing the same FOIA exemption it cited in this case.

CHD also filed a FOIA request to the CDC in August 2022, seeking records of any PRR conducted by the CDC in connection with COVID-19 vaccines from Oct. 1, 2021, to the present, and of any follow-up investigation done in connection with those results.

CHD also asked for records of internal CDC communications discussing PRRs and safety signals. The CDC has not yet provided those records.

According to the FDA FOIA Logs, between Oct. 1, 2020, and Sept. 30, 2022, more than 600 COVID-19-related FOIA requests were submitted to the FDA. The logs do not indicate the status of the requests.

The FDA and the CDC are “deliberately reneging on what their mission is,” according to Dr. Meryl Nass, internist and biological warfare epidemiologist, who called out health agencies for hiding data relating to COVID-19 vaccines and pregnancy during an interview on “RFK Jr. The Defender Podcast.”