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May 6, 2024 Agency Capture COVID News


CDC Stonewalls Requests for COVID Vaccine Safety Monitoring Documents

In response to a FOIA request, the CDC told Children’s Health Defense the agency has no records of certain internal email communications about the agency’s follow-up investigation of safety signals associated with COVID-19 vaccines.

freedom of information act (foia) with covid vaccine

The Centers for Disease Control and Prevention (CDC) told Children’s Health Defense (CHD) the agency has no records of certain internal email communications about the agency’s follow-up investigation of safety signals associated with COVID-19 vaccines.

In its response to CHD’s Freedom of Information Act (FOIA) request seeking key communications records associated with the agency’s analysis of safety signals in its Vaccine Adverse Event Reporting System (VAERS), the CDC said that “after a careful search of program emails,” it didn’t uncover any relevant documents.

“If the CDC carried out the follow-up investigations on safety signals detected in VAERS as described in the Standing Operating Procedures document for COVID-19, the agency should be able to provide CHD with the requested email communications and response plans,” Risa Evans, the CHD staff attorney who submitted the FOIA request told The Defender.

“The public would certainly benefit if the CDC and the FDA [U.S. Food and Drug Administration] made records of all their vaccine safety-monitoring activities fully available — regularly, and as a matter of course,” Evans said. “Unfortunately, even though the Freedom of Information Act requires transparency with respect to many of these records, actually obtaining them from the agencies is a challenge.”

CHD last week appealed the CDC’s response, alleging that the agency’s initial search was insufficient and it should check again.

“If the activities occurred, then the records exist, and the CDC should conduct the searches necessary to locate these records, which are clearly identified in the original FOIA request,” the appeal letter said.

In its appeal, CHD asked the CDC to conduct another thorough search within 20 days and provide a list of search terms and the accounts or domains searched.

According to the CDC and FDA protocols established in January 2021 as part of the VAERS Standing Operating Procedures, the agency should have been monitoring the database for safety signals and investigating those signals when they emerged.

The procedures document outlines the CDC’s VAERS surveillance protocols for the COVID-19 shots, including data processing, coding and follow-up, signal detection, and signal assessment.

As part of those protocols, the agency indicated that when it identified a safety signal warranting further investigation, the CDC’s VAERS team would notify leadership at the Immunization Safety Office (ISO), the FDA and other relevant agencies and develop a coordinated response plan.

It also said the ISO would notify the Vaccine Task Force and the leadership at the National Center for Immunization and Respiratory Diseases, a subagency of the CDC, about any follow-up investigation after a signal was detected.

CHD asked the agency to search all locations, departments and systems likely to have records related to some of these communications. It requested the relevant notifications from the VAERs teams to the ISO leadership and all coordinated response plans and notifications from ISO leadership to the other entities.

In the original FOIA request, CHD also asked for VAERS data review summaries that the procedures document says the CDC will provide to relevant stakeholders. In response, the CDC sent a list of presentations made to the CDC’s vaccine advisory committee since 2021. The response also included a list of publications on COVID-19 vaccine safety monitoring.

This information was already publicly available.

CHD has sued CDC before to obtain documents from its COVID VAERS analysis

Nearly 1.9 million adverse events, including close to 37,000 deaths, from COVID-19 have been reported to VAERS, the U.S. Department of Health and Human Services’ (HHS) “early warning system” for possible risks from a vaccine.

That number vastly exceeds the total number of adverse events for all other vaccines over more than three decades.

To determine if the shots caused these adverse events, the CDC and FDA are supposed to monitor and analyze the reports to detect safety signals.

A safety signal is a sign that an adverse event may be caused by vaccination, but further research is required to verify a link.

In February 2023, CHD filed a lawsuit in the U.S. District Court for the District of Columbia against the CDC to obtain documents related to the agency’s safety monitoring of the COVID-19 vaccines through VAERS.

In that request, CHD also sought information specified in the Standard Operating Procedures for COVID-19 document. That document stipulated that both CDC and FDA would monitor the VAERS data, with each agency using a different standard approach to data mining to screen for potential safety signals.

The CDC would run proportional reporting ratio (PRR) data mining weekly, or as needed. PRR would compare the reports of specific adverse events suffered after receiving a Moderna or Pfizer mRNA vaccine to reports made after receiving any other vaccine to see if there is an indication that the COVID-19 mRNA vaccines cause more adverse events than vaccines generally considered by the CDC to be safe.

The FDA would conduct a biweekly thorough manual review of serious adverse events using empirical Bayesian (EB) data mining, which uses a different statistical method to compare adverse events related to the COVID-19 vaccine with those related to non-COVID-19 vaccines to identify safety signals.

According to the CDC, if these types of data mining raised a safety signal, the agencies would do further analysis to confirm that the vaccine caused the adverse event — and share that data with the public.

Both agencies initially failed to make data public.

Both CHD and The Epoch Times began seeking information about this data via FOIA requests in 2022. In June 2022, the agency told CHD and Josh Guetzkow, Ph.D., who worked on the FOIA with CHD, that it had not monitored VAERS for safety signals as it had said it would.

In July 2022, the CDC told The Epoch Times that it had been doing the PRR analysis since June 2021 — directly contradicting what it had told CHD. In August 2022, the agency changed its position again, informing The Epoch Times that it had not been performing the analysis since 2021.

Instead, the agency said it began PRR analysis on March 25, 2022, and stopped again on July 31, 2022. A spokesperson told The Epoch Times that it confused PRR analysis with the EB data mining that the FDA had been doing. It said the analysis it had done was consistent with the FDA’s findings and the agency intended to rely on FDA’s data.

In January 2023, CHD filed a federal lawsuit against the FDA to obtain documents related to its empirical Bayesian data mining. In February 2023, CHD sued the CDC for its PRR data, which had not yet been released at that time.

CHD’s lawsuit sought to compel the agency to produce records it had requested through FOIA about the agency’s PRR analysis.

After CHD sued, the CDC did begin turning over documents related to the PRR analysis and other records, beginning in March 2023. Most of those documents are heavily redacted.

In August 2023, the CDC sent 512 pages of the requested documents to the FDA for a courtesy “consultation.” The court ordered the CDC to produce those records by the end of March 2024.

Instead, HHS filed a motion requesting to suspend the production of documents for 18 months, because it said the FDA was tied up and unable to complete the consultation.

CHD requested the court deny the HHS motion and compel CDC to produce the remaining documents.

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